Podcasts about en txt

Alternative Asset Management & Sustainability Insights

Play Episode Listen Later Feb 6, 2025 27:43

Medboard EU EU MDR and IVDR article 10a - Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods - Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdfEUDAMED EMDN: UPDATE or not to UPDATE - MDCG 2024-2 Rev 1 and 2021-12 Rev 1 : https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf Contact points of National Authorities - Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf EU Battery 2023/1542 - Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214 Swiss Maintenance of Medical Devices - Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html UK timeline for UKCA - Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf UK Post-Market Surveillance - Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type TUK Vigilance Reporting - Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems UK guide for IVD - Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf Training EU MDR training - Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/ Rest of the World: Laboaratory Developed Tests FAQ - Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests How to apply your dossier in Australia - Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment Malaysia guidance for HIV Self-test - Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file Import Medical Device for Personnal Use in Malaysia - What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file Alert by Philippines for Product registration - Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf Saudi Arabia clearance of Medical Devices - For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf China Medical Device Regulations Round-up 2024 - Cisema.com video: 2024 Round-Up of China Medical Device regulations India update classification lists - List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI= Podcast Episode 318 - How to register a Medical Device in South Africa - Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/ Episode 319 - How to perform your PMS for a Drug-Device Combination - Joan D'Souza: https://podcast.easymedicaldevice.com/319-2/ Episode 320 - Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/ Episode 321 - 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

Sustainability Insights: The role of government in transition finance

Play Episode Listen Later Oct 18, 2024 8:15

In this week's episode of Travers Smith's Sustainability Insights we are looking at the new UK government's approach to transition finance.Links:https://www.gov.uk/government/news/record-breaking-international-investment-summit-secures-63-billion-and-nearly-38000-jobs-for-the-ukhttps://www.cityam.com/bosses-at-worlds-biggest-banks-britain-is-ready-for-investment/https://www.gov.uk/government/speeches/pm-international-investment-summit-speech-14-october-2024https://www.gov.uk/government/news/game-changing-tech-to-reach-the-public-faster-as-dedicated-new-unit-launched-to-curb-red-tapehttps://www.cityam.com/rachel-reeves-promises-to-revolutionise-uk-capital-markets-and-boost-london-listings/https://www.gov.uk/government/news/dan-corry-appointed-to-lead-defra-regulation-reviewhttps://assets.publishing.service.gov.uk/media/670cde8692bb81fcdbe7b745/industrial-strategy-green-paper-final.pdfhttps://www.ukib.org.uk/https://www.british-business-bank.co.uk/finance-providers-equity-finance/british-growth-partnershiphttps://www.linkedin.com/posts/bvca_a-significant-step-forward-for-investment-activity-7251635037433991168-ztWw/https://www.theglobalcity.uk/PositiveWebsite/media/Research-reports/Scaling-Transition-Finance-Report.pdfhttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023H1425https://www.ft.com/content/c0ca95ce-ffcf-4c10-b789-174e359e16efhttps://player.captivate.fm/episode/457a3e0b-8938-43d1-8590-64e33625b7c0/https://url.uk.m.mimecastprotect.com/s/VBJCC8p4c9q036txt0FyxU-_?domain=sites-traverssmith.vuturevx.com

uk research finance transition sustainability role of government en txt

IVDR Class D – Lesson learned from Notified Bodies

Play Episode Listen Later Aug 6, 2024 28:58

The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now. Who is Andreas Stange? Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia. Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Andreas Stange Linkedin Profile: https://www.linkedin.com/in/andreasstange/ TÜV SÜD Website: https://www.axonlawyers.com/ EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320 Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

EU MDR Major update: Interruption or Discontinuation of supply!

Play Episode Listen Later Jul 30, 2024 49:01

The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”  Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ Axon Lawyers Website: https://www.axonlawyers.com/ EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 Medical devices: Council adopts new measures to help prevent shortages https://data.consilium.europa.eu/doc/document/PE-54-2024-INIT/en/pdf Article Judith de Wildth – How to prepare for article 10a: https://www.linkedin.com/posts/erikvollebregt_how-to-prepare-for-article-10a-mdr-as-a-manufacturer-activity-7216378083308646401-vqzF EUDAMED roll-out timeline: https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Aquavit: The Spirit of Scandinavia |S16E6

Play Episode Listen Later Jul 26, 2024 19:58

Aquavit or Akvavit or Akevitt: The spirit of Scandinavia, gin's Nordic cousin, snaps, it goes by many names around the world. Some even sails around the world before it's bottled. This episode explores some of the history, styles, and origins of the spirit, as well as some tasty tales of potato priests, black death, and drinking songs. Resources from this episode: Books: Certified Specialist of Spirits (CSS) Study Guide, Society of Wine Educators, Nickles, J. (2020) The Oxford Companion to Spirits and Cocktails [Kindle Edition], Wondrich, D & Rothbaum, N., (2022) Websites: Alcohol Professor: Three Exciting Aquavit Trends you Need to Know Now, English, C. (3 March 2023) https://www.alcoholprofessor.com/blog-posts/3-exciting-aquavit-trends Drink Fellows: Demystifying Aquavit, Bickford, M. (11 January 2023) https://drinkfellows.com/blogs/news/demystifying-aquavit English Grammar Lessons: See a Man About a Horse - Meaning, Origin, and Useage, Pearson (18 November 2021) https://english-grammar-lessons.com/see-a-man-about-a-horse-meaning/ Eur-Lex: Access to European Law, Regulation (EU) 2019/787 of the European Parliament and of the Council of 17 April 2019 on the definition, description, presentation and labelling of spirit drinks, the use of the names of spirit drinks in the presentation and labelling of other foodstuffs, the protection of geographical indications for spirit drinks, the use of ethyl alcohol and distillates of agricultural origin in alcoholic beverages, and repealing Regulation (EC) No 110/2008, Annex 1 [Categories of Spirit Drinks ], (24) Akvavit or aquavit https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019R0787-20240513&qid=1721068894716 Innherred: Aquavit History at Innherred: https://en.visitinnherred.com/aquavit-history-in-innherred/ Love to Know: Seven Aquavit Cocktails for a Nordic Spin on the Classics, Freeman, A. (8 February 2023) https://www.lovetoknow.com/food-drink/cocktails/aquavit-cocktails The Manual: A History of Brennivín Aquavit: The Black Death of Iceland, Fergus, J. (17 May 2017) https://www.themanual.com/food-and-drink/brennevin-aquavit-iceland/ Nordic Spirits: The History of Aquavit (nd) https://nordicspirits.com/en/history-aquavit Oslo: The Story of Norwegian Akevitt https://www.oslohd.com/about-norwegian-akevitt Scandinavia Standard: What is Aquavit? A Guide to the Scandinavian Spirit, Nielsen-Bobbit, J. (28 July 2020) https://www.scandinaviastandard.com/a-guide-to-scandinavian-aquavit/ Spritmuseum - Museum of Swedish Drinking Culture: The History of the Snaps Song https://spritmuseum.se/en/drinking-songs/ The Spruce Eats: What is Aquavit? Graham, C. (9 August 2022) https://www.thespruceeats.com/what-is-aquavit-4687051 Sunny Gandara: Aquavit - The history and tradition of the Norwegian ‘water of life', Gandara, S. (30 June 2018) https://sunnygandara.com/aquavit-the-history-and-tradition-of-the-norwegian-water-of-life/ Swedish Food: Swedish Drinking Songs (Svenska Snapsvisor), Duxbury, J. (n.d.) https://www.swedishfood.com/songs Glass in Session Episodes Relevant to this Episode: S4E6 | Got Wood? Talkin' bout Oak https://glassinsession.libsyn.com/s4e6-got-wood-talkin-bout-oak Glass in Session® swag mentioned in this show: https://www.teepublic.com/user/glass-in-session Glass in Session® is a registered trademark of Vino With Val, LLC. Music: “Write Your Story” by Joystock (Jamendo.com cc_Standard License, Jamendo S.A.)

love english spirit guide society llc council origin glass spirits iceland classics norwegian freeman booze pearson nordic scandinavia oak european parliament fergus annex bickford duxbury oxford companion aquavit european law gandara nickles scandanavia wine educators en txt akvavit man about standard license

Ars Boni 509 RenaturierungsVO (Prof. Dr. Karl Stöger)

Ars Boni

Play Episode Listen Later Jun 25, 2024 99:51

Wir sprechen mit Prof. Dr. Karl Stöger über die politischen Vorgänge zum Abstimmungsverhalten Österreichs im Rat zur RenaturierungsVO und ordnen diese rechtlich ein. Gegenstand sind insb. auch die unterschiedlichen Gutachten zu Rechtsfragen der Bindungswirkung von Länderstellungnahmen, zu §23d Abs 2 B-VG und zu § 5 Bundesministeriengesetz. Links: https://www.politico.eu/article/rogue-austria-environment-minister-leonore-gewessler-burns-bridges-save-eu-nature-restoration-law/ https://www.bmk.gv.at/service/publikationen/veroeffentlichungen-BVG.html https://info.bml.gv.at/im-fokus/studien-und-gutachten/rechtsgutachten-auslegung-von-paragraf-5-bundesministeriengesetz.html https://t.co/yaBjFIMq3o https://t.co/9Na4Se1TGi Art. 16 EUV: https://ris.bka.gv.at/eli/bgbl/iii/1999/85/A16/NOR40157434?Abfrage=Bundesnormen&Kundmachungsorgan=&Index=&Titel=EUV&Gesetzesnummer=&VonArtikel=16&BisArtikel=&VonParagraf=&BisParagraf=&VonAnlage=&BisAnlage=&Typ=&Kundmachungsnummer=&Unterzeichnungsdatum=&FassungVom=22.06.2024&VonInkrafttretedatum=&BisInkrafttretedatum=&VonAusserkrafttretedatum=&BisAusserkrafttretedatum=&NormabschnittnummerKombination=Und&ImRisSeitVonDatum=&ImRisSeitBisDatum=&ImRisSeit=Undefined&ResultPageSize=100&Suchworte=&Position=1&SkipToDocumentPage=true&ResultFunctionToken=a1911ace-1ab5-453d-b615-02111d81cc6f WVK, insb Art 46, 47: https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10000684 Art. 23d B-VG https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10000138 § 5 BMG, https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10000873 § 302 StGB https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10002296 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on nature restoration, COM/2022/304 final, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022PC0304 Abstimmung im Rat: https://www.linkedin.com/search/results/content/?keywords=gewessler%20anzeige&sid=)VZ&update=urn%3Ali%3Afs_updateV2%3A(urn%3Ali%3Aactivity%3A7209864332988370946%2CBLENDED_SEARCH_FEED%2CEMPTY%2CDEFAULT%2Cfalse) Anzeige § 302 StGB https://www.ots.at/presseaussendung/OTS_20240617_OTS0084/stocker-volkspartei-bringt-strafanzeige-wegen-amtsmissbrauch-gegen-gewessler-ein https://www.oe24.at/oesterreich/politik/das-ist-die-oevp-strafanzeige-gegen-gewessler/598363591#google_vignette

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AFNOR - How is a Notified Body designated?

National Security Law Today

Play Episode Listen Later Jun 18, 2024 33:10

If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned. Who is Thomas Lommatzsch? Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years' experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application to medical devices. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Thomas Lommatzsch Linkedin Profile: https://www.linkedin.com/in/thomas-lommatzsch/ AFNOR webpage: https://certification.afnor.org/qualite/marquage-ce-dispositifs-medicaux EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320 French competent authority ANSM: https://ansm.sante.fr/ JAT Joint Assessment: https://health.ec.europa.eu/document/download/b9d671f5-02d0-44b1-a207-b07aeb4ef931_en?filename=md_info_ja_mdr_en.pdf MDCG 2022-13 Designation, re-assessment and notification of conformity assessment Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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EP111 - ECON CON CONS

Alles voor Bitcoin

Play Episode Listen Later Mar 22, 2024 46:32

EP111 - Aflevering 111 gaat over de ECON wetgeving inzake unhosted wallets, en KYC, de richting van Europa, en we reviewen Brian Demint's "Parallel" boek + een kleine filosofische mijmering daarover. links: https://www.europarl.europa.eu/doceo/document/CJ12-OJ-2023-03-28-1_EN.html https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0420 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32019R0758 https://www.consilium.europa.eu/en/press/press-releases/2024/02/26/council-adopts-regulation-on-instant-payments/ https://www.cashmatters.org/blog/european-parliament-to-vote-on-cash-payment-limits https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0420 https://eur-lex.europa.eu/resource.html?uri=cellar:0a4db7d6-eace-11eb-93a8-01aa75ed71a1.0017.02/DOC_1&format=PDF VOTE: Committee on Economic and Monetary AffairsDraft : https://www.europarl.europa.eu/doceo/document/CJ12-AM-734118_EN.pdf Parallel (Brian E. De Mint ) https://www.amazon.com/Parallel-Bitcoin-Social-Brian-Mint-ebook/dp/B0CWQBCJNL

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The Data Market: The Price of Privacy with Alex Joel (Part 2)

Play Episode Listen Later Jan 9, 2024 34:10

To what extent do elected officials and lawmakers understand how data transmits the internet? This week, host Elisa is joined by Alex Joel of American University's Washington College of Law for the second half of their discussion on international data transmission and privacy. Alex sheds light on the concept of data localization, delves into the intricacies of Schrems cases I & II, and discusses how the rulings on these cases impact global data flows and national security. Alex Joel is a Scholar-in-Residence and Adjunct Professor at American University's Washington College of Law: https://www.wcl.american.edu/community/faculty/profile/ajoel/bio/ References: The CLOUD Act: https://epic.org/wp-content/uploads/privacy/cloud-act/cloud-act-text.pdf Schrems I: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62014CJ0362 Schrems II: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62018CJ0311 Charter of Fundamental Rights of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012P/TXT "Digital Repression Growing Globally, Threatening Freedoms." The National Intelligence Council: https://www.dni.gov/files/ODNI/documents/assessments/NIC-Declassified-Assessment-Digital-Repression-Growing-April2023.pdf "Global Trends 2040." The National Intelligence Council: https://www.dni.gov/files/ODNI/documents/assessments/GlobalTrends_2040.pdf E.O. 14086: https://www.govinfo.gov/content/pkg/FR-2022-10-14/pdf/2022-22531.pdf EU General Data Protection Regulation (GDPR): https://gdpr.eu/tag/gdpr/ Foreign Intelligence Surveillance Act (FISA) Section 702 Resource Page: https://www.fisa702resources.com/ The Fair Information Practice Principles: https://www.dhs.gov/sites/default/files/2023-08/Governing%20Privacy%20Policy%20-%20The%20Fair%20Information%20Principles-Framework%20for%20Privacy%20Policy%20at%20the%20Department%20of%20Homeland%20Security.pdf The Privacy Act of 1974: https://osc.gov/Pages/Privacy-Act.aspx#:~:text=The%20Privacy%20Act%20provides%20protections,relevant%2C%20timely%20or%20complete%3B%20and OECD Privacy Guidelines, 1980: https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0188

law data market european union price privacy residence adjunct professor scholar american university global trends washington college fundamental rights odni national intelligence council schrems joel part en txt

