Podcasts about Regulatory affairs

In this insightful episode of the HVAC School podcast, host Bryan sits down with Jennifer Butsch, Director of Regulatory Affairs at Copeland, to discuss the rapidly evolving regulatory environment affecting the HVAC industry. With eight years of experience at Copeland and a background spanning codes, standards, and regulatory affairs, Jennifer provides a unique perspective on the challenges and opportunities facing contractors, technicians, and manufacturers in today's market. The conversation begins with an in-depth look at the EPA's Technology Transition Rule and the recent shift from R-410A to mildly flammable refrigerants like R-454B and R-32 as of January 1, 2025. Unlike previous refrigerant transitions that allowed for years of overlap, this transition was compressed into a much shorter timeframe due to building code requirements for the new mildly flammable refrigerants. While equipment delivery has gone relatively smoothly, the industry has faced significant challenges with refrigerant availability, particularly R-454B service gas. Jennifer discusses how OEMs have responded creatively, including pre-charging units with additional refrigerant and providing recovery cylinders as short-term solutions. The discussion also covers the ongoing debate about potentially returning to R-410A, which Jennifer argues wouldn't solve the current cost and availability challenges. She emphasizes that manufacturers have already invested heavily in transitioning their production lines and that rolling back would actually increase costs and timeline complications while moving in the wrong direction environmentally. The conversation touches on energy efficiency standards and the limitations of what can be changed under current legislation, noting that rolling back to pre-2023 efficiency levels would require Congressional action to revise the Energy Policy and Conservation Act. Jennifer and Bryan explore the complex world of tariffs and their impact on pricing stability, the potential defunding of Energy Star and what privatization might mean for the industry, and the challenges of regulatory fragmentation when federal oversight decreases and individual states create their own rules. The episode concludes with Jennifer's perspective on Copeland's philosophy of industry stewardship and practical advice for contractors on how to make their voices heard through trade associations and direct communication with legislators. Topics Covered: Technology Transition Rule - EPA refrigerant phase-down from R-410A to 454B and R-32 Refrigerant Availability Challenges - Current shortages in 454B service gas and industry solutions Mildly Flammable Refrigerants - Building code requirements and safety considerations R-410A Rollback Discussion - Why returning to previous refrigerants isn't a viable solution Energy Efficiency Standards - Legal limitations on rolling back efficiency requirements Tariff Impact - Effects on pricing stability and manufacturing decisions Energy Star Program - Potential defunding and privatization concerns Regulatory Fragmentation - Challenges when states create individual rules vs. federal standards Industry Stewardship - Copeland's approach to leadership and collaboration Contractor Advocacy - How to effectively engage with trade associations and legislators Manufacturing Investment Challenges - Impact of policy uncertainty on long-term planning Transition Timeline Management - Lessons learned and recommendations for future regulatory changes   Have a question that you want us to answer on the podcast? Submit your questions at https://www.speakpipe.com/hvacschool. Purchase your tickets or learn more about the 6th Annual HVACR Training Symposium at https://hvacrschool.com/symposium. Subscribe to our podcast on your iPhone or Android. Subscribe to our YouTube channel. Check out our handy calculators here or on the HVAC School Mobile App for Apple and Android

In the latest Almond Byte, highlights from June's Global Update by the Almond Board of California's Global Technical and Regulatory Affairs team include critical renewal steps for almond handlers exporting to China, detailed discussions with Chinese officials to strengthen trade relations, and insights from the ABC's 2025 Environmental Stewardship Tour showcasing sustainable farming practices. Additionally, significant updates on international tariff developments and their potential implications for almond trade were covered, emphasizing ongoing negotiations and legal proceedings affecting tariffs with China, the EU, Canada, and Mexico.

