Podcasts about regulatory

Photo: No known restrictions on publication. @Batchelorshow #Preview: #SpecialEdition: Imagining the regulatory state for private space stations. Rand Simberg, author, "Safe Is Not an Option."   

(0:00) Bestie intros!: Reddit Performance Reviews (5:14) Quick AIS 2023 update (6:27) AI Senate hearing: Sam Altman playing chess with regulators, open-source viability (21:25) Regulatory capture angle, "preemptive regulation," how AI relates to nuclear, insider insights from the White House's AI summit (43:33) Elon hires new Twitter CEO (48:46) Lina Khan moves to block Amgen's $27.8B acquisition of Horizon Therapeutics (1:02:30) Apple's AR goggles are reportedly being unveiled at WWDC in early June, platform shift potential, how it deviates from Apple's prior launch strategies (1:07:45) Residential and commercial real estate headwinds (1:15:29) Unrest in SF and NYC after two recent tragic incidents ended in death (1:24:20) Soros political motivations for backing progressive DAs Follow the besties: https://twitter.com/chamath https://linktr.ee/calacanis https://twitter.com/DavidSacks https://twitter.com/friedberg Follow the pod: https://twitter.com/theallinpod https://linktr.ee/allinpodcast Intro Music Credit: https://rb.gy/tppkzl https://twitter.com/yung_spielburg Intro Video Credit: https://twitter.com/TheZachEffect Referenced in the show: https://techcrunch.com/2023/05/18/psst-gary-marcus-is-happy-to-help-regulate-ai-on-behalf-of-the-u-s-government/ https://twitter.com/chamath/status/1658913074106236931 https://www.mosaicml.com/blog/mpt-7b https://huggingface.co/spaces/HuggingFaceH4/open_llm_leaderboard https://artificialintelligenceact.eu https://futurism.com/the-byte/warren-buffett-ai-atom-bomb https://www.cnbc.com/2023/05/12/nbcuniversal-ad-chief-yaccarino-resigns-as-sources-say-shes-in-talks-to-be-twitter-ceo.html https://www.wsj.com/articles/ftc-poised-to-block-amgens-27-8-billion-deal-for-horizon-therapeutics-a9c1b499 https://www.ftc.gov/system/files/ftc_gov/pdf/2310037amgenhorizoncomplainttropi.pdf https://www.benefitspro.com/2023/05/12/pbms-the-brokers-who-control-drug-prices-finally-get-washingtons-attention https://sharegpt.com/c/O6OKM9D https://www.wsj.com/articles/apple-mixed-reality-headset-9213ac1b https://twitter.com/PalmerLuckey/status/1657828947877560323 https://twitter.com/DavidSacks/status/1658955195450286081 https://www.foxnews.com/us/witness-jordan-neely-chokehold-death-calls-daniel-penny-hero https://www.reddit.com/r/nyc/comments/1njfls/try_to_stay_away_from_the_michael_jackson https://en.wikipedia.org/wiki/1984_New_York_City_Subway_shooting https://en.wikipedia.org/wiki/Guardian_Angels https://www.messynessychic.com/2019/03/26/in-the-shadows-with-nycs-self-styled-guardian-angels https://www.eviemagazine.com/post/media-falsely-representing-jordan-neely-10-year-old-photos-crucial-information https://twitter.com/Jason/status/1655716240500080640 https://www.foxnews.com/politics/george-soros-son-visited-white-house-dozen-times-since-biden-took-office-records-show

With slowing regional bank turmoil, all eyes shifted to the debt ceiling deal debate. In this week's episode, we examine the latest economic news. Mike Flood of the Mortgage Bankers Association shares his perspective on the debt ceiling and bank regulation. In CRE, we saw several office loans transfer to special servicing, sublease stories, and comps. We also share retail green shoots and crabgrass, a hotel comeback story, and discuss our bank CRE concentration analysis. And in an ode to Sam Zell, we reference his mentality of knowing when to “hold ‘em” and when to “fold ‘em.” Tune in now. Episode Notes: • Economic update(0:23) • Debt ceiling thoughts: Mike Flood, MBA (6:45) • Bank executive testimonials (9:35) • Regulatory changes ahead (11:01) • Bank CRE concentrations (15:14) • Office special servicing transfers (18:19) • Sublease stories (24:10) • Office comps (27:58) • Retail crabgrass (30:02) • Retail green shoots (33:35) • Hotel comeback story(36:12) • Shoutouts (38:51) Questions or comments? Contact us at podcast@trepp.com. Follow Trepp: Twitter: www.twitter.com/TreppWire LinkedIn: www.linkedin.com/company/trepp Facebook: www.facebook.com/TreppLLC

OPEN MIKE w/Michael Thiessen ~ May 11, 2023 On this week's episode of OPEN MIKE, Mike is joined by Canadian Covid Care Alliance (CCCA) clinical researcher Deanna McLeod, founder of Kaleidoscope Strategic and Covid Sense, this time to talk about how our government has partnered with industry to help them circumvent the safety barriers put in place to protect Canadians from harm. Episode Resource: Canadian COVID Care Alliance: https://www.canadiancovidcarealliance.org/; SUPPORT FOR HAROLD JONKER'S DEFENCE FUND: https://givesendgo.com/TruckersLegalSupport?utm_source=sharelink&utm_medium=copy_link&utm_campaign=TruckersLegalSupport; Support Josh's Stand and Help Us Defend His Liberties! Sign Our Petition Here: https://libertycoalitioncanada.com/i-stand-with-josh-alexander/;MAILBAG QUESTIONS: If you want your question featured on the show, message mailbag@libertycoalitioncanada.com;SHOW SPONSORS:Join Red Balloon Today!: https://www.redballoon.work/lcc;Invest with Rocklinc: info@rocklinc.com or call them at 905-631-546;Diversify Your Money with Bull Bitcoin: https://mission.bullbitcoin.com/lccSick of Mainstream Media Lies? Help Support Independent Media! DONATE TO LCC TODAY!: https://libertycoalitioncanada.com/donate/ Please Support us in bringing you real, truthful reporting and analysis from a Christian perspective.SUBSCRIBE TO OUR SHOWS/CHANNELS:LIBERTY DISPATCH PODCAST: https://libertydispatch.podbean.com; https://rumble.com/LDshow; OPEN MIKE WITH MICHAEL THIESSEN: https://openmikewithmichaelthiessen.podbean.com; https://rumble.com/openmike;THE OTHER CLUB: https://rumble.com/c/c-2541984; THE LIBERTY LOUNGE WITH TIM TYSOE: https://rumble.com/LLwTT;CONTACT US:Questions/comments about podcasts/news/analysis: mailbag@libertycoalitioncanada.com;Questions/comments about donations: give@libertycoalitioncanada.com;Questions/comments that are church-related: churches@libertycoalitioncanada.com;General Inquiries: info@libertycoalitioncanada.com. STAY UP-TO-DATE ON ALL THINGS LCC:Gab: https://gab.com/libertycoalitioncanada Telegram: https://t.me/libertycoalitioncanadanews Instagram: https://instagram.com/libertycoalitioncanada Facebook: https://facebook.com/LibertyCoalitionCanada Twitter: @LibertyCCanada - https://twitter.com/LibertyCCanada Rumble: https://rumble.com/user/LibertyCoalitionCanada YouTube: https://www.youtube.com/@liberty4canada Please LIKE, SUBSCRIBE, RATE & REVIEW and SHARE it with others!

When can a federal regulatory agency nix your right to a jury trial and instead subject you to their own internal court? That's a question now moving through the courts. Cato's Tommy Berry describes the case of Burgess v. Whang. Hosted on Acast. See acast.com/privacy for more information.

On Episode 25 of the TID Water & Power Podcast we sit down with TID Regulatory Analysts, Herb Smart and Austin Avery, to discuss the regulatory process. We know how bills become laws, but what happens next? The law then goes through a regulatory process that determines HOW it will be implemented. Tasked with tracking this process and the potential positive and negative impacts of each regulation are TID's Regulatory Analysts, who are working to ensure the District, and its customers, are protected from unfair regulations. On this episode we discuss the role of a regulatory analyst, how regulations and the regulatory process impact the District, and some of the key regulatory proceedings they are tracking now.  Let's get social! Facebook: @TurlockIDInstagram: @TurlockIDTwitter: @TurlockIDLinkedIn: /company/turlockid Find out more about TID at https://www.TID.org/podcast.

With the recent bank failures, many people and businesses throughout the U.S. are wondering what the future may hold for the banking industry. That's why we're talking with Sayee Srinivasan, Chief Economist and Head of Research for the American Bank Association. Hear what he had to say about the state of the banking sector, the importance of micro vs. macro trends, why businesses should build a relationship with their bank, FDIC coverage, and much more. Topics Include: 00:00 – Welcome, Sayee Srinivasan 00:58 – Introduction to the American Bank Association 05:25 – The economy based on banking data 07:39 – Micro vs macro trends 09:27 – Should we be worried about the banks? 11:08 – The state of the banking system 12:11 – Building a relationship with your bank 14:32 – Questions you should be asking 16:32 – Regulatory requirements 17:56 – Finding data on banks 19:12 – FDIC coverage 23:14 – Competitive non-bank entities 26:19 – Interest rate outlook 30:53 – Wrap up Have a guest or topic you'd like to suggest for the show? Submit your ideas at https://pages.paychex.com/business-podcast-requests.html. DISCLAIMER: The information presented in this podcast, and that is further provided by the presenter, should not be considered legal or accounting advice, and should not substitute for legal, accounting, or other professional advice in which the facts and circumstances may warrant. We encourage you to consult legal counsel as it pertains to your own unique situation(s) and/or with any specific legal questions you may have.