S05E02 Tendencias con el Observatorio

Despacho 42

Play Episode Listen Later Dec 21, 2023 72:07

Tradiciones de fin de año: nuestra charla anual con las personas del Observatorio de Tecnológico de (sí O:-)) los Estudios de Informática, Multimedia y Telecomunicación de la UOC. Hablamos con Josep Curto (01:54), Josep Jorba (12:16), Desiré Gómez (22:51), Paloma González (33:40), Toni Pérez (45:47) y Robert Clarisó (58:25) de lo que ha pasado en 2023 y de lo que pasará en 2024 en nuestro mundillo. Y no os perdáis los enlaces, que vienen cargaditos de información. Enlaces del podcast Recomendaciones de seguridad en migraciones cloud https://www.checkpoint.com/cyber-hub/cloud-security/what-is-cloud-migration/cloud-migration-security/ El phishing y la IA https://www.cnbc.com/2023/11/28/ai-like-chatgpt-is-creating-huge-increase-in-malicious-phishing-email.html Guerra tecnológica China - Estados Unidos https://www.realinstitutoelcano.org/en/analyses/the-us-china-technology-war-and-its-effects-on-europe/ El bloqueo de Estados Unidos a China y el desarrollo de chips RISC-V https://www.theregister.com/2023/11/07/proposed_restrictions_riscv/ EU AI ACT: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206 NIST AI RISK MANAGEMENT FRAMEWORK: https://www.nist.gov/itl/ai-risk-management-framework Awesome Responsible AI: https://github.com/AthenaCore/AwesomeResponsibleAI Resumen del acuerdo legal de la UE en materia de IA, Olivier Patel. https://pbs.twimg.com/media/GBIbUPQXsAAZlzh?format=jpg&name=4096x4096 Informe GEM 2023: Tecnología en la educación, UNESCO. https://unesdoc.unesco.org/ark:/48223/pf0000386165_spa/PDF/386165spa.pdf.multi Artículo "New to the job market? These 5 ‘soft' skills could give young workers an edge", CNBC, Goh Chiew Tong https://www.cnbc.com/2023/01/04/linkedins-top-5-soft-skills-you-should-start-building-on-right-now.html Gasto energético de los grandes datacenters, Joule, 2023/10/18, PDF, https://doi.org/10.1016/j.joule.2023.09.004 Refrigeración y gasto energético de los grandes datacenters: Joule, 2023/10/18, PDF, https://doi.org/10.1016/j.joule.2023.09.004 Rowan Atkinson sobre los problemas del coche eléctrico: https://www.theguardian.com/commentisfree/2023/jun/03/electric-vehicles-early-adopter-petrol-car-ev-environment-rowan-atkinson Baterías de estado sólido: https://www.carmagazine.co.uk/electric/solid-state-battery-ev/ Baterías de grafeno: https://www.abc.es/motor/motoreco/primera-bateria-grafeno-ideada-universidad-valencia-20230302022956-nt.html Vehículos de hidrógeno: https://www.theguardian.com/environment/2023/mar/07/hydrogen-clean-fuel-climate-crisis-explainer Microsoft Copilot se integra en Office 365 https://blogs.microsoft.com/blog/2023/03/16/introducing-microsoft-365-copilot-your-copilot-for-work/ Google Bard can now connect to your Google apps and services https://blog.google/products/bard/google-bard-new-features-update-sept-2023/ Inside Apple's Big Plan to Bring Generative AI to All Its Devices https://www.bloomberg.com/news/newsletters/2023-10-22/what-is-apple-doing-in-ai-revamping-siri-search-apple-music-and-other-apps-lo1ffr7p Introducing Dropbox Dash, AI-powered universal search, and Dropbox AI https://blog.dropbox.com/topics/product/introducing-AI-powered-tools Dropbox spooks users by sending data to OpenAI for AI search features https://arstechnica.com/information-technology/2023/12/dropbox-spooks-users-by-sending-data-to-openai-for-ai-search-features/ Generating Content and Profits: Examining the Potential Business Models of Generative AI https://www.nasdaq.com/articles/generating-content-and-profits%3A-examining-the-potential-business-models-of-generative-ai The economic potential of generative AI: The next productivity frontier https://www.mckinsey.com/capabilities/mckinsey-digital/our-insights/the-economic-potential-of-generative-ai-the-next-productivity-frontier#introduction Monopoly power is the elephant in the room in the AI debate https://www.techpolicy.press/monopoly-power-is-the-elephant-in-the-room-in-the-ai-debate/ The real story of the OpenAI debacle is the tyranny of big tech https://www.theguardian.com/commentisfree/2023/nov/27/openai-microsoft-big-tech-monopoly Google's AI technology could further entrench online search monopoly: lawmakers https://nypost.com/2023/10/29/business/googles-ai-technology-could-entrench-online-search-monopoly/ Microsoft CEO warns of ‘nightmare' future for AI if Google's search dominance continues https://edition.cnn.com/2023/10/02/tech/microsoft-warning-google-search-monopoly/index.html A closer look at the top 5 open source LLMs https://blog.n8n.io/open-source-llm/ 5 easy ways to run a LLM locally https://www.infoworld.com/article/3705035/5-easy-ways-to-run-an-llm-locally.html

Soltar en vacaciones y cómo leer etiquetas de cosméticos. Ep. 51

Cosmética de Trincheras

Play Episode Listen Later Aug 22, 2023 25:59

En este episodio te enseño a entender el listado de ingredientes de los productos cosméticos y te cuento algo que he descubierto este año quedándome en casa por vacaciones

ticos leer vacaciones soltar cosm receta etiquetas en txt

Medical Device News - July 2023 Regulatory Update

social media uk european union risk healthcare software switzerland regulatory misunderstanding classification medical devices regulatory affairs importers classifying qara en txt

Play Episode Listen Later Jul 4, 2023 23:41

Sponsor Medboard https://www.medboard.com/ EU Annex XVI transition EU MDR Domino is making more falls. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194New Timeline Until 31 December 2029 Cybersecurity and privacy in AI Medical imaging diagnosis https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosisANSM wants barcode on Field Safety Notice Why not all the other countries https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes AEMPS clinical trials involving drugs and medical devices What are the rules if your device is not CE marked https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/ Switzerland Medicinal products with a medical device component rules for combination products https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html UK Implementation of the Future Regulations Should you focus on UKCA? https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations eQMS Do you need an eQMS? Let me introduce Smarteye: https://smart-eye.io So contact info@scube-technologies.com to get a demo USA Premarket notification for Software What is different with Premarket submission for hardware https://www.fda.gov/media/153781/download Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023 Australia TGA Use of market authorisation evidence Comparable overseas regulators https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds Malaysia Malaysia rules on EU MDR extension Letter needed https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html Saudi Arabia Saudi Arabia Webinars AI and Classification are on the spotlightArtificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535 Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536 Authorized Representative Do you need an Authorized Representative info@easymedicaldevice.com Service: easymedicaldevice.com Podcast Nostalgia: Podcast Nostalgia What was presented in June. The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/ How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/ What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/ Easy Medical Device Support Thanks for your support info@easymedicaldevice.com If you need us to perform your own Regulatory Update, don't hesitate to contact us at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particuarly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

(81) Keine Angst vor Künstlicher Intelligenz?

Synapsen. Ein Wissenschaftspodcast von NDR Info

Play Episode Listen Later Jun 23, 2023 69:00

Ethiker*innen blicken mit Sorge auf die rasante Entwicklung in der KI-Forschung - in manchen Bereichen aber auch mit Gelassenheit. Denn man muss zwischen verschiedenen Dimensionen von künstlicher Intelligenz unterscheiden, und die sind mit ganz unterschiedlichen Risiken behaftet. Bislang regulieren KI-Entwickler sich höchstens selbst, und das soll zunächst auch so bleiben. Doch im Alltag steckt viel mehr KI, als das vielen bewusst ist. Deshalb mahnt die Forschung eine Regulation an, wie die EU sie jetzt auf den Weg bringen will. Das gilt auch für das menschliche Feedback, mit dem Anwendungen und Algorithmen optimiert werden sollen - und hier besteht noch immer eine regulatorische Lücke. Frederik Schulz-Greve hat mit Wissenschaftler*innen gesprochen, die sich mit den ethischen Grundlagen und Folgen der Anwendung von Künstlicher Intelligenz beschäftigen. Im Gespräch mit Host Lucie Kluth erklärt er, wo Potenziale liegen, warum Hochschulen auch angstbefreit an den Umgang mit ChatGPT herangehen könnten, wie Crowdworker Feedback geben und was all das zum Beispiel mit der Entwicklung von Antibiotika zu tun hat. Die Hintergrundinformationen: Stellungnahme des Deutschen Ethikrats zum Thema Künstliche Intelligenz (KI): Deutscher Ethikrat. Mensch und Maschine – Herausforderungen durch Künstliche Intelligenz. https://www.ethikrat.org/publikationen/publikationsdetail/?tx_wwt3shop_detail%5Bproduct%5D=168&tx_wwt3shop_detail%5Baction%5D=index&tx_wwt3shop_detail%5Bcontroller%5D=Products&cHash=2832da3eabd1b566403727910cee637e [aufgerufen am 22. Juni 2023] Nvidia über Wettervorhersage mithilfe von KI: Nvidia. Stormy Weather? Scientist Sharpens Forecasts With AI. Nvidia Blog. https://blogs.nvidia.com/blog/2022/11/01/ai-weather-forecasts-durran/ [aufgerufen am 22. Juni 2023] Studie über Bauchspeicheldrüsenkrebsforschung mithilfe von KI: Placido D et al. A deep learning algorithm to predict risk of pancreatic cancer from disease trajectories. Nature Medicine. 2023;29: 1113-1122. https://doi.org/10.1038/s41591-023-02332-5 Informationen zur Häufigkeit von Bauchspeicheldrüsenkrebs in Deutschland: Zentrum für Krebsregisterdaten. Bauchspeicheldrüsenkrebs (Pankreaskarzinom). https://www.krebsdaten.de/Krebs/DE/Content/Krebsarten/Bauchspeicheldruesenkrebs/bauchspeicheldruesenkrebs_node.html [aufgerufen am 22. Juni 2023] Studie zur Krankenhauskeimforschung mithilfe von KI: Liu G et al. Deep learning-guided discovery of an antibiotic targeting Acinetobacter baumannii. Nature Chemical Biology. 2023. https://doi.org/10.1038/s41589-023-01349-8 Informationen über die Projekte von Professor Bela Gipp: https://gipplab.org/projects/ [aufgerufen am 22. Juni 2023] Deutschlandfunkbeitrag über KI in chinesischen Schulen: DLF: Alles unter Kontrolle - Chinas intelligenter Schule entgeht nichts. https://www.deutschlandfunk.de/alles-unter-kontrolle-chinas-intelligenter-schule-entgeht-102.html [aufgerufen am 22. Juni 2023] Studie des DIW zu KI im Arbeitsumfeld: Giering O et al. Künstliche Intelligenz in Deutschland: Erwerbstätige wissen oft nicht, dass sie mit KI-basierten Systemen arbeiten. DIW Wochenbericht 2021;48. https://www.diw.de/documents/publikationen/73/diw_01.c.830715.de/21-48-1.pdf [aufgerufen am 22. Juni 2023] Nicht begutachtete Analyse der Entwickler:innen von ChatGPT zu den Auswirkungen von KI auf den Arbeitsmarkt: Eloundou T et al. GPTs are GPTs: An Early Look at the Labor Market Impact Potential of Large Language Models. Working paper; 2023. https://arxiv.org/pdf/2303.10130.pdf [aufgerufen am 22. Juni 2023] Analyse von Goldman Sachs zu den Auswirkungen von KI auf den Arbeitsmarkt: Hatzius J et al: Global Economics Analyst - The Potentially Large Effects of Artificial Intelligence on Economic Growth. Goldman Sachs – Economics Research; 2023. https://www.gspublishing.com/content/research/en/reports/2023/03/27/d64e052b-0f6e-45d7-967b-d7be35fabd16.html [aufgerufen am 22. Juni 2023] Studie zu den Effekten von KI auf den chinesischen Arbeitsmarkt: Zhou G et al. The effect of artificial intelligence on China's labor market. China Economic Journal. 2020; 13(1), 24-41. https://doi.org/10.1080/17538963.2019.1681201 Weitere Informationen zu Auswirkungen von KI auf den Arbeitsmarkt: KI und Arbeitsmarkt: Welche Effekte sind zu erwarten? Science Media Center. https://www.sciencemediacenter.de/alle-angebote/science-response/details/news/ki-und-arbeitsmarkt-welche-effekte-sind-zu-erwarten/[aufgerufen am 22. Juni 2023] EU-KI-Verordnung - Gesetzesvorschlag der EU-Kommission: EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206 [aufgerufen am 22. Juni 2023] Informationen zur KI-Verordnung für Unternehmen von einer Anwaltskanzlei: Die KI-Verordnung kommt. Leitfaden für Unternehmen. Schürmann Rosenthal Dreyer. https://www.srd-rechtsanwaelte.de/ki-verordnung/ [aufgerufen am 22. Juni 2023] Informationen über geheilten Querschnittsgelähmten: Lorach H et al. Walking naturally after spinal cord injury using a brain-spine interface. Nature. 2023;618: 126-133. https://doi.org/10.1038/s41586-023-06094-5 Studie von Paul Rainey zum Thema KI und Evolution: Rainey P. Major evolutionary transitions in individuality between humans and AI. Philosophical Transactions of the Royal Society B – Biological Sciences. 2023;378. https://doi.org/10.1098/rstb.2021.0408

(81) Keine Angst vor Künstlicher Intelligenz?