Nicholas Capman of The FDA Group welcomes David Marlin, Co-Founder and CEO of Metacomet Systems, to explore the often-overlooked complexities of royalty management in life sciences.Drawing from his experience helping over 200 companies automate royalty payouts, David explains how biotech, pharma, and medical device firms struggle to manage licensing agreements as they scale. What starts as a simple once-a-year payment can quickly evolve into a tangled web of tiered rates, stacked IP, country-specific rules, and audit requirements.David breaks down where companies most often go wrong—managing rules in Excel, underestimating the operational burden, and lacking traceability across contracts, SKUs, and sales data. He discusses how automation not only reduces risk and effort but also preserves trust with licensors by ensuring accuracy and transparency.The conversation also covers how organizations can recognize when it's time to move beyond spreadsheets, what a successful royalty system implementation looks like, and why experience matters in such a niche space.Whether you're paying or receiving royalties, this episode offers valuable insight into a critical but often misunderstood area of life sciences operations._____The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠https://www.thefdagroup.com/

What happens when AI goes viral — but the rules haven’t caught up? From Ghibli-style art generators to powerful large language models, generative AI is raising big questions around copyright, consent, energy use, and accountability. As businesses race to deploy these tools, who’s thinking about governance? IBM’s Stephen Braim, Vice President Governmental & Regulatory Affairs, Asia Pacific joins Lynlee Foo on Industry Insight to unpack the risks, regulations, and regional responses that could shape the future of AI governance in Asia and beyond.See omnystudio.com/listener for privacy information.

The dynamic duo Hancock & Kelley join the show for the first hour for some laughs and a discussion on the catty world of national politics. KMOX anchor Scott Jagow joins the show to share the funniest movie he's seen in a long time. St. Louis CITY SC broadcaster on Y98 Dale Schilly joins to discuss the team's win over San Jose and upcoming game vs Portland. Steve Wills, Senior Director of Regulatory Affairs with Ameren Missouri, calls in to explain why you might see an increase on your utility bills this summer. Later, Producer Matt plays Chris & Amy's most questionable comments from the past week in a new recurring segment.

Steve Wills, Senior Director of Regulatory Affairs with Ameren Missouri, joins the show to explain why you might see an increase on your utility bills this summer. Later, Producer Matt plays Chris & Amy's most questionable comments from the past week in a new recurring segment.

Europe Notified Body survey report - 31 October 2024 - What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf The MIR form has been updated - Version 7.3.1 - Don't use previous versions: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en   UK: UK MIR and FSCA - Change is in the AIR: https://www.gov.uk/government/publications/more-implementation/gb-mir-and-fsca-schema-implementation-guide UK MDR 2002 is dying - Long life to UK MDR 2025: https://www.legislation.gov.uk/ukdsi/2025/9780348269529 : Real-World Data or Clinical Trial or Both?- This is the question: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions     Training EU MDR Green Belt June 2025 - June 23rd, June 27th: https://school.easymedicaldevice.com/course/gb34/ eTraining on Vigilance and Audit preparation - Self-paced: https://school.easymedicaldevice.com/emd-course   ROW USA Q-Sub update  - New electronic template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-q-submissions   Brazil: SIUD or UDI in Brazil - Manual of Use in Portuguese: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/manual_siud_v01.pdf   Saudi Arabia: Series of Webinar - June is a Busy month in Saudi Arabia: 16 June 2025 Companion Diagnostic Regulatory Requirements: https://www.sfda.gov.sa/en/workshop/3540492 17 June 2025 Saudi Unique Device Identification (SAUDI-DI): https://www.sfda.gov.sa/en/workshop/3540493 19 June 2025 Artificial Intelligence and Machine Learning: https://www.sfda.gov.sa/en/workshop/3540495 23 June 2025 Digital Health Medical Devices regulatory approach: https://www.sfda.gov.sa/en/workshop/3540496 24 June 2025 Medical Devices Risk Classification: https://www.sfda.gov.sa/en/workshop/3540497 Saudi In-house Devices - Not like EU: https://www.sfda.gov.sa/sites/default/files/2025-05/MDS-G022En.pdf   Turkey: In Turkey, Economic Operators are Liable - Even after discontinuation or temporary stop of supply: https://titck.gov.tr/duyuru/tibbi-cihazlarin-tedarikinin-kesintiye-ugramasi-veya-durdurulmasi-sona-ermesi-durumunda-i-ktisadi-i-sletmecilerin-yukumlulukleri-hakkinda-duyuru-21052025113350   PODCAST: Podcast Nostalgia - What happened in May 2025 Episode 334 - What is the new UK Post-Market Surveillance Requirements? With Claire Dyson: https://podcast.easymedicaldevice.com/334-2/ Episode 335 - When is Regulatory Affairs needed during Design? With Aouda Ouzza: https://podcast.easymedicaldevice.com/335-2/ Episode 336 - is EHDS dangerous for Medical Device Manufacturers? With Cecile van der Heijden: https://podcast.easymedicaldevice.com/336-2/ Episode 337 - How Deepeye Medical overcame the AI Act? With Carmen Bellebna; https://podcast.easymedicaldevice.com/337-2/ Episode 338 - Trapped or Strategic? Changing Notified Bodies During MDR transition: https://podcast.easymedicaldevice.com/338-2/  