Wes Morris, Senior Director, Consulting Services, Clearwater, speaks with Bethany Corbin, an attorney who provides strategic guidance and legal counsel to health care innovation companies and Femtech, about the challenges health care organizations face when attempting to comply with different regulatory frameworks and strategies for compliance related to data privacy. They discuss the HIPAA Privacy Rule, 42 C.F.R. Part 2, and the Information Blocking Rule; navigating the conflicting data privacy structures; how HHS is seeking to harmonize certain privacy requirements; strategies for compliance; and the future of data privacy. Bethany recently authored an AHLA Briefing related to this topic. From AHLA's Hospitals and Health Systems and Health Information and Technology Practice Groups. Sponsored by Clearwater.To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

Dr. Jon Oatley, associate dean for research for the College of Veterinary Medicine and a professor at Washington State University discusses advances in gene-editing in livestock, a technique that alters an animal's genetic code to focus on desired traits. His team recently received U.S. Food and Drug Administration investigational authorization to create food for humans from gene-edited pigs in a process that is akin to traditional selective breeding. Gene-editing also could play an important role in meeting the growing global demand for protein over the next few decades.

Your medical staff office just notified you that a physician has been performing procedures without privileges for the past five years.No, it doesn't happen all the time. But what should you do?Physician and attorney Dr. John K. Hall will walk you through the considerations and help you understand how much revenue might be in jeopardy during the next live edition of Monitor Mondays.Broadcast segments will also include these instantly recognizable features:Monday Rounds: Ronald Hirsch, vice president of R1 RCM, will be making his Monday Rounds.The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullen, will report the latest news about auditors.Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Bryon, will join the broadcast with his trademark segment.Legislative Update: Folana Houston, assistant general counsel for Zelis, will report on current healthcare legislation.The Wrapper: John Zelem, founder and CEO of Streamline Consulting Solutions, will join the broadcast for a wrap-up on the morning's top stories.& so much moreA bi-monthly podcast where we share the stories of our Caregivers, patients and...Listen on: Apple Podcasts Spotify

XRP - When Regulatory Clarity in US? Does Price Keep Dropping Without It? *SUPPORT ON THE CHAIN* JOIN THE CHANNEL https://otc.one/join OTC MERCH https://onthechain.shop BUY US A COFFEE https://otc.one/buy-us-a-coffee Support ON THE CHAIN https://otc.one/support -------------- *ON THE CHAIN* SUBSCRIBE TO THE OTC PODCAST: https://otc.one/podcast Subscribe to our other Youtube Channel: https://otc.one/onthechain On The Web: https://onthechain.io Follow OTC on Twitter: https://otc.one/otc Join On The Chain Community on Twitter https://twitter.com/i/communities/1599435678995062788 Join our FREE Telegram Roundtable channel: https://t.me/onthechain_roundtable -------------- *JEFF* Follow Jeff on Twitter: https://otc.one/jeff -------------- *CHIP* Follow Chip on Twitter: https://otc.one/chip Listen to Chip's music http://nojoyyet.com​ -------------- *DISCLAIMER:* _All opinions expressed by content contributors that appear on OTC are solely expressing their opinions and do not reflect the opinions of OTC, its affiliates, or sponsors. Content contributors may have previously disseminated information on a social media platform, website, or another medium such as a podcast, television, or radio. OTC, Content Contributors, Affiliates, or Sponsors are not obligated to update or correct any information. The content contributors are sharing the information which they believe to be reliable. OTC, its affiliates, or sponsors cannot guarantee the accuracy of the opinion shared, and viewers, readers, and listeners should not rely on it. Opinions expressed are not financial advice. Please consult a licensed financial advisor before making any financial decisions. You must research before you invest in anything. Do not invest based on what someone else is doing or not doing, or based on other people's opinions._ #XRP #Ripple #cryptocurrency #news

Dr. Tanya Altmann, FAAP, a UCLA-trained pediatrician talks with Michelle about the importance of play. Experts agree, play is an integral component to a child's development, as it builds important social and emotional skills. According to a recent study, due to COVID, kids are redefining the way they want to play, including seeking a safe space to play and the permission to say YES to play more. Yet where kids see fun and an opportunity to explore, parents can look at the same thing and see dirty surfaces, limiting kids' freedom to play. This has uncovered a play gap between the way kids want to experience play and how parents are helping to facilitate it. To help close this gap, the FamilyGuard™ Brand is introducing YES, PLAY!, a new initiative that highlights the importance of having a dedicated, clean play space in the home, while giving parents the tools they need to be successful in today's state of family play. Last year over 100,000 Americans died after overdosing on opioids, including prescription pain medications. Rates of prescription drug abuse in the U.S. are alarmingly high, as are the number of accidental poisonings and overdoses due to these drugs. Ashley Schmidt is the VP of Regulatory and Compliance at Inmar Intelligence and talks about National Prescription Drug Take Back Day, their drug disposal program and how people can get involved locally.When school breaks for summer, many kids want a break from everything! It's tempting to trade in alarm clocks, homework and gym class for sleeping late, screen time and snacking on sugary summer treats – but it's obviously not in kids' best interest, physically or mentally.The Society of Behavioral Medicine reports that physical activity for children between 6 and 9 years old drops by 53% during summer break, resulting in weight gain and bad eating habits. And the lack of stimulation leads to ‘summer learning loss,' a phenomena where kids lose academic skills, like reading and math.But the struggle to keep kids entertained, engaged and eating well for three months is real for parents! Fortunately, they're getting an assist. Who better to inspire kids to get off the bench and take a swing at adopting healthier habits than a woman who managed the diets of Chicago Cubs players for a decade?Registered Dietitian Nutritionist, Dawn Jackson Blatner, has teamed up with Eggland's Best to develop a game plan for motivating kids to stay active and eat healthy during their summer break and beyond! And first base is the YMCA's nationwide Healthy Kids Day® event on April 29th, an opportunity for families to get active, have fun and jumpstart a healthy summer.Kathleen Ashmore is a professional chef and recipe developer. In today's often hectic lifestyle, it can be hard to find better-for-you options while on the go. Smoothie bowls are an on-trend solution to keep you energized while you tackle the day ahead. Packed with premium ingredients and whole fruits, smoothie bowls can be incredibly nutrient- and protein-dense, especially if they include superfoods like açaí or pitaya, commonly known as dragon fruit.To meet the growing demand for healthier and more satisfying options on-the-go, Smoothie King – the first company to bring smoothies to the masses – launched a new product lineup, the Smoothie Bowl.

Several government departments, consultations, and decisions are converging to clear a path for gene-editing technology to be approved as a breeding technique for conventional crops. That’s right, if the last hurdle can be cleared — approval of gene-edited plants for livestock feed — a variety or cultivar produced with gene-editing techniques would be considered non-novel... Read More

•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf • MDCG planning available :https://health.ec.europa.eu/system/files/2023-04/md_events_2023_en_1.pdf •TEAM-NB position paper : https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419.pdf •Finland - Electronic Submission for Medical Devices :https://www.fimea.fi/web/en/-/electronic-submissions-for-medical-devices-will-be-opened-on-2-may-2023 •France- Digital Medical Application reimbursement :https://esante.gouv.fr/espace-presse/lancement-de-la-prise-en-charge-anticipee-des-dispositifs-medicaux-numeriques • Switzerland - IVD performance studies : 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 •Switzerland – IMDRF OFFICIAL OBSERVER :https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissmedic-official-observer-imdrf.html • UK - Transition from CE to 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 • Training EU MDR :https://school.easymedicaldevice.com/course/gb25  USA: Draft guidance on PCCP for AI/ML :https://www.fda.gov/media/166704/download o USA: Radiation Sterilization Master File Pilot Program :https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program. o Australia: Regulation for software based medical devices :https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices o China: Guideline for Medical Device :https://www.cmde.org.cn/xwdt/zxyw/20230404163902154.html o India: List of Notified Bodies registered in India : o Mexico, Colombia & Cuba sign the Acapulco Declaration : https://www.gob.mx/cofepris/articulos/se-firma-declaracion-de-acapulco-para-creacion-de-la-agencia-reguladora-de-medicamentos-y-dispositivos-medicos-de-latinoamerica-y-el-caribe?idiom=es oSaudi Arabia Webinars : •May 9, 2023 Guidance on Medical Devices Classification https://www.sfda.gov.sa/en/workshop/88229 •May 22, 2023 Product Sterilization Requirements for Medical Devices https://www.sfda.gov.sa/en/workshop/88228 oPodcast Nostalgia •Episode 227: What is a SOUP for your Software Development Christian Kaestner Medical Device HQ https://podcast.easymedicaldevice.com/227-2/ •Episode 228: Prepare your Audit like a PRO with Karandeep Badwal https://podcast.easymedicaldevice.com/228-2/ •Episode 229: Transition to Agile for Software as Medical Device: https://podcast.easymedicaldevice.com/229-2/ 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