NDR Info - Logo - Das Wissenschaftsmagazin

Play Episode Listen Later Jun 23, 2023 69:00

Ethiker*innen blicken mit Sorge auf die rasante Entwicklung in der KI-Forschung - in manchen Bereichen aber auch mit Gelassenheit. Denn man muss zwischen verschiedenen Dimensionen von künstlicher Intelligenz unterscheiden, und die sind mit ganz unterschiedlichen Risiken behaftet. Bislang regulieren KI-Entwickler sich höchstens selbst, und das soll zunächst auch so bleiben. Doch im Alltag steckt viel mehr KI, als das vielen bewusst ist. Deshalb mahnt die Forschung eine Regulation an, wie die EU sie jetzt auf den Weg bringen will. Das gilt auch für das menschliche Feedback, mit dem Anwendungen und Algorithmen optimiert werden sollen - und hier besteht noch immer eine regulatorische Lücke. Frederik Schulz-Greve hat mit Wissenschaftler*innen gesprochen, die sich mit den ethischen Grundlagen und Folgen der Anwendung von Künstlicher Intelligenz beschäftigen. Im Gespräch mit Host Lucie Kluth erklärt er, wo Potenziale liegen, warum Hochschulen auch angstbefreit an den Umgang mit ChatGPT herangehen könnten, wie Crowdworker Feedback geben und was all das zum Beispiel mit der Entwicklung von Antibiotika zu tun hat. Die Hintergrundinformationen: Stellungnahme des Deutschen Ethikrats zum Thema Künstliche Intelligenz (KI): Deutscher Ethikrat. Mensch und Maschine – Herausforderungen durch Künstliche Intelligenz. https://www.ethikrat.org/publikationen/publikationsdetail/?tx_wwt3shop_detail%5Bproduct%5D=168&tx_wwt3shop_detail%5Baction%5D=index&tx_wwt3shop_detail%5Bcontroller%5D=Products&cHash=2832da3eabd1b566403727910cee637e [aufgerufen am 22. Juni 2023] Nvidia über Wettervorhersage mithilfe von KI: Nvidia. Stormy Weather? Scientist Sharpens Forecasts With AI. Nvidia Blog. https://blogs.nvidia.com/blog/2022/11/01/ai-weather-forecasts-durran/ [aufgerufen am 22. Juni 2023] Studie über Bauchspeicheldrüsenkrebsforschung mithilfe von KI: Placido D et al. A deep learning algorithm to predict risk of pancreatic cancer from disease trajectories. Nature Medicine. 2023;29: 1113-1122. https://doi.org/10.1038/s41591-023-02332-5 Informationen zur Häufigkeit von Bauchspeicheldrüsenkrebs in Deutschland: Zentrum für Krebsregisterdaten. Bauchspeicheldrüsenkrebs (Pankreaskarzinom). https://www.krebsdaten.de/Krebs/DE/Content/Krebsarten/Bauchspeicheldruesenkrebs/bauchspeicheldruesenkrebs_node.html [aufgerufen am 22. Juni 2023] Studie zur Krankenhauskeimforschung mithilfe von KI: Liu G et al. Deep learning-guided discovery of an antibiotic targeting Acinetobacter baumannii. Nature Chemical Biology. 2023. https://doi.org/10.1038/s41589-023-01349-8 Informationen über die Projekte von Professor Bela Gipp: https://gipplab.org/projects/ [aufgerufen am 22. Juni 2023] Deutschlandfunkbeitrag über KI in chinesischen Schulen: DLF: Alles unter Kontrolle - Chinas intelligenter Schule entgeht nichts. https://www.deutschlandfunk.de/alles-unter-kontrolle-chinas-intelligenter-schule-entgeht-102.html [aufgerufen am 22. Juni 2023] Studie des DIW zu KI im Arbeitsumfeld: Giering O et al. Künstliche Intelligenz in Deutschland: Erwerbstätige wissen oft nicht, dass sie mit KI-basierten Systemen arbeiten. DIW Wochenbericht 2021;48. https://www.diw.de/documents/publikationen/73/diw_01.c.830715.de/21-48-1.pdf [aufgerufen am 22. Juni 2023] Nicht begutachtete Analyse der Entwickler:innen von ChatGPT zu den Auswirkungen von KI auf den Arbeitsmarkt: Eloundou T et al. GPTs are GPTs: An Early Look at the Labor Market Impact Potential of Large Language Models. Working paper; 2023. https://arxiv.org/pdf/2303.10130.pdf [aufgerufen am 22. Juni 2023] Analyse von Goldman Sachs zu den Auswirkungen von KI auf den Arbeitsmarkt: Hatzius J et al: Global Economics Analyst - The Potentially Large Effects of Artificial Intelligence on Economic Growth. Goldman Sachs – Economics Research; 2023. https://www.gspublishing.com/content/research/en/reports/2023/03/27/d64e052b-0f6e-45d7-967b-d7be35fabd16.html [aufgerufen am 22. Juni 2023] Studie zu den Effekten von KI auf den chinesischen Arbeitsmarkt: Zhou G et al. The effect of artificial intelligence on China's labor market. China Economic Journal. 2020; 13(1), 24-41. https://doi.org/10.1080/17538963.2019.1681201 Weitere Informationen zu Auswirkungen von KI auf den Arbeitsmarkt: KI und Arbeitsmarkt: Welche Effekte sind zu erwarten? Science Media Center. https://www.sciencemediacenter.de/alle-angebote/science-response/details/news/ki-und-arbeitsmarkt-welche-effekte-sind-zu-erwarten/[aufgerufen am 22. Juni 2023] EU-KI-Verordnung - Gesetzesvorschlag der EU-Kommission: EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206 [aufgerufen am 22. Juni 2023] Informationen zur KI-Verordnung für Unternehmen von einer Anwaltskanzlei: Die KI-Verordnung kommt. Leitfaden für Unternehmen. Schürmann Rosenthal Dreyer. https://www.srd-rechtsanwaelte.de/ki-verordnung/ [aufgerufen am 22. Juni 2023] Informationen über geheilten Querschnittsgelähmten: Lorach H et al. Walking naturally after spinal cord injury using a brain-spine interface. Nature. 2023;618: 126-133. https://doi.org/10.1038/s41586-023-06094-5 Studie von Paul Rainey zum Thema KI und Evolution: Rainey P. Major evolutionary transitions in individuality between humans and AI. Philosophical Transactions of the Royal Society B – Biological Sciences. 2023;378. https://doi.org/10.1098/rstb.2021.0408

The great misunderstanding of EU MDR amendments

Play Episode Listen Later Jun 13, 2023 42:53

Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer some frequently asked questions from people. As you may see on the title there are some great misunderstandings, and the objective of today is to clear that out. For that I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on EU MDR extension. Who is Florian Tolkmitt? Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance and risk management and he is also assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, that works on an open-source data model for Technical Documentation. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: EU MDR extension: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf Team NB Notified Body confirmation letter: https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-NB-ConfirmationLetterEU2023-607-20230503.docx Florian Tolkmitt Linkedin : https://www.linkedin.com/in/floriantolkmitt/ Pro-Liance company Site: https://pro-liance.com/ EU 2023/607: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607 Podcast episode EU extension with Erik Vollebregt: https://podcast.easymedicaldevice.com/211-2/ LinkedIn Company: https://www.linkedin.com/company/pro-liance/ Social Media to follow: Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Medical Device News -June 2023 regulatory update

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Play Episode Listen Later Jun 8, 2023 30:49

Sponsor MedBoard: www.medboard.com EUROPE Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf EU MDR and IVDR consolidated versions EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320 EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320 Confirmation letter: EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054 EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262 Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/ Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices Training: Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26 Switzerland Incident reporting Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf United Kingdom New tutorial videos MHRA "How to register medical devices": https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system   ROW Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device        : https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/ Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/ Saudi Arabia Webinar: Explain The Essential Principles of Safety and Performance for Medical Devices: https://www.sfda.gov.sa/en/workshop/88451 Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450 Podcast Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/ Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/ Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/ Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/ Ask Easy Medical Device . We can help you Contact at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Queer Youth Work with Vika Matuzaitė, season 3, episode 6

Talking Youth Work

Play Episode Listen Later May 24, 2023 48:32

Hello dear listeners, In this episode, we had the privilege of speaking with Vika Matuzaitė, a non-formal education trainer and facilitator, who enlightened us about the concept of Queer Youth and how youth workers can support Queer young people. In today's world, there can be significant confusion surrounding this topic, where gender, identity, and sexuality are often erroneously treated as interchangeable terms. It also happens with other terminology. While the LGBTQI+ acronym encompasses certain aspects, the term ‘queer' transcends gender and sexuality, encompassing a broader spectrum. Unfortunately, queer young individuals encounter numerous challenges stemming from the lack of understanding they often face, particularly within their own families and social circles. Society bombards them with messages suggesting that deviating from the norm is ‘wrong,' leaving them feeling inadequate, isolated, and excluded. Tragically, the queer population faces a higher risk of homelessness, addiction, and suicide. Therefore, it is crucial for everyone to gain a deeper comprehension of diversity and actively embrace the unique challenges faced by queer youth from a young age. Vika shared a poignant story about a 16-year-old who confided in her, expressing gratitude for being the first person with whom they could openly discuss their experiences of the world. This example forces us to reflect on the essential role each of us plays in creating inclusive spaces where individuals can authentically express themselves and find acceptance for their experiences. As someone's grandmother wisely said, ‘We need create the space where people matter more than opinions.' We encourage you to listen to this enlightening conversation and share your thoughts with us. The EU LGBTI strategy: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0698 Youth worker's resource: https://cara-friend.org.uk/wp-content/uploads/2018/09/22307-CaraFriend-Youth-Worker-Booklet-LGBTQ-Final-screen.pdf Working with kids with the topics of gender and sexuality (Compasito companion): http://ifm-sei.org/educational-resources-2/rainbow-resources/ A kick-start reading about queer theory: https://iconbooks.com/ib-title/queer-a-graphic-history/

Что нового в мире Python за апрель

Moscow Python: подкаст о Python на русском

Play Episode Listen Later May 5, 2023 58:36

Новый выпуск посвятили актуальным новостям за апрель 2023 года в мире Python. Ниже оставили ссылки на все материалы этого подкаста. • статья от Python Software Foundation - https://pyfound.blogspot.com/2023/04/the-eus-proposed-cra-law-may-have.html • европейские акты: - Cyber Resilience Act - https://digital-strategy.ec.europa.eu/en/library/cyber-resilience-act - Product Liability Act - https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022PC0495 • релиз urllib3 2.0 - https://sethmlarson.dev/urllib3-2.0.0 • PyPI анонсировали поддержку trusted publisher - https://blog.pypi.org/posts/2023-04-20-introducing-trusted-publishers/ • менеджер пакетов от создателя Flask - https://github.com/mitsuhiko/rye • Debian больше не даст делать pip install глобально - https://salsa.debian.org/python-team/packages/python-pip/-/blob/master/debian/NEWS • лямбды и Python 3.10 в AWS - https://aws.amazon.com/ru/blogs/compute/python-3-10-runtime-now-available-in-aws-lambda/ • статья про популярность языков по количесвту pull реквестов на Github - https://lemire.me/blog/2023/04/07/programming-language-popularity-by-github-pull-requests/ и https://madnight.github.io/githut/#/pull_requests/2023/1 • курсы Learn Python - https://learn.python.ru/ • конференция Moscow Python - https://conf.python.ru/moscow/2023 • канал Миши "Хитрый Питон" - https://t.me/tricky_python Ведущие: Михаил Корнеев и Григорий Петров CFP Moscow Python Conf https://cfp.conf.python.ru Все выпуски: https://podcast.python.ru Митапы MoscowPython: https://moscowpython.ru Курс Learn Python: https://learn.python.ru/

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Ars Boni 397 European Media Freedom (Act) (Marta Cantero Gamito)

Ars Boni

Play Episode Listen Later Apr 19, 2023 53:04

We are talking with Marta Cantero Gamito on the (proposed) European Media Freedom Act. Marta is research fellow at the European University Institute in Florence and associate professor in IT law at the University of Tartu (IT Law Programme) since 2018. The talk will be based on Marta's article: "The European Media Freedom Act (EMFA) as meta-regulation". The EMFA, according to the European Commission, aims to introduce "sets of rules to protect media pluralism and independence in the EU. The proposed Regulation includes, among others, safeguards against political interference in editorial decisions and against surveillance." Links: https://www.eui.eu/people?id=marta-cantero-gamito-1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0457 https://doi.org/10.1016/j.clsr.2023.105799 https://ec.europa.eu/commission/presscorner/detail/en/ip_22_5504

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#332 A Python, a Slurpee, and Some Chaos

Python Bytes

Play Episode Listen Later Apr 18, 2023 36:56

Watch on YouTube About the show Sponsored by InfluxDB from Influxdata. Connect with the hosts Michael: @mkennedy@fosstodon.org Brian: @brianokken@fosstodon.org Show: @pythonbytes@fosstodon.org Join us on YouTube at pythonbytes.fm/live to be part of the audience. Usually Tuesdays at 11am PT. Older video versions available there too. Brian #1: huak - A Python package manager written in Rust. Inspired by Cargo Suggested by Owen Tons of workflows activate - activate a virtual environment add add a dependency to a project pip install it into your virtual environment, and add it to the dependency list in pyproject.toml test - run pytest update update dependencies lint - run ruff, installing it first if necessary fix - autofix fixable lint conflicts build - build wheel in isolated virtual environment using hatchling Honestly I was considering building my own workflow tool, but this is darned close to what I want. Even though it's still “in an experimental state”. There are rough edges (ruff edges, get it), but still, way cool. I just don't know how to pronounce it. Is it like “walk”, or more like “whack”? Michael #2: PSF expresses concerns about a proposed EU law that may make it impossible to continue providing Python and PyPI to the European public After reviewing the proposed Cyber Resilience Act and Product Liability Act, the PSF has found issues that put the mission of our organization and the health of the open-source software community at risk. As currently written, the authors of open-source components might bear legal and financial responsibility for the way their components are applied in someone else's commercial product. The risk of huge potential costs would make it impossible in practice for us to continue to provide Python and PyPI to the European public. Brian #3: ChaosToolkit Suggested by the maintainer, Sylvain Hellegouarch Declare and store your Chaos Engineering experiments as JSON/YAML files so you can collaborate and orchestrate them as any other piece of code. Extensible through an Open API Can be automated in CI/CD pipeline Michael #4: PEP 711 – PyBI: a standard format for distributing Python Binaries “Like wheels, but instead of a pre-built python package, it's a pre-built python interpreter” Joke: It's the effort that counts