This episode of the Ohio Ag Net Podcast brings together the latest in livestock leadership, soil health, and farm policy updates impacting Ohio producers. Dusty Sonnenberg and Joel Penhorwood lead a timely conversation with Duane Stateler and Pat Hord – two Ohio hog producers now serving in key leadership roles with the National Pork Producers Council with Stateler currently servicing as President and Hord as Vice President. They dig into major industry topics including Prop 12 implications, biosecurity threats like screwworm, and how Ohio farmers are helping shape national pork policy. Joel also catches up with Amy Weaver of Farm Credit Mid-America to learn more about the Growing Forward Program – designed to support young, beginning, and small farmers with tailored resources and opportunities. Then, Dusty chats with Kate Shenk, Director of Regulatory Affairs with Clean Fuels Alliance America, about compelling new research on biodiesel's benefits – findings with a major upside for Ohio's agricultural economy. Finally, Joe Everett and Brianna Smith talk soil strategy with Dr. Manbir Rakkar of The Ohio State University. With rain-soaked fields and delayed planting on many minds, Dr. Rakkar discusses when waiting just a bit longer might be the healthiest option for your soils in the long run, though far easier said than done.

Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video Linkedin Post: https://www.linkedin.com/feed/update/urn:li:activity:7331974765156384769/  Team NB position paper transfer agreement: https://www.team-nb.org/wp-content/uploads/2025/01/Team-NB-PositionPaper-TransferAgreement-v02-20240702-with-instructions.pdf  MDCG 2022-4: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-4_en.pdf  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

The food safety watchdog is proposing a measure that would see all food premises publicly display signage to show the level of cleanliness and food safety standards of the business.How would the roll out work?Joining Kieran to discuss is Adrian Cummins, CEO of the Restaurant Association of Ireland and Gail Carroll, Director of Regulatory Affairs and Compliance at the FSAI.

How does risk assessment fit into EUDR compliance? In this episode of our EUDR series, Jayne Stewart is joined by experts Luke Gwenter and Karen Ngo to break down the role of risk evaluation in meeting the EU Deforestation Regulation. Tune in for practical insights and key takeaways to strengthen your compliance strategy.Speakers:Jayne Stewart- Scientific Consultant, Regulatory Affairs and Dietary Intakes, Food & Nutrition Group, Food & Nutrition Group, Intertek AssurisKaren Ngo- Manager, Toxicology & Dietary Intakes, Food & Nutrition Group, Intertek AssurisLuke Gwenter- Associate Dietary Intakes, Food & Nutrition Group, Intertek AssurisFollow us on- Intertek's Assurance In Action || Twitter || LinkedIn.

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.  Who is Carmen Bellebna?  Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye's QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment.     Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Carmen Bellebna LinkedIn:  https://www.linkedin.com/in/men-be-a1828a81/   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/ 

Highlights from May's Global Update, from the Global Technical and Regulatory Affairs team at the Almond Board of California, detail the latest in the complex world of tariffs, examining the recent 90-day pause on reciprocal tariffs between the U.S. and China, and the potential impacts on the supply chain. Hear about the significant trade deal announced by President Trump on May 8, which promises new market access in the UK for American products. Additionally, learn about the European Parliament's decision to postpone the new due diligence and sustainability reporting requirements application dates.Finally, get the latest outreach efforts in Turkey and Morocco, where the team participated in the Tuksiad conference and conducted the first Almonds 101 workshop in Casablanca. Discover how Turkey's almond imports have surged from 77 million pounds in 2020 to over 151 million pounds in 2025 and learn about the optimistic outlook for further growth as the port of Mersin expands its capacity. Meanwhile, in Morocco, the workshop provided valuable insights into import procedures and fostered new collaborations with local industry stakeholders.