This week: SCOTUS is set to hear a case that may not be sexy but could have major consequences for the government's ability to regulate industries; Tacopina looks like a bully in Trump's rape/defamation case brought by E. Jean Carroll; plus a little bit of sports for non-sports fans. Youtube:  https://www.youtube.com/@Its.Complicated/ Subscribe to our podcast  https://link.chtbl.com/its-complicated Follow Asha on Twitter: https://twitter.com/AshaRangappa_ Asha's Substack: https://asharangappa.substack.com/ Follow Renato on Twitter: https://twitter.com/renato_mariotti Follow Asha on Instagram: https://www.instagram.com/asha.rangappa/ Follow Renato on Instagram: https://www.instagram.com/renato.mariotti/ Learn more about your ad choices. Visit megaphone.fm/adchoices

A broad index of bank shares dropped 9% this week; Banking lobby calls for investigation of short selling; Some on Wall Street want all bank deposits insured to stem crisis of confidence - May 5, 2023 To learn more about listener data and our privacy practices visit: https://www.audacyinc.com/privacy-policy Learn more about your ad choices. Visit https://podcastchoices.com/adchoices

This episode is sponsored by EY.On this episode of “Money Reimagined,” Michael Casey and Sheila Warren have a summation of, as Sheila calls it a ‘Consensus Hootenanny'; Consensus 2023. Through its Consensus 2023 app, Coindesk surveyed its attendees about their opinions on the state of crypto. Casey and Warren go right to the heart of most attendees' concerns about regulation and policy for crypto and the implications for the SEC. Coindesk Conference, Consensus2023 Consensus Hootenanny Results 1:01Annual conference held in Texas.Conference circuit is back in full play.Survey results, regulation, policy and public image.Global survey results are healthier.Regulation and policy are moving to the forefront. 3:49Regulation and policy moving to the forefront in the fintech space.Fintech vs crypto.Crypto and the implications for the SEC.The role of the judiciary.Regulation and policy is essential in the crypto industry.The battle of the age.What is the government's role in regulation? 9:57Other governments and regulators are ahead of us.Dysfunction in the US legislature.The checks and balances of a functioning system.The activist supreme court and judiciary system.The role of experts in the CFTC. 14:45Expert selection and tenure of the leadership.The idea of chevron deference.Crypto is getting caught up in the litigation.Grayscale lawsuit against crypto companies.Impact litigation and how it impacts the law. 18:57Impact litigation is a bigger minefield than traditional litigation.Low-c conservatives and activist judges.Regulation and policy are top of mind in the United States.Regulation in the crypto industry.How should crypto companies respond to recent regulatory actions? 22:56How US companies should respond to recent regulatory actions.Us-based businesses vs non-us-based firms.Regulation is a big reason why companies choose to locate in the US.Regulatory clarity.Regulation and Regulation. 27:00Regulators have won the battle for the crypto industry.The challenges of KYC.More people are coming around to the idea of regulation as a catalyst for growth.The importance of regulation in the United States.From our Sponsor: EY blockchain solutions can transform the business lifecycle for digital ecosystems, by promoting trust, transparency, privacy and efficiency. EY: Helping you build a better working world. Find out more at blockchain.ey.com-Money Reimagined has been produced and edited by senior producer Michele Musso and our executive producer is Jared Schwartz. Our theme song is “AITA” by Neon Beach.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

This episode is sponsored by EY.On this episode of “Money Reimagined,” Michael Casey and Sheila Warren have a summation of, as Sheila calls it a ‘Consensus Hootenanny'; Consensus 2023. Through its Consensus 2023 app, Coindesk surveyed its attendees about their opinions on the state of crypto. Casey and Warren go right to the heart of most attendees' concerns about regulation and policy for crypto and the implications for the SEC. Coindesk Conference, Consensus2023 Consensus Hootenanny Results 1:01Annual conference held in Texas.Conference circuit is back in full play.Survey results, regulation, policy and public image.Global survey results are healthier.Regulation and policy are moving to the forefront. 3:49Regulation and policy moving to the forefront in the fintech space.Fintech vs crypto.Crypto and the implications for the SEC.The role of the judiciary.Regulation and policy is essential in the crypto industry.The battle of the age.What is the government's role in regulation? 9:57Other governments and regulators are ahead of us.Dysfunction in the US legislature.The checks and balances of a functioning system.The activist supreme court and judiciary system.The role of experts in the CFTC. 14:45Expert selection and tenure of the leadership.The idea of chevron deference.Crypto is getting caught up in the litigation.Grayscale lawsuit against crypto companies.Impact litigation and how it impacts the law. 18:57Impact litigation is a bigger minefield than traditional litigation.Low-c conservatives and activist judges.Regulation and policy are top of mind in the United States.Regulation in the crypto industry.How should crypto companies respond to recent regulatory actions? 22:56How US companies should respond to recent regulatory actions.Us-based businesses vs non-us-based firms.Regulation is a big reason why companies choose to locate in the US.Regulatory clarity.Regulation and Regulation. 27:00Regulators have won the battle for the crypto industry.The challenges of KYC.More people are coming around to the idea of regulation as a catalyst for growth.The importance of regulation in the United States.From our Sponsor: EY blockchain solutions can transform the business lifecycle for digital ecosystems, by promoting trust, transparency, privacy and efficiency. EY: Helping you build a better working world. Find out more at blockchain.ey.com-Money Reimagined has been produced and edited by senior producer Michele Musso and our executive producer is Jared Schwartz. Our theme song is “AITA” by Neon Beach.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this episode of Medsider Radio, we sat down with Waqaas Al-Siddiq, CEO of Biotrocity, a cutting-edge remote patient monitoring company focusing on the cardiac landscape. Waqaas has a dual Bachelor's degree in Computer Engineering and Economics, a Master's in Computer Engineering from Rochester Institute of Technology, and a Master's in Business Administration and a Doctorate in Business Administration from Henley Business School. With over 15 years of experience in the technology and healthcare sectors, Waqaas has a strong track record of developing innovative solutions for remote patient monitoring and connected health. As the CEO of Biotricity, he leads the company's mission to revolutionize remote patient monitoring by leveraging cutting-edge technology and data-driven insights.In this interview, Waqaas discusses the crucial role that passion and work ethic play in driving healthtech success. He shares valuable insights into understanding the needs of your target market for effective product development, as well as fostering a culture of continuous learning and improvement within your organization.Before we jump into the conversation, I wanted to mention a few things:If you're into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You'll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a MedTech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you're interested, go to medsider.com/subscribe to learn more.