Dovrei passare al MOTORE elettrico? Guardiamo i dati

La Miniera

Play Episode Listen Later Apr 14, 2023 20:29

⬇⬇⬇APRIMI⬇⬇ Abbonati qui: https://www.youtube.com/economiaitalia/join https://www.patreon.com/join/EconomiaItalia? Dovrei passare al MOTORE elettrico? Guardiamo i dati Sono appena tornato dalle mie vacanze e ho riflettuto sulla possibilità di passare all'auto elettrica. Sì, lo so, sembra una di quelle cose da "hipster" che si preoccupano solo dell'ambiente, ma voglio solo fare la cosa giusta! La mia preoccupazione principale riguardava l'autonomia, ma sembra che i progressi siano stati fatti in questo campo. Tuttavia, il mio problema è che spesso faccio viaggi lunghi e non voglio rimanere bloccato lungo la strada senza una colonnina di ricarica! Ma sembra che le stazioni di ricarica stiano crescendo rapidamente, quindi forse dovrei dar loro un'altra chance. In ogni caso, credo che aspetterò ancora un po' prima di passare all'auto elettrica, ma sembra che stiamo andando nella giusta direzione. FONTI: https://hannahritchie.substack.com/p/public-ev-chargers https://hannahritchie.substack.com/p/electric-car-range https://hannahritchie.substack.com/p/ev-battery-costs#footnote-4-93415192 https://ourworldindata.org/battery-price-decline https://theicct.org/wp-content/uploads/2021/12/ev-us-market-growth-cities-sept21_0.pdf https://www.iea.org/data-and-statistics/data-tools/global-ev-data-explorer https://op.europa.eu/webpub/eca/special-reports/electrical-recharging-5-2021/en/#box2 https://www.motus-e.org/wp-content/uploads/2023/02/Infografica-ricarica-auto-elettriche-scaled.jpg https://www.motus-e.org/wp-content/uploads/2023/02/Report-Infrastrutture-di-ricarica-a-uso-pubblico-Italia-quarta-edizione.pdf https://www.autostrade.it/it/aree-di-servizio1?op=adsNome&nome= https://annuario.isprambiente.it/sys_ind/261 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014L0094-20211112 https://theicct.org/wp-content/uploads/2021/06/EV_charging_guide_03162020.pdf Qui per segnalare temi: https://tellonym.me/dr.elegantia Podcast (su tutte le piattaforme): https://www.spreaker.com/show/dr-elegantia-podcast COME SOSTENERCI: Il nostro nuovo libro sull'economia: Guida Terrestre per Autoeconomisti https://www.poliniani.com/product-page/guida-terrestre link acquisto Amazon: https://amzn.to/36XTXs8 Acquistando le nostre T-shirt dedicate ai dati stampate in Serigrafia Artigianale con passione e orgoglio dai detenuti del Carcere Lorusso e Cutugno di Torino https://bit.ly/3zNsdkd e HTTPS://urly.it/3nga1 Guida al VOTO 2022: https://amzn.to/3KflXHd DonazionI Paypal: https://paypal.me/appuntiUAB Vuoi sostenermi ma non sborsare nemmeno un euro? Usa questo link per per il tuo prossimo acquisto su Amazon: https://amzn.to/2JGRyGT Qui trovi i libri che consiglio per iniziare a capirne di più sull'economia: https://www.youtube.com/watch?v=uEaIk8wQ3z8 È tornata l'offerta di Buddybank. 25€ per ogni conto aperto. Io ho un conto buddybank da oltre un anno. Devo dire super top. Zero commissioni sui bonifici. No canone. Inserisci il codice E7B9B0 in fase di richiesta di apertura conto corrente buddybank. Scarica l'app qui: https://app.adjust.com/qpkbnd2 Dove ci trovi: https://www.umbertobertonelli.it/info/ https://linktr.ee/economiaitalia La mia postazione: Logitech streamcam https://amzn.to/3HR6xq0 Luci https://amzn.to/3n6qtgP Shure MV7https://amzn.to/3HRh7k1 Asta https://amzn.to/3HSRvzY #economiaitalia #drelegantia #economia

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Dovrei passare al MOTORE elettrico? Guardiamo i dati

Dr.Elegantia podcast

Play Episode Listen Later Apr 14, 2023 20:29

⬇⬇⬇APRIMI⬇⬇ Abbonati qui: https://www.youtube.com/economiaitalia/join https://www.patreon.com/join/EconomiaItalia? Dovrei passare al MOTORE elettrico? Guardiamo i dati Sono appena tornato dalle mie vacanze e ho riflettuto sulla possibilità di passare all'auto elettrica. Sì, lo so, sembra una di quelle cose da "hipster" che si preoccupano solo dell'ambiente, ma voglio solo fare la cosa giusta! La mia preoccupazione principale riguardava l'autonomia, ma sembra che i progressi siano stati fatti in questo campo. Tuttavia, il mio problema è che spesso faccio viaggi lunghi e non voglio rimanere bloccato lungo la strada senza una colonnina di ricarica! Ma sembra che le stazioni di ricarica stiano crescendo rapidamente, quindi forse dovrei dar loro un'altra chance. In ogni caso, credo che aspetterò ancora un po' prima di passare all'auto elettrica, ma sembra che stiamo andando nella giusta direzione. FONTI: https://hannahritchie.substack.com/p/public-ev-chargers https://hannahritchie.substack.com/p/electric-car-range https://hannahritchie.substack.com/p/ev-battery-costs#footnote-4-93415192 https://ourworldindata.org/battery-price-decline https://theicct.org/wp-content/uploads/2021/12/ev-us-market-growth-cities-sept21_0.pdf https://www.iea.org/data-and-statistics/data-tools/global-ev-data-explorer https://op.europa.eu/webpub/eca/special-reports/electrical-recharging-5-2021/en/#box2 https://www.motus-e.org/wp-content/uploads/2023/02/Infografica-ricarica-auto-elettriche-scaled.jpg https://www.motus-e.org/wp-content/uploads/2023/02/Report-Infrastrutture-di-ricarica-a-uso-pubblico-Italia-quarta-edizione.pdf https://www.autostrade.it/it/aree-di-servizio1?op=adsNome&nome= https://annuario.isprambiente.it/sys_ind/261 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014L0094-20211112 https://theicct.org/wp-content/uploads/2021/06/EV_charging_guide_03162020.pdf Qui per segnalare temi: https://tellonym.me/dr.elegantia Podcast (su tutte le piattaforme): https://www.spreaker.com/show/dr-elegantia-podcast COME SOSTENERCI: Il nostro nuovo libro sull'economia: Guida Terrestre per Autoeconomisti https://www.poliniani.com/product-page/guida-terrestre link acquisto Amazon: https://amzn.to/36XTXs8 Acquistando le nostre T-shirt dedicate ai dati stampate in Serigrafia Artigianale con passione e orgoglio dai detenuti del Carcere Lorusso e Cutugno di Torino https://bit.ly/3zNsdkd e HTTPS://urly.it/3nga1 Guida al VOTO 2022: https://amzn.to/3KflXHd DonazionI Paypal: https://paypal.me/appuntiUAB Vuoi sostenermi ma non sborsare nemmeno un euro? Usa questo link per per il tuo prossimo acquisto su Amazon: https://amzn.to/2JGRyGT Qui trovi i libri che consiglio per iniziare a capirne di più sull'economia: https://www.youtube.com/watch?v=uEaIk8wQ3z8 È tornata l'offerta di Buddybank. 25€ per ogni conto aperto. Io ho un conto buddybank da oltre un anno. Devo dire super top. Zero commissioni sui bonifici. No canone. Inserisci il codice E7B9B0 in fase di richiesta di apertura conto corrente buddybank. Scarica l'app qui: https://app.adjust.com/qpkbnd2 Dove ci trovi: https://www.umbertobertonelli.it/info/ https://linktr.ee/economiaitalia La mia postazione: Logitech streamcam https://amzn.to/3HR6xq0 Luci https://amzn.to/3n6qtgP Shure MV7https://amzn.to/3HRh7k1 Asta https://amzn.to/3HSRvzY #economiaitalia #drelegantia #economiaDiventa un supporter di questo podcast: https://www.spreaker.com/podcast/dr-elegantia-podcast--5692498/support.

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EU will Work Life Balance von ALLEN kontrollieren (+1.000 Punkte!)

Steuerrechtskanzlei LedererLaw

Play Episode Listen Later Apr 7, 2023 8:25

EU Kommission will eine Berichtspflicht für Work Life Balance in den Firmen. Plus: Die Firmen sollen 1.000 Punkte über die Mitarbeiter dokumentieren und berichten. Verwalten wir uns zu Tode? Die Antworten verrate ich heute. Sei dein eigener Anwalt! Hol dir dein Rechtsdokument zum Umgang mit Finanzamt und Behörden auf

Rum: King of Booty? | S12E4

On Tech Ethics with CITI Program

Play Episode Listen Later Feb 24, 2023 43:49

Exploring the world of rum and rum around the world: history, places, people, and the etymology of the word booty ... because pirates. The Moghuls (?!) make a surprise appearance, we talk Navy rum rations, and Chat GPT lays a rum history "masterpiece" on us. Resources from this episode: Books: Certified Specialist of Spirits (CSS) Study Guide (Society of Wine Educators), Nickles, J., (2020) The Oxford Companion to Spirits and Cocktails [Kindle Edition], Wondrich, D & Rothbaum, N., (2022) Rum, Broom, D. (2003) Websites: Cocktail Wonk: Setting the Record Straight on British Navy Rum, Pietrek, M. (5 December 2019) https://cocktailwonk.com/2019/12/setting-record-straight-british-navy-rum.html Code of Federal Regulations: 27 CFR 5.147 Rum (2023) https://www.ecfr.gov/current/title-27/chapter-I/subchapter-A/part-5/subpart-I/section-5.147 Drum: The Rum War Rages - Bacardi insists it's Havana Club forever Cuban despite criticism, Smiley, M. (8 January 2018) https://www.thedrum.com/news/2018/01/08/the-rum-war-rages-bacardi-insists-its-havana-club-forever-cuban-despite-criticism El Dorado Rum: [video] https://theeldoradorum.com Eur-Lex Annex 1: Categories of Spirit Drinks - 1. Rum (2019) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R0787&qid=1676747286152 Got Rum Magazine: Pierino, M. (2023) https://www.gotrum.com Inside the Cask: The Distilleries and Rum Manufacturers of Guadeloupe, de Almeida, A. (7 June 2022) https://insidethecask.com/2022/06/07/the-distilleries-and-rum-manufacturers-of-guadeloupe/ Online Etymology Dictionary: Booty https://www.etymonline.com/search?q=booty Robb Report: The Rum the British navy Once Rationed to Sailors is Now Highly Coveted - and Surprisingly Good, Sachs, T. (31 July 2020) https://robbreport.com/food-drink/spirits/black-tot-rum-british-navy-ration-for-sale-2939203/ Spirits Business: Bacardi Sues USPTO over Havana Club Trademark, Carruthers, N. (5 January 2022) https://www.thespiritsbusiness.com/2022/01/bacardi-sues-uspto-over-havana-club-trademark/ Merriam-Webster: World History - Looking at ‘Booty' (the word) https://www.merriam-webster.com/words-at-play/booty-word-history Related or Referenced Glass in Session® Episodes: S3E2: Gin Revival https://glassinsession.libsyn.com/s3e2-gin-revival S4E6: Got Wood? Talkin' bout Oak https://glassinsession.libsyn.com/s4e6-got-wood-talkin-bout-oak S7E4: Booze Riots and Rebellions Part 2: Rum: https://glassinsession.libsyn.com/size/5/?search=Rum S8E3: Once Upon a Wine Grape in Afghanistan https://glassinsession.libsyn.com/s8e3-once-upon-a-wine-grape-in-afghanistan S9E2: Whisky, Burns Night, and … Beerhenge? https://glassinsession.libsyn.com/s9e2-whisky-burns-night-and-beerhenge S12E3: Madeira Primer https://glassinsession.libsyn.com/madeira-primer-s12e3 Glass in Session® swag mentioned in this show: https://www.teepublic.com/user/glass-in-session Music: Intro/Outro Theme: “Write Your Story” by Joystock (Jamendo.com cc_Standard License, Jamendo S.A.) Background beat for Chat GPT Rap: “Hip Hop Beat” by Coolrealistic (Pixabay) Glass in Session® is a registered trademark of Vino With Val, LLC.