In this episode of Seen & Herd, Paul Sousa, Director of Environmental Sustainability and Regulatory Affairs at Western United Dairies, recaps a significant "doubleheader" of meetings held on Cinco de Mayo—a CDFA hearing on Stop QIP Petition #5 and an afternoon Producer Review Board (PRB) meeting. He breaks down procedural updates, introduces new board members, discusses quota administration issues, and explores the intriguing possibility of using a state bond to retire quota. Paul also provides important guidance on ballot signature requirements ahead of June's upcoming referendum and dives into a tense series of hardship relief requests. Stay informed on how these developments may shape the future of the quota program in California.Resources:> Previous Episode: Breaking Down Quota Results with Anja Raudabaugh> CDFA Producer Record Update Form

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we'll let you know when and why you should involve them earlier. Listen to this episode.  Who is Aouda Ouzzaa?  Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD).  Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations.  As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges.  Whether you're developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success.    Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32  SmartQARA website: https://smartqara.com/  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/  

U.S. EPA has made a concerted effort over the past several years to come into compliance with its obligations under the Endangered Species Act. Much of its efforts are driven by what is referred to as the Mega Suit by environmental groups, which are forcing deadlines on EPA to meet its obligations. During Potato Expo 2025, we sat down with two policy experts to talk about what the implementation of EPA's strategy will mean for growers.Guests: Mike Aerts, Vice President of Science and Regulatory Affairs, Florida Fruit & Vegetable AssociationMike Wenkel, Chief Operating Officer, National Potato CouncilThis podcast is possible thanks to our presenting sponsor, Syngenta. Delivering solutions to help producers face the potato industry's complex challenges, Syngenta provides growers with unmatched field expertise along with an array of effective products. Explore syngenta-us.com/spud-doctor to discover solutions for your potato-growing obstacles. 

Decades of trickle-down thinking hollowed out our government—and now the anti-democracy crowd is finishing the job. This week, legal scholar and former Biden advisor K. Sabeel Rahman joins Nick and Goldy to talk about what happens when the rule of law becomes optional, what the Biden administration got right (and what it didn't,) and why simply restoring the old system isn't enough. If we want a real democracy—one that can stand up to corporate power and actually deliver for people—we need to stop playing by outdated rules and start constructing a government that's faster, fairer, and fit for the modern world. K. Sabeel Rahman is a legal scholar, policy expert, and former senior advisor in the Biden administration, where he served as Associate Administrator at the Office of Information and Regulatory Affairs. A leading voice on democracy, governance, and economic justice, he is Demos's former president and a law professor at Cornell University. Social Media: ⁠@ksabeelrahman.bsky.social⁠ ⁠@ksabeelrahman⁠ Further reading:  ⁠Civic Power: Rebuilding American Democracy in an Era of Crisis⁠ Website: ⁠http://pitchforkeconomics.com⁠ Instagram: ⁠@pitchforkeconomics⁠ Threads: ⁠pitchforkeconomics⁠ Bluesky: ⁠@pitchforkeconomics.bsky.social⁠ Twitter: ⁠@PitchforkEcon⁠, ⁠@NickHanauer⁠, ⁠@civicaction⁠ YouTube: ⁠@pitchforkeconomics⁠ LinkedIn: ⁠Pitchfork Economics⁠  Substack: ⁠The Pitch⁠

Earl Adams Jr., Vice President for Policy and Regulatory Affairs, Plus joined Grayson Brulte on The Road to Autonomy podcast to discuss how autonomous trucking is poised to transform local communities, economically, socially, and operationally. In Texas, Plus is actively working to deploy fully autonomous trucks in partnership with International by 2027. As part of the preparation for launch, Earl is meeting with community leaders, elected officials and community colleges in an effort to build transparency and trust with the local communities. When autonomous trucks are deployed, they will make our roads safer and they will have a positive economic benefit on society. The economic benefits of autonomous trucking will be felt in local communities as they will strengthening local businesses through increased spending in local communities.Autonomous trucking isn't just about moving freight, it's about creating opportunity without debt, while revitalizing communities, one route at a time.Episode Chapters0:00 Autonomous Trucking Policy4:20 Economic Impact of Autonomous Trucking5:58 Public Trust10:51 Community Colleges12:28 Impact on Society17:29 California DMV Autonomous Trucking Rulemaking 22:48 Hours of Service 27:57 Building & Maintaining Trust35:21 Autonomous Trucking Industry 40:35 Key Takeaways Recorded on Wednesday, April 30, 2025--------About The Road to AutonomyThe Road to Autonomy provides market intelligence and strategic advisory services to institutional investors and companies, delivering insights needed to stay ahead of emerging trends in the autonomy economy™. To learn more, say hello (at) roadtoautonomy.com.Sign up for This Week in The Autonomy Economy newsletter: https://www.roadtoautonomy.com/autonomy-economy/See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Tuesday on AOA, powered by Cenex, we start the show with a look at this red-hot cattle market with Kyle Bumsted from Allendale. In Segment Two, we look at a new economic impact report commissioned by Clean Fuels Alliance America and get an update on 2026 RVO's with Kate Shenk, Director of Regulatory Affairs for Clean Fuels. In Segment Three, we get an update on the latest trends in the Meat Demand Monitor for April with Glynn Tonsor from Kansas State University. (Find the report here: https://agmanager.info/livestock-meat/meat-demand/monthly-meat-demand-monitor-survey-data) Then, we close the show discussing spring pests and Tick Awareness Week with Dr. Jim Fredericks from the National Pest Management Association.