This week's guest is Domingo Valadez, Co-founder & CEO of Homebase, a platform that lets people invest in tokenized residential real estate for as little as $100. As real estate prices continue to get more and more unaffordable for people, Homebase aims to be the destination for US renters to invest in the US residential real estate market via fractionalizing NFTs. Show Notes:0:50 - What is Homebase?2:05 - Why Solana?4:06 - How does it work?7:09  - Benefits using web3 and Solana9:17 - Us vs International11:11 - How things can evolve for Homebase?  14:18 - Regulatory landscape in the US / next US markets to expand to17:04 - User journey from first wallet to being a homeowner20:04 - Voting  21:14 -  Retaining people in Crypto    22:57 -  Exciting things in on-chain residential real estate.24:38 -  A builder Domingo admires in the Solana ecosystem Full Transcript:Brian Friel (00:05):Hey, everyone, and welcome to The Zeitgeist, the show where we highlight the founders, developers, and designers who are pushing the Web3 space forward. I'm Brian Friel, developer relations at Phantom, and I'm super excited to introduce my guest, Domingo Valadez, the co-founder of Homebase, a digital platform for fractionalizing residential real estate via NFTs. Domingo, welcome to the show. Domingo Valadez (00:28):Thanks so much for having me, Brian. Super excited to be here. Brian Friel (00:30):Yeah, super excited to have you on as well. You guys are a hotly anticipated recent launch. I've seen you guys on Twitter. It's one of the most, I'd say, unique and more pragmatic applications I've seen most recently launch on Solana. Can you give us a quick overview of what is Homebase and how can users start using it today? Domingo Valadez (00:51):Yeah. Homebase is a platform that lets people invest in tokenized residential real estate for as little as $100. The main value property right people is just getting exposure to an actual physical rental property and starting to get some of that passive income, starting to get that appreciation over time in terms of how you can participate and invest, you can just go to our website, make an account, we do force you to put a KYC and that's just to follow us regulations. So right now we're limited to just US investors unfortunately, but have plans to make it international as we continue to grow. But right now it's a matter of KYCing. You also have to set up a 15-minute call with one of my co-founders, Alex, and that's just to make sure that you're a sophisticated investor so you get to know us a little bit. So we're very transparent with our team and what we're doing, but we had 38 people participate in our very first home and now have 1500 that want to participate in our next one. Brian Friel (01:41):That's awesome. So residential real estate investing, that's something that I'd say a lot of the demographic with Solana maybe skews potentially on the younger side. This is something that people think is interesting but have historically been left out of this world of investing. What made you guys decide to do something in a purely digital way that's different than traditional residential real estate investing and what made you guys choose to launch this on Solana? Domingo Valadez (02:05):I grew up in a family that has always seen real estate as a great way building wealth over time and just growing up I've very quickly seen it become unaffordable for most people in my generation. So I was working at Google for five years, still couldn't afford anything in the Bay Area and I was like, "This is absurd." And so it was like how can we make this affordable for people where they can actually get some skin in the game with the properties they're living in? And so that was really a big culmination for why Homebase and so then I've invested in my own residential property, myself and my hometown of McAllen just going into that flow, so many third parties, how to work with a bank, took literally three months to buy the property and that was just awful as well. So it's kind of like what can we do that's completely digital that just makes the experience really, really easy for people? (02:49):And so that's where the idea around Homebase came from. We're making it where people can invest in properties for as little as a hundred dollars. And so real estate's also a industry that loves silo data. You have big players that really hold their data near and dear to their heart and don't want to share it, and that's the complete opposite of public blockchains, right? It's like, "Let's just get data. Everyone should have a fair shot at understanding what's going on and if you know how to utilize that data, you can make some great decisions with it." A big piece of it came from the mission as well of I've been following Bitcoin since 2017, love the decentralization aspect of it and so wanted to see how we could get real estate in a very transparent open source way. That was a big culmination about why even build in a digital space using blockchain to do this. Brian Friel (03:33):Love it. I think that story resonates with a lot of listeners potentially I myself in Bay Area. Similar story there, so it's similar frustrations. I guess I'm a little curious how does this at a high level work under the hood? Kind of back to my earlier question, a lot of folks maybe don't know much about real estate investing. There's a lot of paperwork involved. What role is Homebase playing? What parts of this are done on chain? How do I go from, "I'm just a normal crypto user with NFTs." To now, I can say, "I'm a part of this homeownership project." How does that all work under the hood? Domingo Valadez (04:07):I'll share the Homebase side, then I'll share the user experience side. So it's actually quite complex to make it work. It took us seven months to build out the legal frameworks to how to do this and then building out the software for tokenization took about two months for us to do. But just to walk you through this first home, how we did it effectively, we found a property that was suitable. We put it under an exclusive buyer seller agreement, so Homebase had full rights to sell the house on behalf of the owner. We then spun up a special purpose vehicle that was sole intent was to purchase that property, and so then we created NFTs that represent ownership in that special purpose vehicle and we had a mint date on that mint date. It was basically like the day we started selling the property. (04:45):And so people could literally go to our website, these are people that have already KYC accredited, non-accredited, could then buy tokens with USDC and they would mint them directly on our platform. And so they would get those tokens immediately to their account and then in tandem they would get DocuSign documentation sent to them. So they have to sign a legal LLC operating agreement, they need to sign a security token purchase agreement, all this legal documentation that basically says like I am buying tokens using USDC and I'm now a member of this LLC that was created. So once we acquired all the money that was necessary, we then closed up the SPV and then actually completed the transaction. And so the owner received the amount of money that they were trying to sell on his first property, and then once that was closed, we then filed with the local title companies to basically transition the title from the owner into this new SPV we created. (05:40):So the piece that's truly on chain are the NFTs we created to represent ownership, but we're pretty much a Web 2.5 company where we do need to know who exactly owns what tokens, and we only whitelisted wallets can effectively trade them between themselves. So we file these as Reg D 506, security, private placement offerings, and in that regulation you have to hold the investment for at least a year. You can't trade it for that initial year, and then after that you can sell it through our platform either back to us or eventually want to allow for peer-to-peer trading, but we need an alternative trading system license for that, which we don't have yet. So the majority of it's going to be people selling it back to us and then us reselling it to the next person. Brian Friel (06:23):That makes a lot of sense. That was going to be one of my follow-up questions because given the permissionless nature of most tokens by default on chains, I was wondering how that works within a legal framework. You mentioned this first home that you guys tokenized from what I saw, it sold out within the first two weeks. It was a great success, but you guys basically just proved a use case that, "Hey, within the legal framework of how this exists today, this actually works." I think we could get into in this podcast talking a lot about where you guys see this going in the future and how this whole process is going to evolve. But can you talk a little bit about even just this first home that you guys tokenized and sold, what were some of the immediate benefits that you saw using Solana or blockchains in particular that might be different than the normal process? Domingo Valadez (07:09):I think a lot of the benefits are for users, not for us as the company doing it. So there was still a lot of complexity when it came to structuring all this and every single home we tokenize and sell on the platform has a lot of complexity behind the scenes, but for the end user, people could literally invest in this first home within five minutes. That's how long it took some of our users to purchase these tokens. And then they're just relying on us to do all the paperwork on the backend. Moving forward, we're going to be distributing out all funds using USDC, we're actually partnering with Circle. They're our money transmitter. They're the ones basically sending out all the funds to every single holder and we're going to be doing that monthly. (07:46):So as an end user, you just became a fractional owner in this property. You don't need to deal with any sort of property management headaches. You get your passive income and when you're ready to sell, you can just sell it back to us. We're going to be partnering with blockchain home registry to showcase the value of the properties monthly, and so you'll be able to sell it at true fair market value as dictated by five different data points of trusted institutions saying, "This is what the value of that property should be." Brian Friel (08:11):That's pretty awesome. One thing I want to hit on too is you mentioned that there's accredited investor checks, but is this also open to non-accredited investors as well? Domingo Valadez (08:19):We can have up to 35 non-accredited investors participate per home offering. It's limited to that just by the Reg D 506 B offering that we do, but we can have unlimited accredited. So moving forward, we think the 35 non-accredited spots will be taken pretty quickly because of course that's the main use case for people where they see the main value in what we're doing. But yeah, we plan to switch to Reg A offerings in the future and that'll allow anyone to participate. No limitations whether accredited or non-accredited. Brian Friel (08:47):These terms, accredited investor, unaccredited, Reg A, they're very, I would say US-centric. There's a lot of particular nuances to US investing laws that maybe contribute to why folks like us are interested in these kind of products. We can't always afford residential real estate in areas that we live and work. Is Homebase exclusively focused on the US Do you guys also see this problem internationally and can you talk a little bit about maybe how the US differs from some other major markets internationally? Domingo Valadez (09:17):The US probably has the toughest regulation when it comes to this. So for us, we very much wanted to tackle one of the hardest markets and also two of the three co-founders are US based, are three co-founders in Canada and both markets so similar, very, very expensive real estate in any sort of big city all feel priced out. So we really all align in the mission behind this. Our initial launch market was in McAllen, Texas, so that's where I'm originally from. So it was very near and dear to my heart to launch there and see properties that I grew up with actually get access to the internet and get tokenized in that capacity. But we'll stay likely in the US for the near medium term, but we do want to allow international investors to participate as well. So we've already been reached out to by a few big players internationally that want to be LPs in our future properties and then they can sell it to some of their customers as well, and that's how we'll open it up and expand the pie to international investors as well. Brian Friel (10:12):I love that. So you mentioned when you did the high level overview of how this process works, essentially onboarding people one by one, taking video calls with them, making sure they understand the process, having to give them tokens that there's restrictions on how they can actually be sent to different people if they want to resell. It oftentimes having to go through you guys that whole process and then I'm sure even just the whole process of you setting up these legal entities as Homebase and your Web 2.5 company right now, there's a lot of legwork that you guys are doing on the back end, abstracting this out. (10:45):I think listeners of this could imagine a world where one day this is all pushed more to the edges, to the actual token holders and owners themselves. How do you guys think about how this is going to evolve over time? Which pieces of this do you think potentially in the next couple years could be more evolve, looking in areas where you guys maybe at Homebase aren't doing as much legwork and which areas do you think are going to be a little bit slower to evolve over time? Domingo Valadez (11:12):US real estate's very locally driven. Not only do you have to follow federal regulation, you also have to follow state regulation. You also have to follow local regulation all the way down to the county level. And so understanding each of those three layers of regulation is really important. And so that drove a lot of where we first launched. So Texas is very pro landlord, they're pro tendency in common, so it was very easy to fractionize the property there and they don't have any sort of transfer taxes. So if I sold my tokens to you, other states or other cities would charge a tax on that, Texas doesn't. So that was a big piece that kind of decided where we even launched on the piece about where we're going and what do I think is going to get better over time. One of the big reasons we even did this on chains, we've had a lot of people say, "Why don't you just fractionize this without blockchain that's so complex, you're making your process harder." (12:00):It's really about the secondary financial implications of what it means to have things decentralized and on an open platform. So for example, we're already in discussions with an on chain lender to allow people to collateralize their tokens to actually take on chain debt. No bank, no credit score required, literally just you collateralizing your tokens to take on debt and that to me is a beautiful thing. You cannot own any piece of a home without a mortgage under your name or a bank, someone getting involved and checking out your credit score. So that to me is really, really exciting and something we can already do with the first home moving forward. Another piece would be as regulation gets looser, having more clarity around allowing peer-to-peer trading. So alternative training license is what we're going to be going for relatively soon, and that's going to allow for people to trade within themselves so they don't have to sell it back to Homebase, but actually allow for peer-to-peer trading. (12:55):To me, it's really just like all of the applications that then could get built on top of having real estate completely tokenized on chain is what gets me excited about the Web3 space. I think the pieces on the regulation that's going to push back is making sure everyone's KYC, making sure you know who your users are, making sure they didn't launder any of their money. But yeah, I think that's one of the biggest benefits of Web3 and creating liquidity in a market that's historically been pretty illiquid and at a very, very high prices. Brian Friel (13:23):Yeah, I think you're right. There's this element of composability that comes with this when this is native to the internet, it's online and there's a token, anyone can [inaudible 00:13:34]. Then like you said, build a lending market around that. And there's a world where one day you guys aren't even involved with that decision, it's just someone can just sole end or another project can say, "Hey, we already have this lending market and we accept these tokens now as collateral." My gut tells me that you guys are doing this by the book. That regulation is going to be the rate limiting step in all of this as it starts to go. How do you guys see the current regulatory landscape in the US and you mentioned that there's some differences not just federally, but on state levels and on county levels. Can you talk a little bit about that and why maybe you guys are choosing to start in Texas and where you guys, I mean maybe foresee the next markets that you guys are expanding to as well? Domingo Valadez (14:18):You're absolutely right. Regulation's going to be the inhibitor on doing a lot of Web3 related transactions for properties. I think Coinbase getting sued by the FCC is going to provide a ton of clarity around... Or that's my hope at least a lot of clarity around how Web3 companies should be operating. I think there's been a lot of confusion around what's legal, what's not legal. So just to keep our users safe, we chose the web2 legal approach where we tried being as closely to the book as we can in case things go wrong or awry. Our users are completely fine and we feel very confident with that. But of course as we continue scaling the company and getting bigger, we love for these secondary applications like a Solend. To just say, "Hey, we just created this lending platform, we actually don't need your permission to do it. We can just trade." (15:05):That to me would be amazing because that means we're succeeding in actually bringing homes on chain and tokenizing them and letting people do what they want with their assets. But the regulation's really going to kick in until then. Texas was great because it was very landlord friendly, very easy to fractionize the property and no taxes associated with that. We'll likely continue to stay in Texas for the near to medium term, we're in McAllen now, plan to go to Austin later this year. (15:31):Other markets we'd likely open it in would be Colorado is also pretty open to this. So is Florida, specifically Miami is pretty pro Web3 and pro tokenization. It would be very, very city state dependent on what laws they have in place and how we can make this work. For example, even us opening it up to international investors, that requires us to redo some of the legal structures we have to allow for international investors to even invest. So we're going to very much rely on partners that say... There's a lot of demand in Latin America, for example, specifically from this country, "Okay, that's going to be the first country we allow to invest internationally just because of the regulatory piece of that." And we don't want any of our users to worry about that. So we're trying to remove all that complexity for end users while Homebase deals are all the complexities around that. Brian Friel (16:19):That makes a lot of sense. Miami, Florida doesn't sound like the worst place to be a homeowner as well, so that aligns pretty nicely. Taking a step back as an end user who's thinking about this, let's say that somebody has a Phantom wallet, they've experimented with sending some crypto to their friends, they maybe have a few NFTs. What would they need to know to feel confident in taking this next step and being an owner of residential real estate? Is it as simple as just showing up to your guys' website, hitting connect wallet, filling out a couple forms in a Zoom call? Is there anything that they need to do after they've already completed the purchase or other things that they should be aware of? Essentially, could you walk us through the user journey from getting their first wallet to actually being a homeowner? Domingo Valadez (17:05):Yeah, absolutely. So funny enough, for our very first property, we actually had a lot of new to Web3 users participate. So plug for you guys, we had Phantom as the preferred wallet for people to create and effectively onboard into the Solana ecosystem. And I think something that was very beautiful about this was people could upload their money into Coinbase, send Solana or USDC and Solana to their Phantom wallet and see it happen in two seconds within the call that we were helping them do it. So I don't think it's the same thing for other chains, but that's something that Solana does really, really well. So once you have a loaded wallet, you as you mentioned, have to make an account on our website, you do need a KYC, you set up a quick call with us, just it's your way of understanding who we are as founders and you can ask us questions directly. (17:50):It's really just to build trust with people. But once we have a home that's live, you literally just go to the property page, you connect your wallet that we've already whitelisted preemptively, and then you can just buy however many tokens you like. So every single token is denominated in a hundred dollars, so everything's transacted in USDC and you can just buy however many tokens you like, they immediately get minted to your wallet and then you get sent DocuSign links to sign that'll make you truly a fractional owner of the legal entity we spun up to acquire that property. So once you purchase it and everything closes, you don't need to worry about anything. We know exactly whose wallets hold what tokens, and we just start sending you your proportional amount of net rent every month and then you can decide to sell whenever you'd like. Brian Friel (18:35):So there's no upkeep. Part of the joys of being a landlord is things break in houses, there's taxes, property taxes to pay, all this kind of stuff. All of that is abstracted away from an end user. Domingo Valadez (18:47):So any home we list on our platform, we charge an extra 5% fee and that's really just to have a capital reserve pool. So if anything breaks, like we as Homebase have a property manager, they'll go out and fix it and then we refill that reserve pool with rent. So the goal is to never ask people that purchased it for money, we can refill it ourselves with the rent we collect, which is what's beautiful about real estate, it's cash generating and in terms of property taxes, we handle everything from that end. We do distribute K1s to everyone at the end of the year because everyone has their own personal income taxes they need to pay. So we can't force you to pay them, but we can give you all the information you need to pay them on your behalf. Brian Friel (19:25):That makes a lot of sense. I was also thinking when we talked earlier about the layers of this that could be abstracted away and evolved over time, that's potentially one of them, but I'm not sure if people actually at the end of the day want that. Is there a world where there's Homebase down people are voting on how do we pay for fixing the plumbing leak? I have a feeling that that's a service that all owners here are pretty glad that you guys are handling on behalf of them. Domingo Valadez (19:50):Yeah, one thing that is true though is people can vote us out. So we're the default manager of the property, but if you're not happy with the job we're doing, you can absolutely vote us out. Brian Friel (19:58):Oh, that's interesting. How does that vote happen? Is that an on chain vote with tokens or how did you guys set that up? Domingo Valadez (20:05):Yeah, so not on chain right now, but theoretically you're truly an owner of the LLC and you have voting rights in that LLC. So if people just came together and said like, "Hey, we want to vote them out." There's a meeting set up, people say like, "Yay, we want to remove Homebase." We won't be the manager anymore. It'll be up to the owners to pick a new manager and then that's how they can start facilitating the management of that property. Brian Friel (20:28):Wow, that's fascinating. Domingo Valadez (20:30):Yeah, we truly want people to be owners. Brian Friel (20:32):Oh, that's really cool. So I guess I have a couple questions here to kind of wrap up, but you mentioned that you guys are onboarding a lot of net new users to Web3, essentially people getting their wallet for the first time, maybe they don't fully understand how to use these wallets or the gravity of sending things on chain and the irreversibility of a lot of this. Do you guys have any particular insights from getting on calls with these people and walking them through this process? Do these users stay in crypto in your view? Do they stay engaged with it? Is it a steep learning curve for them? Basically, how as an industry are we doing at onboarding these people who maybe find crypto not because of crypto but because of a use case Homebase where they're just, it's a solution to their problem. Domingo Valadez (21:15):So very transparently, I'd say some people do have difficulty and it's a 30-minute call, and other people it's very easy. So I think something a lot of users asked for was like, "How can we abstract the complexities of wallets even further?" We're thinking about potentially having noncustodial wallets on our website where we partner with someone that basically just showcases the wallets directly there and then for an end user, it doesn't matter if it's crypto, you just know you own tokens in a property, you didn't have to create any wallet, it was automatically created for you. But for the people that do know Web3 and have their own Phantom wallets, have their own personal wallet, they can do what they like with those tokens and use on chain, that sort of piece. So I think for the industry to continue to expand, we need to continue to make it easier for people to onboard, abstracting away a lot of the complexity is something that'll continue to be key to keep widening the pie for everyone. Brian Friel (22:09):Totally. I can't imagine the call where someone buys a bunch of shares in a residential property and then forgets their seed phrase so, these are things that we're thinking about as well. I mean, I liked that framing of essentially giving users the easy option to start and the optionality to eject from that and really take control if you really know what you're doing. I think that's awesome. Domingo Valadez (22:31):Absolutely. Brian Friel (22:32):Well, this has been an awesome discussion, Domingo. Before we wrap up with one closing question, I always ask everyone I want to know for you too, what excites you the most right now from where you guys sit in this new field of on chain residential real estate, where are you guys heading next and what do you think is the most exciting next frontier? Is it new markets? Is it improvements in the way this is happening on chain? Is it in regulation? Or maybe it's something completely different that you guys are seeing? Domingo Valadez (22:57):I'd say one of the biggest drivers for me for building Homebase, we want to redefine home ownership and what that even means, I think we'll continue to see real estate prices keep getting more and more unaffordable for folks. And I think being a homeowner's going to start being a privilege, which is a really sad reality. Unless we have true government intervention come in and add more housing supply, I think it's going to get worse. And so with that reality, it's like it's up to private markets to figure out how do we actually make more people homeowners? So something we care a lot about at Homebase and something we're very mission driven about is making the tenants that live in these properties, also fractional owners of them. And so getting people comfortable with the idea of only owning 10, 20, 30% of their property, but still feeling like an owner of that property. (23:42):And so for this very first home, for example, Homebase bought an extra piece of it so that we can offer it to the tenant to actually buy it from us so that they can also be a fractional owner of the apartment they're living in. And so in 10 years we want Homebase to be the destination for renters. When you're moving to a new city, you use a Homebase platform, you find an apartment, you move in, you buy 30% of the value, and now you're a fractional owner of that property. So that's why Web3 excites me. You can completely do this in an open liquid market and we're trying to facilitate that through Homebase. Brian Friel (24:14):Yeah, that's putting skin in the game too, right there, you're a renter and you actually have upside if you treat the place well. That's pretty cool, and I think that's kind of spinning the model on its head in a really crypto native and interesting way. And I love that framing. Well, Domingo, this has been an awesome discussion. One question we ask all of our guests, and I want to know this for you as well, is who is a builder that you admire in the [inaudible 00:24:38]. Ecosystem? Domingo Valadez (24:38):Okay, this is going to be a total cop out, so I'll give you two. My first one's [inaudible 00:24:44]. I love that man's Twitter content. I feel like the way he speaks, he's clearly very, very technical, but also very good at bringing things to a high level and explaining things. And it's no secret that Solano ecosystems gotten a lot of heat from a lot of third parties where the day FTX went down, someone from the Binance blockchain basically told me I was dumb to continue building on Solana and was really trying to pull us to build on their chain. (25:09):And I was like, "I think the leaders of Solana are taking this very well and are being very, very thoughtful about how they're moving things forward." So that's the first piece really, really like [inaudible 00:25:19]. The second one's [inaudible 00:25:21]. I love his content. He's been a champion for Solana and you can always rely on that guy to call out people that are spewing fake news about the chain and really showcase his technical know-how of how things truly work behind the scenes. So I think those are probably my two biggest, I fanboy over both of them a good amount. Brian Friel (25:43):I think those are both great choices. And a sneak peak, you mentioned that the [inaudible 00:25:47]. Recording was just before this, but [inaudible 00:25:49]. Also mentioned [inaudible 00:25:50]. As his choice. So you're in good company there. Part of what [inaudible 00:25:55]. Was saying too is he loves people that are building pragmatic applications that can "Only be done on Solana TM." And I think Homebase is a really awesome shiny example of that. So thank you so much for taking the time to walk us through it. I'm super excited. I'm going to have to check it out, bring my Panama to it. I know nothing about residential real estate, but I think you've given me the confidence to give it a try today. For folks who want to check it out, where can they go to learn more about Homebase? Domingo Valadez (26:22):Yeah, you can go directly to our website, which is Homebasedao.io. Brian Friel (26:26):I love it. Domingo Valadez (26:27):Everything's completely transparent on our website, we even have a white paper that goes into all the technical pieces, whether it's the legal side, whether it's all the technical side on the blockchain component piece. So we're very, very transparent and we also have a discord where we answer questions as people have them. Brian Friel (26:42):That sounds great. Domingo the co-founder of Homebase, thank you so much for coming on. Domingo Valadez (26:48):Absolutely. Thanks so much, Brian, for having me.   