Artificial Intelligence in Human Subjects Research

Play Episode Listen Later Jan 24, 2023 24:03

Covers the challenges that Institutional Review Board (IRB) members face when reviewing research protocols that involve artificial intelligence (AI), strategies for addressing those challenges, current events and trends that may impact human subjects research involving AI, and additional resources that you can utilize if you are involved in this space.Our guest is Tamiko Eto, MS, CIP who manages research compliance at the Division of Research at Kaiser Permanente. Tamiko also serves on the AI Ethics Advisory Board for Northeastern University's Institute of Experiential AI.Additional Resources:HHS definitions of human subject and research: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102Nils Nilsson definition of AI: https://ai.stanford.edu/~nilsson/QAI/qai.pdfJoanna Bryson and Jeremy Wyatt definition of AI: http://www.cs.bath.ac.uk/~jjb/web/whatisai.htmlOHRP list of ethical codes and research standards: https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.htmlSACHRP considerations for IRB review of research involving AI: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-e-july-25-2022-letter/index.htmlFDA guidance: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samdOSTP blueprint for AI bill of rights: https://www.whitehouse.gov/ostp/ai-bill-of-rights/EU proposed AI Act: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206CITI Program AI content: https://about.citiprogram.org/course/technology-ethics-and-regulations/PRIM&R webinars: https://primr.org/online-learning/webinarsIRB reviewer checklist and decision tree: https://etohconsulting.com/wp-content/uploads/2021/12/ai-hsr-irb-reviewer-checklist-with-decision-tree.pdfWhite paper on IRB review of AI HSR: https://techinhsr.com/2022/08/25/how-to-conduct-an-effective-irb-review-of-artificial-intelligence-human-subjec/

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Medical Device News - December 2022

european european union risk fda guidance developers czech republic eo medical devices importers en txt

Play Episode Listen Later Dec 6, 2022 33:19

HOT TOPICS Europe Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745https://webgate.ec.europa.eu/regdel/#/implementingActs/7377?lang=en https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2346 Reclassification of groups of certain active products without an intended medical purposehttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32022R2347 Updated information pack for candidate EU reference laboratories publishedhttps://health.ec.europa.eu/latest-updates/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en 51th CAMD Meeting Statement (The European Competent Authorities for Medical Devices (CAMD))https://www.camd-europe.eu/other/51th-camd-meeting-statement/ MDCG 2022-16: Guidance on Authorised Representatives Regulationhttps://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf New Notified Body EU MDR: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s (Czech Republic)https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320100&version_no=24 TrainingDecember 12th until December 16th https://school.easymedicaldevice.com/product/gb UK MHRA: Borderline products: how to tell if your product is a medical device: New section added 'Risk classification of medical devices'https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device#risk-classification-of-medical-devices Swissmedic: Plan to accept FDA products in Switzerlandhttps://www.swiss-medtech.ch/en/news/politicians-decide-favour-patient-care https://par-pcache.simplex.tv/subject/?themeColor=AA9E72&subjectID=58905&language=de Finland: Power blackouts do not require special preparedness measures from the users of medicines and medical deviceshttps://www.fimea.fi/web/en/-/power-blackouts-do-not-require-special-preparedness-measures-from-the-users-of-medicines-and-medical-devices Rest of the world United States: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox)https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices#templates United States: MedSun Newsletter - November 2022https://www.fda.gov/media/162771/download Canada: List of recognized standards for medical devices:https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance/list-recognized-standards-medical-devices-guidance.pdf Canada: November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reportinghttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/11-08-changes-reporting-medical-device-shortage.html Barhain: Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registrationhttps://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers and Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124.pdf If you look for an Authorized Representative or Importer in the European area, contact us at EO@easymedicaldevice.com PODCASTS Episode 205: Your Software/IVD clinical report is completely WRONG! https://podcast.easymedicaldevice.com/205/ Episode 206: Regulatory Pathway: How to reach the US market? [510k exempt] https://podcast.easymedicaldevice.com/206-2/ Episode 207: Why Risk Management is important to Medical Device development? https://podcast.easymedicaldevice.com/207-2/ Episode 208: How to choose the best Sterilization Method for Medical Devices? https://podcast.easymedicaldevice.com/208-2/

Why Risk Management is important to Medical Device development?

Effekten: digitalisering - kunskap

Play Episode Listen Later Nov 22, 2022 20:51

Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a NASA Ambassador. He will share with us his experience. PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don't hesitate to contact Easy Medical Device. See the link below. Who is Kailash Kalidoss? The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I'm also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California. Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition. SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links Kailash Kalidoss LinkedIn: https://www.linkedin.com/in/kailashkalidoss iso 14971:2019. https://www.iso.org/standard/72704.html EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424 Authorized Representative and Importer for EU, UK, and Switzerland: https://easymedicaldevice.com/authorised-representative-and-importer/ eQMS SmartEye: https://scube-technologies.com/why-s-cube/

AI – hot och möjligheter. Magnus Carling (# 188)

Play Episode Listen Later Sep 28, 2022 24:59

"Det är en helt flock av vargar som kommer emot oss". Den liknelsen gör Magnus Carling i detta avsnitt som handlar om artificiell intelligens och vår framtid tillsammans med den. Magnus jobbar som CISO på Stena AB. Allt handlar om säkerhet och vara med på att kontrollera nästa steg. Om avsnittet: Målgrupp: allmänhet, ledning, it-folk, företag, ledare, projektledare, management Lär dig: AI, digitalisering, cybersäkerhet, verksamhetsutveckling, machine learning Vi gasar på i digitaliseringen och vi har inte reflekterat på att kanske måste bromsa. När vi exponeras av chatbotar som blir rasister och deep fake som används i propaganda så är detta bara början. Många vet inte hur detta kommer att påverka det vi gör dagligen. Cybersäkerhet 1-1 bör kanske införas i skolan och vi behöver snart en "god AI" för att rädda oss från en "ond AI". Vi har idag robotar som forskar på att utrota covid. Kommer denna forskning att slå fel och forska fram ett nytt virus som är värre? Offensiva cyberkrigare finns redan och autonoma vapen finns. Hur reglerar vi etik och kanske vi behöver bromsa utveckling. Magnus ställer sig frågan om vi ska ha en AI som kan bestämma vem som ska anställas och avskedas. Vi bör skapa en medvetenhet och prata om dessa hot och möjligheter. Säkerhet bör komma högre upp på alla verksamheters agenda. Organisationer ska börja dela kunskap och information mellan varandra. EU AI Act är ett av de första förordningarna som kan reglera AI. Lär dig att kontrollera risken och skena inte iväg för snabbt med AI tillämpningar. Detta är en styrelsefråga inom våra organisationer, det kräver utbildning och det är en kultur som vi måste skapa för att kontrollera framtiden. Magnus Carling, Jonas Jaani (24:58) Länkar / mer information: AI Act - https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0206 Magnus böcker. Bland annat nya boken "Svart Storm" - https://www.magnuscarling.com/bocker/ Sahlgrenskas AI-arbete - https://www.sahlgrenska.se/forskning-utbildning-innovation/innovation/kompetenscentrum-ai/ Chattroboten Tay blev rasist - https://www.theguardian.com/technology/2016/mar/24/tay-microsofts-ai-chatbot-gets-a-crash-course-in-racism-from-twitter Kurzweil om singulariteten - https://futurism.com/kurzweil-claims-that-the-singularity-will-happen-by-2045 (Kurzweil är erkänd forskare och futurist som ägnat mycket forskning åt AI) Stephen Hawking och fyra andra om riskerna med AI - https://time.com/3614349/artificial-intelligence-singularity-stephen-hawking-elon-musk/ Alla avsnitt av digitaliseringens podcast Effekten: https://www.effekten.se/avsnitt Vi finns där du hittar dina övriga poddar: https://www.effekten.se/prenumerera/ Apple Podcasts: https://itunes.apple.com/se/podcast/effekten-digitalisering-kunskap/id1171229363 Google Podcasts: https://www.google.com/podcasts?feed=aHR0cHM6Ly93d3cuZWZmZWt0ZW4uc2UvZmVlZC9wb2RjYXN0Lw== Acast: https://www.acast.com/effekten Spotify: https://open.spotify.com/show/5Z49zvPOisoSwhwojtUoCm https://open.spotify.com/show/5Z49zvPOisoSwhwojtUoCm

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How to select your Notified Body and understand the full process?

europe uk body european union healthcare switzerland select ec regulatory affairs notified t v s d en txt eu mdr

Play Episode Listen Later Sep 27, 2022 33:12

The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects. There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under EU MDD 93/42/EC so this means that there will be a big bottleneck. So let us help you go over it and really make the right decisions. To get all the information about this process with Notified Bodies, go to the Annex VII of the EU MDR and IVDR Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 First audits conclusion episode with Martin Witte: https://podcast.easymedicaldevice.com/140/ Qualitiso Notified Body price: https://www.qualitiso.com/en/comparison-of-notified-body-fees/ EU MDR link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128#tocId166 Technical File Episode: https://podcast.easymedicaldevice.com/191/ Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/102/ First results of Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/136/ TÜV SÜD pre-application form: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration

TIFLIL - Is-Sistema Elettorali #2 - David Grech

Jon Mallia Podcast

Play Episode Listen Later Aug 31, 2022 15:21

Ghat-TIENI episodju ta' TIFLIL dwar IS-SISTEMA ELETTORALI jien u David qaxxarna l-basla tas-SINGLE TRANSFERABLE VOTE, coè s-sistema ta' votazzjoni li nhaddmu f'dan il-pajjiz. Ghalija dan l-episodju huwa aktar importanti mill-ewwel wiehed ghax ghandu element preskrittiv li jista' jibda jippuntana lejn xi soluzzjonijiet. F'din id-diskursata jien u David flejna diversi sistemi li wiehed isib madwar id-dinja, u x'inhuma l-vantaggi u l-izvantaggi ta dawn is-sistemi. Naqra ta' contrast and compare. Il-qofol tad-diskursata twassalna biex insibu xi risposti ghall-mistoqsija "Kieku int xi tbiddel?". David qasam mieghi HAMES PUNTI fejn is-sistema taghna tista' tinbidel ghall-ahjar. Hames punti li nemmen li kull min irid jara Malta iktar demokratika ghandu jomghodhom ftit. Infakkar li din is-serje TIFLIL tixxandar esklussivament fuq Patreon.com/jonmallia U li dawn id-diskursati ma' David bdew ghaliex David huwa Patrun, u f'diversi mill-attivitajiet li naghmlu ghall-Patruni taghna, kellna c-cans niddiskutu certi hwejjeg b'mod hieles. Jekk ghadek ma ssehibtx maghna, inheggek tidhol f'din il-komunità biex int ukoll tkun parti mid-diskussjoni. Biex torjenta ruhek ahjar fil-konverzazzjoni; Spjegazzjoni tas-SINGLE TRANFERABLE VOTE: https://www.youtube.com/watch?v=iKKC8dhwPak Treaty on the Functioning of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12016E/TXT

european union sistema malta functioning hames grech en txt jekk

The New Blue Guide - What is the impact to the Medical Device Industry?

Play Episode Listen Later Aug 23, 2022 37:31

The new Blue Guide is out. So what are the changes for Medical Device Manufacturers? Erik Vollebregt will give us his analysis and also some revelation on the Swiss MRA process if you are still in need of the situation in Switzerland. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and personal data protection. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company is also acting as Authorized Representative for the EU, UK, and Switzerland? Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt Axon Lawyers: https://www.axonlawyers.com/ Blue Guide link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC Blog Blue Guide: 2022 Update: https://medicaldeviceslegal.com/2022/08/07/the-blue-guide-2022-update-new-elements-regarding-applicability-of-eu-law-on-products/

How to create a Technical Documentation? [EU MDR and IVDR]

social media european union healthcare videos technical documentation regulatory affairs gspr en txt ivdr eu mdr

Play Episode Listen Later Aug 2, 2022 31:04

The creation of a Technical File or Technical Documentation for CE marking is really a challenge sometimes. After successfully passing audits with my customers, I want to share with you some best practices to create your Technical Documentation. I will even explain to you how to reference your annexes or what to do with the GSPR. So don't miss it. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424 EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128#tocId129 How to comply with GSPR: https://easymedicaldevice.com/gspr/ Technical Documentation blog post: https://easymedicaldevice.com/technical-documentation/ How to write your declaration of conformity: https://easymedicaldevice.com/declaration-of-conformity/ eQMS Scube SmartEye: https://scube-technologies.com/ Easy Medical Device Shop: https://school.easymedicaldevice.com/shop/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Regulating AI with Dr. Rowena Rodrigues

Your AI Injection

Play Episode Play 30 sec Highlight Listen Later Jul 18, 2022 46:54 Transcription Available

As AI becomes increasingly powerful, concerns about abuses grow. Consideration of the potential of future AI innovations leaves us with a burning question: does AI require regulation, and if so, how should AI be regulated and who should make those decisions? In this episode, we speak with Dr. Rowena Rodrigues, Head of Innovation and Research at Trilateral Research, a UK based organization that provides ethical AI software solutions. Deep and Dr. Rodrigues discuss the importance of data transparency and how to balance innovation and regulation. They also speculate about what it might take for stricter regulatory legislation in AI to be enforced and how these regulations might evolve over the next decade.Want to dive deeper? Explore some of the topics introduced by Dr. Rodrigues below:EU AI Act proposal: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206SIENNA project: https://www.sienna-project.eu SHERPA project: https://www.project-sherpa.eu

head ai uk research innovation explore considerations rodrigues regulating eu ai act en txt

L'intelligence artificielle dans les DM - Partie 3

Deux mots sur les dispositifs mÃ©dicaux

Play Episode Listen Later Jun 18, 2022 8:02

Dans ce 21ème et dernier épisode de la Saison 2, je vous propose une troisième partie à notre mini-série sur l'intelligence artificielle (IA) dans les DM. Comment mettre un DM contenant de l'IA sur le marché ? Quelles réglementations ? Comment gérer le problème du manque de données ? Un grand merci pour votre fidélité au cours de cette deuxième saison ! J'espère pouvoir vous retrouver dans une troisième à la rentrée. Très bel été à tout le monde ! Pour creuser le sujet : Règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux, modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009 et abrogeant les directives du Conseil 90/385/CEE et 93/42/CEE Règlement (UE) 2016/679 du Parlement européen et du Conseil du 27 avril 2016, relatif à la protection des personnes physiques à l'égard du traitement des données à caractère personnel et à la libre circulation de ces données, et abrogeant la directive 95/46/CE (règlement général sur la protection des données). Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (artificial intelligence act) and amending certain union legislative acts : https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1623335154975&uri=CELEX%3A52021PC0206 Dario Martinez - Is Transfer Learning the final step for enabling AI in Aviation? https://datascience.aero/transfer-learning-aviation/ Pour en savoir un peu plus sur l'auteur : https://fr.linkedin.com/in/nicolas-martelli-a0b4495 Générique : Days Past - In Closing - Licence: https://creativecommons.org/licences/by/3.0/deed.fr - outro: Zoltan Precsenyi

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Medical Device News - June 2022 Regulatory Update