Our recent SAM Huddle, Thinking Clearly in Uncertain Times, was recorded on April 21, 2025. With tensions around trade and cross-border relations rising, this conversation brought together industry and policy perspectives to delve into how these developments are reshaping the landscape for travel and resort operations throughout North America. This is episode two of our two-part series covering this conversation.  The J-1 visa program is facing potential cuts, prompting resorts to diversify recruitment strategies. While the program currently remains viable for the upcoming season, H-2B visas are being considered as a more stable—albeit costlier—alternative. Many resorts are preparing to use both to cover seasonal staffing needs.  Plus, efforts to streamline the National Environmental Policy Act or NEPA process are also underway, with more responsibility placed on project sponsors to prepare documentation. Staffing shortages at the federal level are causing some delays, leading to increased use of third-party contractors. But, projects that can align with forest health and wildfire mitigation goals may gain added momentum. Speakers: Dave Byrd, Director of Risk and Regulatory Affairs, NSAA Scott Prior, Senior Associate, Environmental and Permitting, SE Group Nate Riccardi, Pabian Law Listen to part 1 of the conversation here.

In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode. Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS's application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS's international team developing accessible content to support manufacturers with the regulatory pathways and transitions. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. - Links from the Video Claire Dyson LinkedIn:  Claire Dyson | LinkedIn  Blogs – 3 part series on U vs UK PMS   UK PMS Regulations: Overview & Key Requirements for Medical Device Safety  UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements  UK PMS vs EU MDR – Key Differences & Impact on CE-Marked Medical Devices  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/

Today on the Digging in Podcast. Kayden Guymon, MOFB's Director of Regulatory Affairs & Policy Counsel sits down to talk about the "Purple Paint Law" and how landowners can use this law to notify the general public of when they are approaching privately owned land. Subscribe wherever you listen to podcasts to have Digging In sent directly to your smart device each time it's released! Host: Janet Adkison, Missouri Farm Bureau Director of Public Affairs Guest: Kayden Guymon, Missouri Farm Bureau Director of Regulatory Affairs & Policy Counsel Producer: Jacob King, Missouri Farm Bureau Video & Audio Media Specialist

Jaya Tiwari, Senior Vice President of Clinical and Regulatory Affairs at XVIVO, which is focused on improving organ preservation for transplantation. Current organ preservation methods using ice coolers limit the time and distance organs can be transported.  XVIVO's perfusion technology can significantly extend the preservation time of hearts, kidneys, livers, and lungs, providing hospitals and transplant centers access to more viable organs. The company is passionate about increasing organ availability to give more patients access to life-saving transplants. Jaya explains, "I take it back to 1967 when the first heart transplant was performed in Cape Town, and the way that the heart was preserved and transported in essentially an ice box. The standard of care for the preservation of organs is still an ice or an ice cooler with ice. So, this decreases metabolic activities. So, to try to preserve the organs so that you can get them from the donor to the recipient, the problem is that the organs are not viable for a very long time, and they start to degrade very quickly. That really limits the amount of time that the organs can be on ice, transported from the donor to the recipient hospital. Because of that logistical complexity, a lot of organs are ultimately not transplanted." "There have been some preclinical studies that we've done that have shown viability of the heart tissue for up to 24 hours. But what I think is probably the most remarkable example that we've seen is that the universities in Paris have put together something called an investigator-initiated study, where they actually were able to transport a donor heart from the French West Indies to Paris for transplant. That was about 12 hours that the heart was in transport and using the device. So that's remarkable because that essentially tripled the standard preservation time for hearts. Now, in the US, we have a clinical trial where we're currently seeking approval from the FDA that it's safe and effective to use this device for up to 12 hours." #XVIVO #HealthcareInnovation #LifeSavingTechnology #PatientOutcomes #OrganTransplantation #OrganTransplants xvivogroup.com Download the transcript here