When Walmart went public in 1970 and soon thereafter listed on the New York Stock Exchange, its SEC disclosure prospectus was 20 pages long.  Today, a prospectus requires massive numbers of mostly obscure disclosures imposing very real liabilities for the issuing company - but which no one reads, except for lawyers who charge $2,000 an hour to read it and to write it - and which can run upwards to 300 pages or more.  Under President Joe Biden's whole of government effort to weaponize federal agencies, this regulatory creep has become an outright onslaught of new regulations. Except now it brings an overt political agenda to promote ESG and “equity” outcomes. Case in point is the SEC under Chairman Gary Gensler (who was Hillary Clinton Campaign's CFO), which has proposed 55 new rules and massive climate change disclosure requirements without any mandate from Congress. “Over the last two years, we've seen more rules than we've ever seen before,” explains my guest on this episode Chris Iacovella, “the amount of paper, the amount of costs that are being heaped on companies, not just in the financial services space, but in every sector of our economy, are far outweighing whatever good they are supposed to be doing.” Chris Iacovella is in a position to know. He is the President and Chief Executive Officer of the American Securities Association, and has deep expertise in the equity, fixed income, and derivatives markets, as well as growth capital and wealth management. Prior to becoming CEO of the ASA, he was the CEO of the Equity Dealers of America and Director of Global Government Affairs at Bloomberg LP.  “Gensler claims that he has to do this because investors are clamoring for this disclosure, but it's not investors that are clamoring for it. It's Wall Street asset managers, investment banks, and institutional investors who are pushing an ESG political agenda into the boardroom that they can't get through Congress.” This is just one of the many concerning issues we get into in this episode. Some others: The higher fees Wall Street charges for its ESG funds. Klaus Schwab (of the World Economic Forum) and his “stakeholder” capitalism and how Wall Street has adopted many of his views.  Public company security regulations seeping into private businesses. A long segment about how the Chinese have used the US capital markets to access to American capital and allowing them to fund their military and economic rise with our money. Something obscurely called the Consolidated Audit Trail where the SEC has decided to add to its surveillance capabilities, the ability to collect all of the personal and financial information of every investor who has a share of stock in our capital markets.  “Can you imagine if the SEC entered into a memorandum of understanding with the IRS? Then the government would have a true and complete picture of not only your securities holdings, but also any businesses that you might own that are private, any real estate that you may own. It's would be complete picture of what your wealth is.” There's a lot to unpack in this episode, but I think you'll find it worth your time.