Play Episode Listen Later Jun 7, 2022

Here is your Medical Device Regulatory update. This will be focused on the IVDR 2017/746 that went live. So let's update you on some key changes. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses... Links NEWS - Swiss: MRA situation for IVDR; https://ec.europa.eu/health/document/download/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf - Swiss: new IvDV (Ordinance on in-vitro diagnostics): https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html ○ Swiss Odiv: https://www.fedlex.admin.ch/eli/cc/2022/291/fr - Swiss: Performance studies of IVD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/leistungsstudien.html ○https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf - EU: Team NB Survey: https://www.team-nb.org/wp-content/uploads/2022/05/Survey-2021-20220516.pdf - EU: Harmonized standard for IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729 - EU: Harmonized standard for MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0757 - Italy: Establishment of the National Surveillance Network: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5894 - Preparing for UKCA marking of Medical Device with Ronald Boumans: https://boumansconsulting.com/expert-center/tip-of-the-week/preparing-for-ukca-marking-of-medical-devices/ - Green Belt Certification June 2022: https://school.easymedicaldevice.com/course/gb19/ NOTIFIED BODY - 3EC International - IVDR 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3 - TÜV Nord - EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317538&version_no=8 - Berlin Cert - EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43955 - Overview NB each stage: https://ec.europa.eu/health/system/files/2022-05/notifiedbodies_overview_en.pdf GUIDANCE - MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf - MDCG 2022-7 Q&A UDI System: https://ec.europa.eu/health/document/download/b5429d14-25a9-4cfc-b059-355388f03e05_en?filename=mdcg_2022-7_en.pdf - MDCG 2022-8 IVD Legacy devices: https://ec.europa.eu/health/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf - MDCG 2022-9 Summary of safety and performance template: https://ec.europa.eu/health/document/download/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf - MDCG 2022-10 Q&A interface 536/2014 on clinical trials for medicinal products for human use and IVDR: https://ec.europa.eu/health/document/download/59abcc81-fd32-4546-a340-24c8fad4e2ac_en?filename=mdcg_2022-10_en.pdf PODCAST - Episode 179 - How to certify your Software as a Medical Device? With Vivek Thakkar: https://podcast.easymedicaldevice.com/179/ - Episode 180 - What happens after the IVDR Date of Application with Colm O'Rourke: https://podcast.easymedicaldevice.com/180/ - Episode 181 - What to learn about the EU Medical Device Situation? https://podcast.easymedicaldevice.com/181/ -Episode 182- Let's introduce our eQMS Smarteye with Anindya Mookerjea: https://podcast.easymedicaldevice.com/182/

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Medical Device News - May 2022 Regulatory Update

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Play Episode Listen Later May 3, 2022

In this episode, I will update you regarding all the changes in the Medical Device Quality and Regulatory Field. Below are all the topics we will discuss during this episode. Don't miss the latest updates. EU EUDAMED & Certificate: https://ec.europa.eu/health/medical-devices-eudamed/notified-bodies-and-certificates-module_en EUDAMED Notified Body User guide: https://ec.europa.eu/health/document/download/8b6132fd-75ed-4e8b-8be5-920725037221_en?filename=md_eudamed-nb-user-guide_en_0.pdf EUDAMED Economic Operator User Guide: https://webgate.ec.europa.eu/eudamed-static/documents/assets/guides/user_guide_eo_en.pdf Delegated acts: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2022:182:FIN TURKEY: Reminder custom agreement: https://ec.europa.eu/health/latest-updates/notice-stakeholders-eu-turkey-customs-union-agreement-field-medical-devices-2022-04-13_en Spain: CCPS registration of IVD until EUDAMED is fully available: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/informacion-sobre-la-comunicacion-de-productos-sanitarios-de-diagnostico-in-vitro-en-ccps/ USA MDSAP Audit Approach: https://www.fda.gov/media/157861/download FDA: Refuse to accept Policy for 510k: https://www.fda.gov/media/83888/download FDA Medsun Newsletter: https://www.fda.gov/media/157448/download MEA Ethiopia: Labelling requirements: http://www.fmhaca.gov.et/wp-content/uploads/2022/04/Guidelines-for-Medical-device-Labeling.pdf ASIA Malaysia: Labelling requirements: https://www.mda.gov.my/documents/draft-guidance-documents/1969-attachment-1-public-comment-mda-gd0026-requirement-on-labelling-of-md/file.html EVENT Medtech Forum: https://www.themedtechforum.eu/ SFDA: Webinar Clinical Evaluation and PMCF: https://www.sfda.gov.sa/en/workshop/86686 GUIDANCES MDCG Subgroup development and deliverables – https://ec.europa.eu/health/system/files/2022-04/mdcg_ongoing_guidancedocs_en.pdf MDCG 2022-5 Borderline: https://ec.europa.eu/health/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en_0.pdf WHO Guidance: PMS for MD and IVD. https://www.who.int/publications/i/item/9789240015319 NOTIFIED BODIES: IVDR: 3EC international. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3 Easy Medical Device Nostalgia: Episode 175: How to prepare an audit with Front Room Back Room: https://podcast.easymedicaldevice.com/175/ Episode 176: How your PMCF is evaluated by a Notified Body with Matthias Fink from TÜV SÜD: https://podcast.easymedicaldevice.com/176/ Episode 177: Training process with Rod Beuzeval and Katie Cooney from Trinzo and Meddev Solutions: https://podcast.easymedicaldevice.com/177/

#351: Machine Learning Ethics and Laws Panel

Talk Python To Me - Python conversations for passionate developers

Play Episode Listen Later Feb 3, 2022 70:28

The world of AI is changing fast. And the AI / ML space is a bit out of the ordinary for software developers. Typically in software, we can prove that given a certain situations, the code will always behave the same. We can point to where and why a decision is made. ML isn't like that. We set it up and then it takes on a life of its own. Regulators and governments are starting to step in and make rules over AI. The EU is one of the first to do so. That's why it's great to have Ines Montani and Katharine Jarmul, both awesome data scientists and EU residents, here to give us an overview of the coming regulations and other benefits and pitfalls of the AI / ML space. Links from the show Katharine Jarmul on Twitter: @kjam Katharine's site: kjamistan.com Ines Montani on Twitter: @_inesmontani Explosion AI: explosion.ai EU proposes new Artificial Intelligence Regulation: nortonrosefulbright.com The EU's leaked AI regulation is ambitious but disappointingly vague: techmonitor.ai EU ARTIFICIAL INTELLIGENCE ACT: eur-lex.europa.eu/legal-content Facial Recognition Technology Ban Passed by King County Council: kingcounty.gov On the Opportunities and Risks of Foundation Models paper: arxiv.org thoughtworks: thoughtworks.com I don't care about cookies extension: chrome.google.com Everybody hates “FLoC,” Google's tracking plan: arstechnica.com Watch this episode on YouTube: youtube.com Episode transcripts: talkpython.fm --- Stay in touch with us --- Subscribe on YouTube: youtube.com Follow Talk Python on Twitter: @talkpython Follow Michael on Twitter: @mkennedy Sponsors Sentry Error Monitoring, Code TALKPYTHON SignalWire Talk Python Training

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Episodi 81 - Sicherheitskreise

Turvakäräjät

Play Episode Listen Later Jan 24, 2022 75:48

Juhon pieni argentiilainen startup https://www.accenture.com/fi-en/services/security/cyber-defenseHackerOne brandilähettilääthttps://www.hackerone.com/ethical-hacker/announcing-hackerone-brand-ambassadorsThe Spice Must Flow… on the blockchain!https://dune.foundation/Spice DAO osti Dune-kirjan kolmella miljoonallahttps://hypebeast.com/2022/1/spice-dao-nft-3-million-usd-christies-auction-frank-herbert-alejandro-jodorowsky-dune-book-purchaseJodorowskin Dune-kirja poltetaan ja muutetaan NFTiksi? Poistettu, mutta internet ei unohda.https://web.archive.org/web/20220117145921/https://forum.spicedao.xyz/t/nft-of-the-book-w-proof-of-jpeg-proof-of-burn/48Pitko dippaahttps://www.coindesk.com/markets/2022/01/21/bitcoin-dips-below-40000-during-broader-asia-market-sell-off/Kiina vakoilee UEFI-maltsullahttps://securelist.com/moonbounce-the-dark-side-of-uefi-firmware/105468/https://arstechnica.com/information-technology/2018/10/first-uefi-malware-discovered-in-wild-is-laptop-security-software-hijacked-by-russians/Europolin datakasan regulaattorin hampaissahttps://amp-theguardian-com.cdn.ampproject.org/c/s/amp.theguardian.com/world/2022/jan/10/a-data-black-hole-europol-ordered-to-delete-vast-store-of-personal-datahttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020PC0796EncroChat ei kelpaa todisteeksi Berliinissähttps://www.computerweekly.com/news/252503524/Berlin-court-finds-EncroChat-intercept-evidence-cannot-be-used-in-criminal-trials

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TietosuojaPod #31: Uusi vuosi, vanhat kujeet

TietosuojaPod

Play Episode Listen Later Jan 11, 2022 54:45

Erinomaista uutta vuotta 2022 kaikille podin kuuntelijoille! Palaamme TietosuojaPodin pariin tuttuun tapaan setillä tuoreita uutisia tietosuojan maailmasta. Vastaamoa koskien saatiin viimein edellisen vuoden lopussa tietosuojavaltuutetun toimiston päätös. Onko annettu sakko oikeasuhtainen, vai kannattaako kaikkien yritysten nyt ajaa itsensä konkurssiin tietosuojavelvoitteiden noudattamisen sijasta? Muissa uutisissa puhuttaa mm. CNIL:n jättimäiset evästesakot Googlelle ja Facebookille sekä Hollannin lapsilisäskandaali. Vastaamolle 608 000 euron sakko https://finlex.fi/fi/viranomaiset/tsv/2021/20211183 https://yle.fi/uutiset/3-12134525 TSV:n maksuhäiriötietojen käsittelyä koskeva päätös https://tietosuoja.fi/-/luottotietorekisteriin-luovutettu-ja-merkitty-virheellisesti-maksuhairiotietoja Ranskassa evästesakot Googlelle ja Facebookille https://www.cnil.fr/en/cookies-facebook-ireland-limited-fined-60-million-euros https://www.cnil.fr/en/cookies-google-fined-150-million-euros Hollannin valtiolle GDPR-sakko https://netzpolitik.org/2022/childcare-benefits-scandal-dutch-government-to-pay-million-euro-fine-over-racist-data-discrimination/ Whatsapp vs. EDPB https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62021TN0709 Voit seurata TietosuojaPodia Twitterissä täältä: https://twitter.com/PodPrivacy Voit lähettää meille palautetta Twitterin yksityisviestinä, hashtagilla #tietosuojapod tai sähköpostilla tietosuojapod@protonmail.com Seuraa meitä myös Instagramissa ja LinkedInissä nimellä privacypod!

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Medical Device News: December 2021 Regulatory Update

Play Episode Listen Later Dec 7, 2021

EUDAMEDCommission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_enEUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdfInfographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdfCategorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdfRegistration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdfIVDR expert panelView in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdfFollowing MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdfEU Reference laboratories (EURL)Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EURL-fees_enGermany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devices/Contact-persons/_artikel.html?nn=968830Ireland – HPRA: In-house Manufacturing of in vitro diagnostic medical devices – SurveyDue December 17th, 2021 http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/in-house-manufacturing-of-in-vitro-diagnostic-medical-devices-stakeholder-survey&id=07891026-9782-6eee-9b55-ff00008c97d0Ireland – HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/applying-for-a-certificate-of-free-sale-updated-information&id=d4731026-9782-6eee-9b55-ff00008c97d0Annex XVI products – Finland – FIMEAhttps://www.fimea.fi/web/en/-/supervision-of-devices-referred-to-in-annex-xvi-of-the-medical-device-regulation-to-begin-in-autumn-2022CHRISTMAS BREAKMHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-deviceBelgium – FAMHP – Christmas period https://www.famhp.be/en/news/deadlines_for_the_submission_of_dossiers_during_end_of_year_periodSwitzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.htmlCH-RN Database: https://opendata.swiss/en/dataset/mep401-chnr-actorsHow to obtain the CHRN: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_11_001defi_fo-registrierungsantrag-einmalige-idnr-art55-mepv.pdf.download.pdf/BW630_11_001defi_FO_Antrag_Registrierung_CHRN.pdfSwitzerland – Procurement: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/beschaffung.htmlUK MHRA: Review launched into the health impact of potential bias in medical devices : https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devicesWORLDUSA: Final rule for Medical Device De Novo Classification Processhttps://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-rule-medical-device-de-novo-classification-processPodcast episode 43 – How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo…)USA: Draft Guidance 510K Device Software function SaMDWebinar Dec 16th, 2021 – Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-draft-guidance-content-premarket-submissions-device-software-functions-12162021-12162021Draft guidance: https://www.fda.gov/media/153781/downloadUSA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-programNon-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/downloadIn Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/downloadSaudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default/files/2021-11/GuidanceBorderlineProductsClassificationE.pdfNotified BodySGS Belgium: https://www.sgs.com/en/news/2021/11/sgs-belgium-nv-confirmed-as-a-notified-body-for-the-new-eu-medical-device-regulation-mdrMDR 25: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34IVDR 2017/746 6: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35EMDPodcastEpisode 153 – How to improve your QA RA Communication with Lesley Worthington: https://podcast.easymedicaldevice.com/153/Episode 154 – Is it possible to Private Label a Medical Device under MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/154/Episode 155 – How to approach your Notified Bodies? With Dr Royth von Hahn https://podcast.easymedicaldevice.com/155/Episode 156 – Unleashing “MDR Classification surprises with Franck Matzek https://podcast.easymedicaldevice.com/156/LinkedIn LiveTalk Cybersecurity during MDR audit with Stefan Bolleininger: https://www.youtube.com/watch?v=IK0DiXnISKE&t=4sIVDR 2017/746 – in-house devices: https://www.youtube.com/watch?v=AbwaA7DpbYI The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

S8E6: Mirabelle: Plums, Spirit, and ... Poodles?