On this episode, were doing a full breakdown into the U.S. Hearing Entitled: “The Future of Digital Assets: Identifying the Regulatory Gaps in Digital Asset Market Structure”. Filecoin testified for crypto use cases outside of finance and anti-crypto advocate Hillary Allen was brought on to spew her typical crypto hatred.

Review of the Federal Reserve's Supervision and Regulation of Silicon Valley Bank Silicon Valley Bank (SVB) failed because of a textbook case of mismanagement by the bank. Its senior leadership failed to manage basic interest rate and liquidity risk. Its board of directors failed to oversee senior leadership and hold them accountable. And Federal Reserve supervisors failed to take forceful enough action, as detailed in the report. Our banking system is sound and resilient, with strong capital and liquidity. And in some respects, SVB was an outlier because of the extent of its highly concentrated business model, interest rate risk, and high level of reliance on uninsured deposits; however, SVB's failure demonstrates that there are weaknesses in regulation and supervision that must be addressed. Regulatory standards for SVB were too low, the supervision of SVB did not work with sufficient force and urgency, and contagion from the firm's failure posed systemic consequences not contemplated by the Federal Reserve's tailoring framework. Following SVB's failure, we must strengthen the Federal Reserve's supervision and regulation based on what we have learned. This report represents the first step in that process—a self-assessment that takes an unflinching look at the conditions that led to the bank's failure, including the role of Federal Reserve supervision and regulation.Individuals who were not involved in the supervision of SVB conducted the review, and I oversaw it. The four key takeaways of the report are:1. Silicon Valley Bank's board of directors and management failed to manage their risks.2. Supervisors did not fully appreciate the extent of the vulnerabilities as Silicon Valley Bank grew in size and complexity.3. When supervisors did identify vulnerabilities, they did not take sufficient steps to ensure that Silicon Valley Bank fixed those problems quickly enough.4. The Board's tailoring approach in response to the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA) and a shift in the stance of supervisory policy impeded effective supervision by reducing standards, increasing complexity, and promoting a less assertive supervisory approach.

Elon Musk discussed the debut launch of the Starship rocket, stating it exceeded expectations with minimal launch site damage. He anticipates another flight in 2-3 months, and with upgrades to the rocket and launch pad, he expects the next Starship launch attempt in 6-8 weeks. Regulatory hurdles may take longer, but Musk hopes for up to 5 flights this year and estimates SpaceX will spend $2 billion on the Starship program in 2023. The post Elon Musk Reflects on Starship Debut, Anticipates Next Flight in Months #1666 appeared first on Geek News Central.

This week, Noah Kaufman (Center on Global Energy Policy at Columbia University) joins Joseph Majkut (Energy Security and Climate Change Program at CSIS) to discuss the recent Executive Order on modernizing the regulatory review process, and its implications and benefits for the U.S. climate regulations.    Executive Order on Modernizing Regulatory Review Preamble: Proposed OMB Circular No. A-4, “Regulatory Analysis”

Welcome to another edition of the InsuranceAUM.com podcast. I am Stewart Foley, I'll be your host. Everybody's been asking us to have a regulator on, and we finally have one. Today I'm thrilled to be bringing you a very good topic, and a great panel on our podcast. The topic of conversation is ‘trends in US insurers' ownership structure, in the evolving regulatory landscape.'

Today's episode is sponsored by Origin Dollar: With U.S. inflation still at 5% and multiple CeFi lending platforms bankrupt, DeFi protocols that earn interest on stablecoins are again back on crypto investors' minds. See here for more details: http://realvision.com/origindollar What does the second-largest bank failure in U.S. history mean for crypto and regulation? Brett Quick, head of government affairs for the Crypto Council for Innovation, joins Ash Bennington to discuss the collapse of First Republic Bank, what it means for crypto investors, and why the regulator's aggressive actions might be a silver lining for the industry. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Food is a necessity for life. It should therefore surprise few that the federal government regulates the production and processing of food before it reaches our dinner tables. Labels indicating some meats are “USDA-Prime” or confirming that the product was inspected and approved as safe before delivery to the grocery store reflect this regulatory role.While labels may make the regulation apparent, which part of the administrative state handles that regulation can be less clear. Two agencies: the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) -- part of the Department of Health and Human Services -- both have jurisdiction over the foods we consume. Which agency handles what is not always apparent. Recent illnesses and deaths involving baby formula and spinach -- both under the FDA's inspection jurisdiction -- have emphasized that regulatory structure can have life-or-death consequences. This has led some on both sides of the aisle to suggest a revamp of how we handle food safety regulation. One group contends the FDA should take the lead (Food being literally in the name); a second argues the USDA should run point (agriculture being the first step to food production), and a third group argues creating a separate agency entirely would be the best solution. The FDA itself has proposed an internal reorganization to emphasize its food safety mandate.This panel of FDA and USDA veterans whose service spanned multiple administrations will examine the questions (1) how safe is our food, (2) is a reorganization of the agencies that handle food safety necessary to achieve the maximum level of safety, and (3) how should such a reorganization look.Featuring:Dr. Mindy Brashears, Associate Vice President of Research, Endowed Chair, Professor & Director, International Center for Food Industry Excellence, Texas Tech University; Former Under Secretary of Agriculture for Food Safety, United States Department of AgricultureDr. Stephen Ostroff, Former Acting Commissioner and Former Deputy Commissioner for Foods and Veterinary Medicine, United States Food and Drug AdministrationFrank Yiannas, Former Deputy Commissioner for Food Policy and Response, United States Food and Drug Administration[Moderator] Hon. Stephen Alexander Vaden, Judge, United States Court of International Trade; Former General Counsel of the United States Department of AgricultureVisit our website - www.RegProject.org - to learn more, view all of our content, and connect with us on social media.

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Hospital utilization and billing are notoriously challenging concepts for providers and case management staff because they frequently boil down to two, often conflicting points of view: what can be done per the rules, regulations, and contracts, and what should be done to provide the most effective care for a patient?  In a world where process standardization is imperative to maintain health system viability, but also where the practice of medicine remains an art, teams need a broad understanding of medical necessity and billing rules.Join us during the next live edition of Monitor Mondays when Dr. Juliet B. Ugarte Hopkins reports on where you can give and take and how to parse out the varying shades of grey.Broadcast segments will also include these instantly recognizable features:Monday Rounds: Ronald Hirsch, vice president of R1 RCM, will be making his Monday Rounds.The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullen, will report the latest news about auditors.Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Bryon, will join the broadcast with his trademark segment.Legislative Update: Matthew Albright, chief legislative affairs analyst for Zelis, will report on current healthcare legislation.& so much moreA bi-monthly podcast where we share the stories of our Caregivers, patients and...Listen on: Apple Podcasts Spotify

The rapid evolution of technology has ushered in the API revolution in cybersecurity, transforming the way organizations navigate an AI-driven threat and security landscape. As CTOs and CISOs grapple with the delicate balancing act of managing risk and innovation, they must adapt to the demands of securing a modernized world. This postmodern paradigm shift in cybersecurity necessitates a comprehensive understanding of emerging trends and cutting-edge solutions to effectively safeguard our increasingly interconnected digital ecosystem.Dive into this captivating podcast episode featuring Kunal Anand, the CTO and CISO of Imperva, as he discusses the evolving world of cybersecurity and the impact of emerging technologies such as artificial intelligence. Alongside host Sean Martin, Kunal shares his experiences as both a CTO and CISO, highlighting the importance of peer-to-peer collaboration and the integration of modern technologies in the cybersecurity landscape.Kunal and Sean delve into the significance of APIs in modern applications and the challenges of securing them in the face of ever-increasing data breaches. They also explore the transformative power of AI in both offensive and defensive security, including its role in enhancing productivity and effectiveness in cybersecurity efforts crossing all cybersecurity roles from analyst to executive.Kunal also shares his insights into the future of cybersecurity and the need for the industry to embrace AI and other emerging technologies. This discussion offers valuable perspectives for anyone interested in understanding the evolving challenges and opportunities in the cybersecurity world. Don't miss this chance to learn from someone who thinks differently, thinks creatively, and thinks broadly about the challenges we face and the paths we can take to overcome them.Note: This story contains promotional content. Learn more: https://www.itspmagazine.com/their-infosec-storyGuest:Kunal Anand, CTO and CISO at Imperva [@Imperva]On Linkedin | https://www.linkedin.com/in/kunalanand/On Twitter | https://twitter.com/kaResourcesLearn more about Imperva and their offering: https://itspm.ag/imperva277117988For more RSAC Conference Coverage podcast and video episodes visit: https://www.itspmagazine.com/rsa-conference-usa-2023-rsac-san-francisco-usa-cybersecurity-event-coverageAre you interested in telling your story?https://www.itspmagazine.com/telling-your-story

In this Their Story podcast episode, Pam Murphy, CEO of Imperva, talks to Sean Martin about the challenges facing businesses in terms of cybersecurity.Murphy explains that data is the most valuable asset of any company and that protecting data is a vital aspect of cybersecurity. Murphy discusses the growing importance of APIs in the current environment, and how securing APIs is a challenge for CISOs, with many Shadow APIs being used. Murphy also notes that the regulatory aspect of security is increasing, with more rules and regulations emerging around the world.Businesses face reputational risk and can suffer major operational disruption as a result of a breach, making security more important than ever. Murphy explains how Imperva helps customers protect their data, applications, and APIs from cyberattacks, and  discusses the need for security vendors as trusted partners to focus on time to value and total cost of ownership, especially given the growing skills shortage in the security sector.Note: This story contains promotional content. Learn more: https://www.itspmagazine.com/their-infosec-storyGuest:Pam Murphy, CEO at Imperva [@Imperva]On Linkedin | https://www.linkedin.com/in/pam-murphy-a5297915/On Twitter | https://twitter.com/PamMurphyInTechResourcesLearn more about Imperva and their offering: https://itspm.ag/imperva277117988For more RSAC Conference Coverage podcast and video episodes visit: https://www.itspmagazine.com/rsa-conference-usa-2023-rsac-san-francisco-usa-cybersecurity-event-coverageAre you interested in telling your story?https://www.itspmagazine.com/telling-your-story

On this edition of the Weekly Recap, NLW breaks down: Gary Gensler's latest cringey SEC video Coinbase's Wells Notice response  Dual legislative hearings from Thursday  Enjoying this content? SUBSCRIBE to the Podcast: https://pod.link/1438693620 Watch on YouTube: https://www.youtube.com/nathanielwhittemorecrypto Subscribeto the newsletter: https://breakdown.beehiiv.com/ Join the discussion: https://discord.gg/VrKRrfKCz8 Follow on Twitter: NLW: https://twitter.com/nlw Breakdown: https://twitter.com/BreakdownNLW “The Breakdown” is written, produced and hosted by Nathaniel Whittemore aka NLW. Research is by Scott Hill. Editing is by Rob Mitchell and Kyle Barbour-Hoffman. Our theme music is “Countdown” by Neon Beach.

One of the most common misconceptions about the opioid crisis is that it only affects people with a long history of drug abuse. Today, more than ever, a more diverse population is affected, potentially due to illicit fentanyl on the black market. In this ACT ToxChats© podcast, joined by Dr. Richard C. Dart of the Rocky Mountain Poison and Drug Safety, Denver Health and Hospital Authority, we discuss the history of opioid abuse, the factors that might have contributed to the current crisis, and other drugs that have played a role. We also discuss ways pharmaceutical and regulatory toxicologists may intervene.

Usman Ahmad is the CEO of Zodia Markets, a crypto trading firm that partners with institutions and corporations. Zodia Markets is already registered by the UK's Financial Conduct Authority and is in late stage conversations with the central bank of Ireland, which with new EU regulation means a passport to Europe. But given demand from the U.S., the firm has accelerated its strategy. In this episode, Ahmad talks about Zodia, its evolution and the division of custody. During this episode, Chaparro, and Ahmad also discuss: Zodia's risk management strategy How to develop a diverse crypto business Potential catalysts in the months ahead This episode is brought to you by our sponsors Circle and CleanSpark. About Circle Circle is a global financial technology company helping money move at internet speed. Our mission is to raise global economic prosperity through the frictionless exchange of value. Visit circle.com/Scoop to learn more. About CleanSpark CleanSpark (NASDAQ: CLSK) is America's Bitcoin Miner™. Visit cleanspark.com/theblock to learn more about the CleanSpark way.