Play Episode Listen Later Nov 26, 2021 12:25

Mirbelle eau-de-vie is a specialty from the Lorraine region of France. We discuss Mirabelle plums, the spirit by the same name, production regulations, a cocktail recipe, and … what do poodles have to do with any of it? Resources from this episode: Websites & Documents: Bubbly Professor: Lorraine: Quiche, Plums, and a Bit of Wine, Nickles, J. (9 September 2016) https://bubblyprofessor.com/2016/09/09/lorraine-quiche-plums-and-a-bit-of-wine/ Cahier des Charges de L'Appellation d'Origine Controlee, Mirabelle de Lorraine (29 January 2015) https://info.agriculture.gouv.fr/gedei/site/bo-agri/document_administratif-d0be9622-e29c-4dfa-bbbb-2fafaebf8acd/telechargement EUR-Lex (Access to European Union Law): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0110 Liquor.com: Everything You Need to Know About Eau-de-Vie, Nusog, T. https://www.liquor.com/articles/eau-de-vie/ Lorraine Magazine: La Mirabelle - la reine en sa région, #32 (27 August - 9 September 2014) https://www.lorrainemag.com/a-la-une/la-mirabelle-la-reine-en-sa-region/ New York Times: Eau de Vie: Fruit's Essence Captured in a Bottle, Apple, R.W. Jr.(1 April 1998) https://www.nytimes.com/1998/04/01/dining/eau-de-vie-fruit-s-essence-captured-in-a-bottle.html Podcasts: Glass in Session® Winecast: S2E3: Apple Brandy - Domestic Happiness https://glassinsession.libsyn.com/s2e3-apple-brandy-domestic-happiness Glass in Session® Winecast: S5E5: Grape Brandy Escape https://glassinsession.libsyn.com/s5e5-grape-brandy-escape Glass in Session® Winecast: S6E2: A Pisco Party! https://glassinsession.libsyn.com/s6e2-a-pisco-party Glass in Session® Winecast: Bonus Episode: Online Wine Learning and Admiral Nelson-ing Your Liquor Shelf - Interview with Jane Nickles, CWE, CSE https://glassinsession.libsyn.com/online-wine-learning-and-admiral-nelson-ing-your-liquor-shelf YouTube Channels: B-52s: Quiche Lorraine (3 December 2014) https://www.youtube.com/watch?v=HJxz3owrJ80 Glass in Session® is a registered trademark of Vino With Val, LLC. Music: “Write Your Story” by Joystock (Jamendo.com cc_Standard License, Jamendo S.A.)

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eBay for Business - Ep 138 - Coded Coupons; Preparing for the Summer Retail Moments

Selling on eBay

Play Episode Listen Later Apr 27, 2021 41:12

Give us a call - 888-723-4630 Send us an email - podcast@ebay.com visit us at ebay.com/podcast Welcome to eBay for Business! This week, eBay Product Manager Bérengère Chaintreau Fuchs gives us a deep dive into the new Coded Coupon feature; Kirsty Dunn brings us the best submissions of tips from sellers from our recent Sweepstakes; Griff unearths an interview from the eBay Open 2019 archives about one of his favorite topics; and Rebecca joins this week to help answer three eBay seller questions about parcel sizes, feedback and retrieving old eBay data. To have your questions answered on our eBay for Business podcast, call us at 888 723-4630 or email us at podcast@ebay.com. To give us feedback, please take our podcast listener survey at (https://connect.ebay.com/srv/survey/a/sellerops.podcast) 00:01 - Intro 04:35 - Latest Sweepstake Tips with Kirsty Dunn 13:46 - Coded Coupons with Bérengère Chaintreau Fuchs 23:!6 - Thermal Printers at eBay Open 2019 with Daniel Gallahger 29:15 - Q&A and Outro New Links for Ep 138: eBay Help Page on the EU Rules Regarding Products Marked with CE - https://www.ebay.com/help/selling/selling/CE-mark-EU?id=5225 REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32019R1020 Guidelines for economic operators and market surveillance authorities on the practical implementation of Article 4 of Regulation (EU) 2019/1020 on market surveillance and compliance of products. - https://ec.europa.eu/docsroom/documents/44908 Recent eBay Sweepstakes Post on the eBay For Business Facebook page - https://www.facebook.com/eBayForBusiness/photos/a.514051868672414/3901716083239292/ Promotions Manager (Coded Coupons) - https://pages.ebay.com/seller-center/listing-and-marketing/promotions-manager.html#promotions-options Daniel Gallhager’s eBay Store Refurb-World-LLC - https://www.ebay.com/str/refurbworldllc Recurring Links / Phone Numbers / Hashtags Mentioned: 888-723-4630 - Call in Line eBay Seller News Announcements - ebay.com/announcements eBay Community - ebay.com/community eBay Weekly Community Chat - ebay.com/communitychat eBay Help - ebay.com/help/home eBay Meetups - ebay.com/meetups Managed Payments on eBay - ebay.com/payments eBay for Business Podcast - ebay.com/podcast eBay Seller Center - ebay.com/sellercenter eBay Seller Hub - ebay.com/sh eBay System Status - ebay.com/sts explore.ebay.com facebook.com/eBayForBusiness eBay for Business Podcast Listener Survey - https://connect.ebay.com/srv/survey/a/sellerops.podcast #ebaypodcast

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S6E2: A Pisco Party!

PayTechTalk - the Podcast of PAYMENT.TECHNOLOGY.LAW. | PayTechLaw

Play Episode Listen Later Jan 25, 2021 19:06

No, not a "disco" party, thank you very much, autocorrect. A Pisco Party! We're talking about distilled spirits from Peru and Chile: what they are, how they are made, and the many differences between them. They are unique and distinct beverages from their respective countries of origin, and the differences between the two make the two Piscos fascinating spirits to explore, from history to grape to their role in their national cocktails. Resources from this episode: Books: Certified Specialist of Spirits Study Guide (Society of Wine Educators), Nickles, J., (2020) Websites: Comisión Nacional del Pisco - Peru (CONAPISCO) https://conapisco.org.pe/ Cornell Law School: Electronic Code of Federal Regulations (eCFR), Title 27 Section 5.22 - The Standards of Identity (d) Class 4; brandy, (9) Pisco. https://www.law.cornell.edu/cfr/text/27/5.22 EUR-Lex (Access to European Union Law): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0110 Peru: Spirit of Peru https://peru.info/en-us/piscospiritofperu#production Peru Travel Info (maps) http://peru-travel-info.com/peru-maps.html Pisco Chile: https://piscochile.com/en/home/ Pisco World (Perú): http://www.piscoworld.com/ Podcasts: Glass in Session®: Grape Brandy Escape https://glassinsession.libsyn.com/s5e5-grape-brandy-escape Wine Two Five: Pisco Unpacked https://podcasts.apple.com/us/podcast/pisco-unpacked/id986650051?i=1000397336490 Glass in Session® is a registered trademark of Vino With Val, LLC. Music: Addict Sound (Jamendo.com cc_Standard License, Jamendo S.A.)

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PayTechTalk 59 - Blockchain- and Crypto-Regulation from an international perspective

Play Episode Listen Later Dec 21, 2020 55:37

In this episode of PayTechTalk I am talking to Blockchain and DLT-expert Nathan Catania (XReg Consulting) on Blockchain- and Crypto-Regulation from an international perspective. The AML Environment of Crypto and Blockchain Since 2014, the Financial Action Task Force (FATF) has been warning about the risks of virtual currencies (Bitcoin) in connection with money laundering (ML) and terrorist financing (TF). Since then, the FATF has adapted its recommendations several times and published a large number of publications on virtual assets. The EU has implemented the FATF recommendations with the 5th Anti Money Laundering Directive and regulates virtual currencies and their service providers (VASP). Virtual Currencies vs. Virtual Assets The FATF and the international community originally only had Bitcoin and thus virtual currencies on their radar. However, this has now changed. The crypto market has evolved and now virtual assets (crypto assets) and crypto asset service providers are to be regulated. The Future Regulation of Virtual Assets (Crypto Assets) The FATF continues to make recommendations on virtual assets. The aim is to examine annually what the international community can improve in order to better manage the ML and TF risks of virtual assets and VASPs. In particular, the focus is on the so-called Travel Rule. At the European level, the European Commission is endeavouring to create a uniform EU regulatory framework with the Markets in Crypto Assets Regulation (MiCAR). In the future, this should directly regulate the issuance and distribution of all crypto assets for all EU member states. An exciting topic, it’s worth listening in! Enjoy PayTechTalk 59! This Podcast is in English. Further information and links: https://www.fca.org.uk/firms/financial-crime/cryptoassets-aml-ctf-regime https://www.fatf-gafi.org/publications/fatfrecommendations/documents/guidance-rba-virtual-assets.html http://www.fatf-gafi.org/publications/methodsandtrends/documents/virtual-assets-red-flag-indicators.html http://www.fatf-gafi.org/media/fatf/documents/bulletin/fatf-booklet_va.pdf https://www.fatf-gafi.org/publications/fatfrecommendations/documents/12-month-review-virtual-assets-vasps.html https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020PC0593 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12089-Financial-services-EU-regulatory-framework-for-crypto-assets https://inatba.org/mica-task-force/ More on Nathan Catania and XReg Consulting Nathan is a Partner at XReg Consulting He has hands-on experience in public policy formulation and regulatory proposal development for blockchain, distributed ledger technology (DLT), and crypto assets. Nathan was with the DLT team at the Gibraltar Financial Services Commission (GFSC), where he was primarily responsible for reviewing regulated firms’ compliance with financial resource requirements and safeguarding client assets. Nathan was active in developing internal regulatory policies and procedures that addressed technical and emerging aspects of the DLT industry. During his time at GFSC, Nathan built his technical knowledge in DLT and earned a Blockchain Expert Certification from the Frankfurt School of Finance & Management. XReg Consulting is a consulting firm specializing in crypto assets regulatory consulting. XReg’s founding partners are all former regulators with years of practical experience in strategy and policy development in the financial services and crypto assets environment.

Ep21: Claude Turmes ‘Clean Energy Coalition-builder'

Cleaning Up. Leadership in an age of climate change.

Play Episode Listen Later Dec 2, 2020 56:50

What happens behind the scenes of the EU Parliament? One of the leading figures in European politics, Claude Turmes, the Minister for Energy and Minister for Spatial Planning in Luxembourg, joins Michael Liebreich for episode 21. As a member of the European Green Party and a former Member of the European Parliament for 19 years, Claude has extensive experience representing the parliament in international climate change conferences. Bio/Introduction Claude Turmes has been the rapporteur of a large number of European directives, in particular on renewable energies, energy efficiency, the electricity market and climate plans, as well as on the European lobby register. He was the rapporteur on the EU Renewable Energy Directive 2009/28. From 2004 to 2018, he was the chairman of EUFORES (European Forum for Renewable Energy Sources), the Interparliamentary association for the promotion of renewable energies in Europe. Moreover, He represented the Parliament at the 2008 United Nations Climate Change Conference in Poznań and the 2016 United Nations Climate Change Conference in Marrakech. Prior to his election to the European Parliament, Claude Turmes was an activist and, later, he volunteered to lead various environmental associations. He has been active at both the European (Friends of the Earth Europe, the European Environmental Bureau) and national level. He was a member of the Committee and Vice-President in charge of energy/climate and European affairs and Europe of the Mouvement Écologique Luxembourg from the late 1980’s to 1999. Claude Turmes was also a teacher from 1983 to 1999 in various secondary schools in Luxembourg. Claude Turmes, after completing his secondary education, he graduated in physical and sport education from the University of Louvain-la-Neuve in 1983. Parallelly to his job, Claude Turmes studied environmental technologies at the Luxembourgish University Foundation in Arlon and finished his studies without the final thesis. Claude Turmes also attended numerous continuing education training in yoga. Key links Official Bio: https://gouvernement.lu/dam-assets/documents/ministres/cv/2019/en/Turmes-EN-Oct2019.pdf Energy Transformation - An Opportunity for Europe (Claude Turme’s book) https://www.libeurop.eu/shop/product/9781785902574-energy-transformation-an-opportunity-for-europe-636012 European Forum for Renewable Energy Sources http://www.eufores.org/ The EU’s state aid regime is upside down (May 2020) https://www.euractiv.com/section/energy-environment/opinion/the-eus-state-aid-regime-is-upside-down/?fbclid=IwAR1l8DFGKKpwOkBzgo_XuQCbQLaNm8vP5ADtQVvNN9udC6kqLzq_ZX9quyc Directive 2012/27/EU of the European Parliament and of the Council (25 October 2012) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32012L0027 Directive 2009/28/EC of the European Parliament and of the Council (23 April 2009) https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009L0028 "LUXEMBOURG IN TRANSITION": TOWARDS ZERO CARBON BY 2050? https://delano.lu/d/detail/news/luxembourg-transition-towards-zero-carbon-2050/212145 About Cleaning Up Once a week Michael Liebreich has a conversation (and a drink) with a leader in clean energy, mobility, climate finance or sustainable development. Each episode covers the technical ground on some aspect of the low-carbon transition – but it also delves into the nature of leadership in the climate transition: whether to be optimistic or pessimistic; how to communicate in order to inspire change; personal credos; and so on. And it should be fun – most of the guests are Michael’s friends. Follow Cleaning Up on Twitter: [https://twitter.com/MLCleaningUp](https://twitter.com/MLCleaningUp) Follow Cleaning Up on Linkedin: [https://www.linkedin.com/company/cleaning-up-with-michael-liebreich](https://www.linkedin.com/company/cleaning-up-with-michael-liebreich) Follow Cleaning Up on Facebook: [https://www.facebook.com/MLCleaningUp](https://www.facebook.com/MLCleaningUp) Links to other Podcast Platforms: [https://www.cleaningup.live/](https://www.cleaningup.live/)

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Episode 67: Access For All: Plain Language

DGT Academy - Radio Ekonomika

Play Episode Listen Later Nov 24, 2020 35:47

James Archibald(McGill University) discusses the key findings of a conference held mid October. Is language a condition to enjoy one’s rights effectively? What if we were all concerned? More about the project to have a language-neutral plain language standard recognized internationally. https://www.accessforallconference.com/program https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32012L0013 https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB3254 https://droitsquotidiens.design/

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Episode 67: Access For All: Plain Language

DGT Academy - Radio Lingvistika

Play Episode Listen Later Nov 24, 2020 35:47

James Archibald(McGill University) discusses the key findings of a conference held mid October. Is language a condition to enjoy one's rights effectively? What if we were all concerned? More about the project to have a language-neutral plain language standard recognized internationally. https://www.accessforallconference.com/program https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32012L0013 https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB3254 https://droitsquotidiens.design/

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Episode 67: Access For All: Plain Language

DGT Academy - Radio Lingvistika

Play Episode Listen Later Nov 23, 2020 35:47

James Archibald(McGill University) discusses the key findings of a conference held mid October. Is language a condition to enjoy one’s rights effectively? What if we were all concerned? More about the project to have a language-neutral plain language standard recognized internationally. https://www.accessforallconference.com/program https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32012L0013 https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB3254 https://droitsquotidiens.design/

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S5E5: Grape Brandy Escape

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Play Episode Listen Later Nov 13, 2020 29:45

This is an overview of grape brandy around the world, and the different regions, production methods and styles. We distinguish the major grape brandy styles from those spirits made with other fruits, and the range of expressions from Grappa to long-aged brandies of the classic regions like Jerez, Cognac, and Armagnac. There are some fun historical facts and little known oddities extracted from US Code of Federal Regulations ... because your host is a big ol' corkdork. Resources from this episode: Books: Certified Specialist of Spirits Study Guide (Society of Wine Educators), Nickles, J., (2020) Distilling Knowledge: A professional guide to spirits and liqueurs (Wine and Spirits Education Trust) Broom, D., (2013) Grossman’s Guide to Wines Beers, and Spirits (7th Edition) Grossman, H., (Revised by Harriett Lembeck), (1983) Websites: Brandy De Jerez https://www.brandydejerez.es/en/enjoyment Charles Neal Selections: Armagnac http://www.charlesnealselections.com/armagnac1.html Charles Neal Selections: Cognac http://www.charlesnealselections.com/cognac.html Cornell Law School: Electronic Code of Federal Regulations (eCFR), Title 27 Section 5.22 - The Standards of Identity (d) Class 4; brandy. https://www.law.cornell.edu/cfr/text/27/5.22 Difford’s Guide: Grappa https://www.diffordsguide.com/beer-wine-spirits/category/380/grappa EUR-Lex (Access to European Union Law): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0110 Germain-Robin https://www.germain-robin.com/our-story San Francisco Gate: Over a Barrel - Germain-Robin makes superb brandies, yet they’re hard to sell, Gray, (2012) https://www.sfgate.com/wine/article/OVER-A-BARREL-Germain-Robin-makes-superb-2735377.php Podcast Episodes: S2E3: Apple Brandy - Domestic Happiness https://glassinsession.libsyn.com/s2e3-apple-brandy-domestic-happiness S3E5: Wine & Oxygen from Grapes to Glass https://glassinsession.libsyn.com/s3e5-wine-oxygen-from-grapes-to-glass S4E6: Got Wood? Talkin’ ‘bout Oak https://glassinsession.libsyn.com/s4e6-got-wood-talkin-bout-oak Wine Two Five: Pisco Unpacked https://podcasts.apple.com/us/podcast/pisco-unpacked/id986650051?i=1000397336490 Glass in Session® is a registered trademark of Vino With Val, LLC. Music: Addict Sound (Jamendo.com cc_Standard License, Jamendo S.A.)