This week on the show, I'm bringing you yet another treasure from the vault – my Season 1 conversation with Drew Slack, where we talked about his journey from his PhD in pharmacology to his current career in the medical regulatory space. This is a special episode for me, because of the energy of this... The post The Regulatory Domain as a Path for PhDs With Drew Slack appeared first on Papa Phd Podcast.

Sally Powell Price is MilliporeSigma's Regulatory and Public Health Expert for Food and Beverage Safety Testing in North America. Previously, she served as Director of Lab Operations at a biotech startup in Boston and was the Food Lab Supervisor at the New York City Department of Health Public Health Laboratory. She holds a B.S. in Biology from Hamilton College, a M.S. in Microbiology and Immunology from James Cook University in Australia, and did continuing coursework in public health and foodborne disease at Harvard TH Chan School of Public Health. She is a member of the Association of Food and Drug Officials (AFDO), the Association of Public Health Laboratories (APHL), the International Association for Food Protection (IAFP) and AOAC International.  Justyce Jedlicka serves as the Food and Beverage Regulatory Liaison in North America for MilliporeSigma. Responsible for engaging with influencers in the food and beverage industry to align initiatives with regulatory compliance and promote best practices for food safety and quality testing methods, Justyce has been serving the food and beverage industry since 2013. She received a B.S. in Chemistry and an M.B.A. from the University of Missouri in St. Louis. She currently serves as the Food Sciences Section Chair and Executive Board Member of the American Council of Independent Labs and is a member of IAFP, International Society of Beverage Technologists (ISBT), and AOAC International. In this episode of Food Safety Matters, we speak with Sally and Justyce [3:00] about The impact of food safety failures in baby formula production in recent years The risk factors for contamination in infant and baby foods and why contamination has been more of an issue at late The regulatory changes being made in response to recent foodborne illness outbreaks linked to formula How protecting infant health influences sustainability and corporate responsibility initiatives How customers can leverage companies like MilliporeSigma to take the right steps towards safety and compliance Recommended resources and trade organizations for those interested in understanding the issue of infant formula safety in greater depth. Resources: "Ask the Expert: How to Choose the Right Method for Microbial Testing in Infant Formula?" Support for Food and Beverage Testing Heroes  Sponsored by:MilliporeSigma We Want to Hear from You!Please send us your questions and suggestions to podcast@food-safety.com

Join Brian and guest Scott Dunn as they share practical tips on navigating the challenges and achieving success in implementing Agile practices in regulatory environments on this episode of the "Agile Mentors" podcast. Overview: In this episode of the Agile Mentors podcast, Brian and Scott Dunn delve into the challenges of implementing Agile practices in regulatory environments. They discuss the importance of finding ways to work within regulatory frameworks, building trust with stakeholders, and adapting Agile principles to fit the unique needs of the organization. Listen in to discover practical strategies for navigating regulatory hurdles, effective communication with regulators and customers, and building a culture of continuous improvement in highly regulated industries. Listen Now to Discover: [01:30] - Brian welcomes Scott Dunn to the Agile Mentors podcast. Scott is a Certified Enterprise Coach and Scrum Trainer with over 20 years of experience. Today's show is focused on the listener-inspired topic of implementing Agile in regulatory environments. (If you want to hear something specific, you can email us at podcast@mountaingoatsoftware.com). [02:31] - Change is hard. Sometimes you must dig deeper into the reasons for resistance, as it may not always be related to regulatory requirements. [03:09] - Scott shares his experience working in a compliance-heavy environment, noting that the people responsible for compliance may not always fully understand the regulations. [04:16] - Scott emphasizes the importance of researching the regulations independently. In his experience, mindset and willingness are key factors in successfully implementing Agile in regulatory environments. [06:05] - Brian shares an anecdote about a pushback he received in a private class about whether Agile principles would work in the real world. [07:59] - Scott shares a recent experience on a call with a Prime contractor for the government, where they discussed the government's modernization efforts and their shift towards agile methodologies. He also mentions the GSA's internal agile group, which requires funding recipients to adopt agile practices. [09:19] - The issue of government contracts requiring specific roles rather than generalists and how this can limit the implementation of agile practices. [10:20] - Scott discusses how contracts in government organizations can limit the ability to fully implement Agile principles and how to create change within their organizations. [11:33] - Brian discusses the idea that a transformation is an ongoing process and not something that can be checked off as completed. He talks about the importance of continual learning. [12:01] - Brian introduces the podcast sponsor, Mountain Good Software's Advanced Certified Product Owner course. He explains how the course can help product owners increase their confidence, credibility, and value. [12:39] - The importance of collaboration over contract negotiation: Brian shares a story about Michael Sahota, who worked with the Canadian government on a bidding contract and revolutionized the government's fixed bid system. [15:07] - Brian explains that while regulatory environments require more documentation, examining whether certain documentation is necessary is essential. [15:54] - The need for empathy and understanding when working with regulatory environments. [16:26] - Small nudges = Significant change. [19:45] - The challenge of testing in regulatory environments, particularly regarding validation. Brian shares a story about a client with FAA regulations and how they tackled the issue, emphasizing the importance of collaboration. [23:20] - Scott suggests a pragmatic approach to achieving work goals, acknowledging the external constraints that may prevent perfection. [24:09] - Scott further explains that in some cases, there may be a sliding scale of achieving different levels of agility. Even small incremental steps towards agile implementation can provide benefits. [25:37] - Brian shares what he considers the #1 win in implementing Agile into these types of environments. [26:57] - What's possible? If you fast forward a year from now, what could be done now that gets us to the next step? [28:10] - Think about how you are showing up: the importance of facilitating idea-generating conversations and the type of leadership it takes to start those conversations and helps make the right thing happen. [29:30] - Scott and Brian discuss the quote, "if you're the smartest person in the room, you're in the wrong room," and how important it is to be around people who can push you and help you grow. [30:52] - Join the Agile Mentors Community community to continue the discussion. If you have topics for future episodes, email us at podcast@mountaingoatsoftware.com. References and resources mentioned in the show: Mountain Goat Software's Advanced Certified Product Owner course Mountain Goat Software Certified Scrum and Agile Training Schedule Join the Agile Mentors Community Agile Manifesto​​ Scrum Alliance Subscribe to the Agile Mentors Podcast on Apple Podcasts Want to get involved? This show is designed for you, and we’d love your input. ● Enjoyed what you heard today? Please leave a rating and a review. It really helps, and we read every single one. ● Got an Agile subject you’d like us to discuss or a question that needs an answer? Share your thoughts with us at podcast@mountaingoatsoftware.com This episode’s presenters are: Brian Milner is SVP of coaching and training at Mountain Goat Software. He’s passionate about making a difference in people’s day-to-day work, influenced by his own experience of transitioning to Scrum and seeing improvements in work/life balance, honesty, respect, and the quality of work. Scott Dunn is a Certified Enterprise Coach and Scrum Trainer with over 20 years of experience coaching and training companies like NASA, EMC/Dell Technologies, Yahoo!, Technicolor, and eBay to transition to an agile approach using Scrum.

Whistleblower Report - Bombshell revelations at the recent Symposium of the UK's Medicines and Healthcare Products Regulatory Agency have revealed that the Agency is now a sovereign authority, no longer answerable to Parliament's oversight and largely controlled by Bill Gates and Microsoft with massive and dangerous changes...

In this episode of Medsider Radio, we sat down with Carol Burns, CEO of Cagent Vascular, a medical device company focused on developing and commercializing an innovative angioplasty balloon called the Serenator.Carol is a seasoned CEO and serial entrepreneur with a passion for cardiovascular devices. Her tireless energy and proven track record have enabled Carol to excel in all phases of medical device development, from early-stage proof of concept to eventual commercialization. Carol thrives in the fast-paced startup world, leveraging her industry relationships and clinical knowledge to identify technologies with the highest potential for success.In this interview, Carol highlights the importance of establishing the right team to lay the proper foundation for your medtech startup. We further discuss how to prioritize essential product features and their clinical applications for future growth, as well as overcoming fundraising challenges through effective networking. She also highlights the importance of listening to study investigators and designing strategic clinical trials to generate valuable data and drive success.Before we jump into the conversation, I wanted to mention a few things:If you're into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You'll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you're interested, go to medsider.com/subscribe to learn more.

On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda.  Niedre discusses: * Common Technical Document * Combination Products Structure for eCTD Submissions * EU vs. US Submission Expectations * Design Controls and Human Factors data placement * Regulatory Roles and Responsibilities in Pharma Niedre Heckman, PhD, MPH, FRAPS is the Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. She's a fellow of Regulatory Affairs Professionals Society (RAPS) (FRAPS), and holds an MPH and PhD in Public Health. Niedre has worked at Takeda, Baxter International Inc., Shire, Baxalta, 3M, and GSK. Niedre has a wide career in Regulatory Affairs, Quality, and Research with focuses in many modalities of medical devices, pharmaceuticals and combination products. Niedre couples her background in RA & QA with her expertise i