Do Covid 19 Measures Undermine Democracy

Drumkoon Handpan Podcast

Play Episode Listen Later Nov 7, 2020 12:27

Question: Do Covid 19 measures and restrictions undermine Democratic rights like freedom of movement, freedom of association and freedom of expression ? #Democracy #Covid19 #CovidandDemocracy #Drumkoon #Lockdown #Denmark #Greece #Europe #HumanRights #BasicFreedoms Sources: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012P/TXT --- Send in a voice message: https://anchor.fm/drumkoon-handpan/message

LIVE episode! To CBDC or not to CBDC, what was the question?

Fintech Daydreaming

Play Episode Listen Later Nov 6, 2020 31:23

In this special episode of Fintech Daydreaming we were recording with a live audience for the very first time in our show's short history. To add to the excitement our fantastic guest Johanna Lybeck from Nordea gave us an economist perspective into central bank digital currencies and more. Did our hosts, Pål Krogdahl and Ville Sointu make it out of the live recording without major injuries? Did the audience in virtual attendance react to the attempted abysmal banking humor? All this and more in this week's episode. Guest: Johanna Lybeck, Executive Advisor, Nordea (https://www.linkedin.com/in/johanna-lybeck-lilja-09300428/) Links mentioned in the episode: - Avant Cash, the 90s era central bank digital currency: https://davidgerard.co.uk/blockchain/2020/01/25/avant-card-a-central-bank-digital-currency-from-1990s-finland/ - The Digital Euro paper by ECB: https://www.ecb.europa.eu/euro/html/digitaleuro.en.html - European Commission proposal for crypto asset regulation (MiCA): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020PC0593 - Fintech Daydreaming on Twitter - https://twitter.com/FintechDaydream - Fintech Daydreaming on LinkedIn - https://www.linkedin.com/company/fintech-daydreaming - Pål Krogdahl - https://www.linkedin.com/in/krogdahl/ - Ville Sointu - https://www.linkedin.com/in/ville-sointu-54682b/

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S5E3: Liqueur Lexicon

Safety With Purpose Podcast

Play Episode Listen Later Oct 9, 2020 20:48

Is liqueur just a fancy word for liquor? What’s the difference between a liqueur and a cordial? How are they made, and what the heck am I supposed to do with all of these bottles? We go there in this episode which is all about the sweetened, flavored spirits sitting around on your liquor shelf. Resources from this episode: Books: Certified Specialist of Spirits (CSS) Study Guide (Society of Wine Educators), Nickles, J., (2020) Grossman’s Guide to Wines Beers, and Spirits (7th Edition) Grossman, H., (Revised by Harriett Lembeck), (1983) Websites: Bar None Drinks https://www.barnonedrinks.com/drinks/by_ingredient/b/benedictine-189.html Bénédictine https://www.benedictinedom.com/ Cornell Law School: Electronic Code of Federal Regulations (eCFR), Title 27 Section 5.22 - The Standards of Identity (h) Class 8; cordials and liqueurs. https://www.law.cornell.edu/cfr/text/27/5.22 Daily Beast: Lessons from the Virtual Bar, Wondrich (2020) https://www.thedailybeast.com/lessons-from-the-virtual-bar EUR-Lex (Access to European Union Law): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0110 Liquor.com https://www.liquor.com/recipes/vieux-carre/ Glass in Session® is a registered trademark of Vino With Val, LLC. Music: Addict Sound (Jamendo.com cc_Standard License, Jamendo S.A.)

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ST#5 – Noise Exposure: Evolving Legislation and Recent Court Actions with Andrew McNeil

Play Episode Listen Later Nov 26, 2019 32:02

In this episode Patrick chats with Andrew McNeil about the impact of noise-related legislation and the outcomes of recent court cases that are game changers in terms of managing noise at source. Andrew talks first about hearing, the function of listening and the incredible sensitivity of the human ear. Andrew describes the evolving regulatory framework for noise control in workplaces and the duty of care employers that employers are required to meet. We chat about cases studies where significant hearing loss was sustained from workplace exposures, including a unique case of acoustic shock syndrome, that resulted in a significant monetary award to the injured employee. Control of noise at source is a legislated requirement that employers need to be mindful of before PPE and other, less effective, controls are considered. Sound and vibration identification and damping technologies are advancing rapidly. These technologies are further sustained by a variety of consultancy and workplace analysis services that assist employers when investing in noise control methods. Andrew is Managing Director of McNeil Collective a new breed of health and safety consultancy. You’ll find more information about Andrew and his organization at www.McNeilcollective.com (http://www.McNeilcollective.com) Andrew on Linkedin: https://www.linkedin.com/in/andrew-mcneil?lipi=urn%3Ali%3Apage%3Ad_flagship3_profile_view_base_contact_details%3BRUggv7oKTxisQdGXgzX0oA%3D%3D (https://www.linkedin.com/in/andrew-mcneil?lipi=urn%3Ali%3Apage%3Ad_flagship3_profile_view_base_contact_details%3BRUggv7oKTxisQdGXgzX0oA%3D%3D) Resources for this episode: The Court of Appeal judgment in Goldsheider: https://www.judiciary.uk/wp-content/uploads/2019/04/goldscheider-v-roh-judgment.pdf (https://www.judiciary.uk/wp-content/uploads/2019/04/goldscheider-v-roh-judgment.pdf) The Guardian news paper report on that: https://www.theguardian.com/culture/2018/mar/28/viola-player-wins-royal-opera-house-case-for-hearing-damage (https://www.theguardian.com/culture/2018/mar/28/viola-player-wins-royal-opera-house-case-for-hearing-damage) The European Union directive 2003/10/EC on noise: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32003L0010 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32003L0010) OSHA Technical Manual on noise: https://www.osha.gov/dts/osta/otm/new_noise/#standards (https://www.osha.gov/dts/osta/otm/new_noise/#standards) OSH Noise limits for Canada: https://www.ccohs.ca/oshanswers/phys_agents/exposure_can.html (https://www.ccohs.ca/oshanswers/phys_agents/exposure_can.html) Really useful guidance on reducing noise at source from the UK Health and Safety Executive (that is also referred to in the OSHA Technical guide above): http://www.hse.gov.uk/noise/casestudies/soundsolutions/index.htm (http://www.hse.gov.uk/noise/casestudies/soundsolutions/index.htm) Noise limits in the UK: http://www.legislation.gov.uk/uksi/2005/1643/regulation/4/made (http://www.legislation.gov.uk/uksi/2005/1643/regulation/4/made) Sound Dead Steel that can be used to cut noise from impact or vibration of panels (amazing product): http://www.sounddeadsteel.com/ (http://www.sounddeadsteel.com/) Noise cancelling lightweight panels also amazing: https://www.sonobex.com/ (https://www.sonobex.com/) Motion Amplification Technology from RMS Ltd showing sources of vibration visually: https://www.youtube.com/watch?v=qnHZ6A5N_E0 (https://www.youtube.com/watch?v=qnHZ6A5N_E0) Institute of Acoustics, real experts in industrial noise problems and solutions who will be pleased to engage on sources of noise and how to reduce noise at source: https://www.ioa.org.uk/ (https://www.ioa.org.uk/)

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17: Edinburgh Festivals and The European Union

School Britannia

Play Episode Listen Later Sep 4, 2019 59:06

Episode 17 of School Britannia Podcast, a fortnightly show serving you British History gems from the perspective of two Aussie upstarts. Why is Edinburgh such a popular festival spot? And how did Britain become part of a united Europe? Ellie is back to tell you all about it, and more! Editing by Claire www.clairegawne.com Artwork by Lucy Maddox www.lucymaddox.com Sources: https://www.edinburghfestivalcity.com/the-city/history-of-the-festivals https://www.theskinny.co.uk/comedy/opinion/how-comedy-captured-the-edinburgh-fringe-part-1 https://www.edfringe.com/learn/news-and-events/record-edinburgh-audiences-as-fringe-comes-to-a-close https://en.wikipedia.org/wiki/World_War_II_casualties https://en.wikipedia.org/wiki/Bruno_Walter http://www.primaryhomeworkhelp.co.uk/war/blitz.htm https://www.scotsman.com/lifestyle-2-15039/culture/edinburgh-festivals/brexit-could-have-a-disastrous-impact-on-edinburgh-international-festival-1-4776482 https://www.conventionedinburgh.com/edinburgh/get-to-know-edinburgh/creative-capital/ https://europa.eu/european-union/about-eu/history_en https://en.m.wikipedia.org/wiki/Council_of_Europe https://www.cvce.eu/obj/the_new_european_parliament-en-e40aba1b-45f1-43bf-bbd1-a34bb52f15db.html https://en.m.wikipedia.org/wiki/European_Union https://europa.eu/european-union/sites/europaeu/files/docs/body/winston_churchill_en.pdf https://en.m.wikipedia.org/wiki/European_Coal_and_Steel_Community https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM:xy0026

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04 - Příští zastávka, Downing Street aneb britské odcházení

Za Humny podcast

Play Episode Listen Later Jul 28, 2019 35:00

Tři roky, tři premiéři, tři ministři pro brexit, jeden červený brexitový autobus - jen ten brexit pořád nikde. Co se v Británii vlastně děje a jak je možné, že už druhou kolébku demokracie vede blonďák, co si tak trochu do úst nevidí? Podíváme se nejenom na milníky posledních tří let, navíc se pokusíme rozkrýt, co referendum udělalo s celým britským politickým systémem (spoiler: nic dobrého). A taky, co má s brexitem společného Benedict Cumberbatch. Jedna aktualizační poznámka: na konci mluvíme o tom, že Boris Johnson by si asi nepřál předčasné volby, protože pokud jeho plány nepůjdou jako po másle, riskuje ještě další odliv hlasů k Brexit Party. Mezitím ale stihl povyházet 17 lidí z kabinetu (nebo sami odešli) a v jeho nové vládě sedí plno zastánců tvrdého brexitu. To znamená, že je na nové volby docela dobře připraven, a už se i šušká, že by je mohl vyhlásit 24. října, týden před osudným brexitovým datem, aby mu voliči "dali" parlament, který odsouhlasí no deal nebo aby ho protlačil v momentě, kdy se budou poslanci "střídat". Ale to je všechno ještě ve hvězdách, důležité je, že předčasné volby by pro Johnsona nemusela být taková pohroma a on se na ně podle jeho posledních kroků vědomě připravuje. A vůbec, do té doby, než tenhle díl slyšíte, je určitě jinak spoustu dalších věcí. Zdroje a odkazy: Konsolidované smlouvy o EU a fungování EU: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A12012M%2FTXT Dohoda o vystoupení a politická deklarace: https://www.gov.uk/government/publications/withdrawal-agreement-and-political-declaration Spousta užitečných explainers na BBC: https://www.bbc.com/news/politics/uk_leaves_the_eu Ekonomická předpověď no deal: https://www.theguardian.com/business/2019/jul/18/no-deal-brexit-would-plunge-britain-into-a-recession-says-obr Proč Cameron měl naději, že referendum nebude muset vypsat: https://www.theguardian.com/world/2019/jan/21/donald-tusk-warned-david-cameron-about-stupid-eu-referendum-bbc O Borisovi: https://www.washingtonpost.com/world/europe/boris-johnson-britains-likely-next-prime-minister-is-a-hack--a-journalist-who-has-reached-the-pinnacle-of-power/2019/07/20/0fff5146-a98d-11e9-8733-48c87235f396_story.html?utm_term=.cb75627625f5 Brexit: The Uncivil War: https://www.imdb.com/title/tt8425058/ Naše o mnoho vzdělanější konkurence k podobnému tématu: https://www.talkingpoliticspodcast.com/blog/2019/173-waiting-for-boris https://www.talkingpoliticspodcast.com/blog/2019/156-brexit-lessons

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EU Treaties: Title 1 Article 3

european union original treaties en txt

Play Episode Listen Later Jul 28, 2019 13:30

Original text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012M/TXT

EU Treaties: Title 1 Articles 1-2

european union original treaties en txt

Play Episode Listen Later Jul 21, 2019 7:39

Original text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012M/TXT

EU Treaties: Preamble

european union original preamble treaties en txt

Play Episode Listen Later Jul 14, 2019 14:38

Original text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012M/TXT

Actual GDPR text (part 1)

Play Episode Listen Later Jun 2, 2019 11:41

Original text: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1559213645525&uri=CELEX:32016R0679

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EU regulations in general