Jaya Tiwari, Senior Vice President of Clinical and Regulatory Affairs at XVIVO, which is focused on improving organ preservation for transplantation. Current organ preservation methods using ice coolers limit the time and distance organs can be transported.  XVIVO's perfusion technology can significantly extend the preservation time of hearts, kidneys, livers, and lungs, providing hospitals and transplant centers access to more viable organs. The company is passionate about increasing organ availability to give more patients access to life-saving transplants. Jaya explains, "I take it back to 1967 when the first heart transplant was performed in Cape Town, and the way that the heart was preserved and transported in essentially an ice box. The standard of care for the preservation of organs is still an ice or an ice cooler with ice. So, this decreases metabolic activities. So, to try to preserve the organs so that you can get them from the donor to the recipient, the problem is that the organs are not viable for a very long time, and they start to degrade very quickly. That really limits the amount of time that the organs can be on ice, transported from the donor to the recipient hospital. Because of that logistical complexity, a lot of organs are ultimately not transplanted." "There have been some preclinical studies that we've done that have shown viability of the heart tissue for up to 24 hours. But what I think is probably the most remarkable example that we've seen is that the universities in Paris have put together something called an investigator-initiated study, where they actually were able to transport a donor heart from the French West Indies to Paris for transplant. That was about 12 hours that the heart was in transport and using the device. So that's remarkable because that essentially tripled the standard preservation time for hearts. Now, in the US, we have a clinical trial where we're currently seeking approval from the FDA that it's safe and effective to use this device for up to 12 hours." #XVIVO #HealthcareInnovation #LifeSavingTechnology #PatientOutcomes #OrganTransplantation #OrganTransplants xvivogroup.com Listen to the podcast here

Are Google and Facebook screwed? That's the question which Keith Teare asks in today's That Was The Week tech newsletter. In our age of nationalist globalization, Teare argues, Facebook and Google, the original darlings of the Web 2.0 revolution are, so-to-speak, half-fucked. On the one hand, they are the victims of a legal witch hunt by a nationalist U.S. government intent on punishing Big Tech innovation; on the other, they continue to reap the benefits of an increasingly globalized digital marketplace. No wonder, then, that Lee-Anne Mullholland, the Google VP of Regulatory Affairs, has claimed a kind of Trumpian half-victory in this week's legal ruling against her company. “We won half of this case and we will appeal the other half,” Mullholland wrote. Perhaps. But as Teare drolly remarks in his editorial, “nobody can accuse the Government of being fast.” No, not even half-fast. In this absurdly anachronistic fight against Google and Facebook, the snail-paced U.S. government is actually fighting the war before the last war. The only Big Tech thing that matters in 2025 is artificial intelligence. And retroactively breaking up half-archaic companies like Meta or Google isn't going to make much difference in today's all-important race to control tomorrow's A.I. economy. * Google and Meta (Facebook) are facing significant antitrust challenges. Meta is undergoing a trial questioning the legitimacy of their acquisitions of Instagram and WhatsApp from 2012 and 2014, while Google has been found guilty of maintaining an advertising monopoly.* Both Keith and Andrew discuss how the government's antitrust actions seem to come too late, with Keith describing it as "government overreach" and noting that "Nobody can accuse the government of being fast," calling these cases against actions from a decade ago "shocking."* Keith argues that these companies are facing existential threats from technological shifts, not just legal challenges. He notes that Google's core business of cost-per-click advertising is shrinking both in usage and revenue per click, and faces additional challenges in the AI era where ads don't fit neatly with AI results.* Then there's China. Keith and Andrew discuss about the decline of Western technological dominance and the rise of the Chinese economy, with references to a shift toward "de-globalization" at the political and military level while economic globalization continues.* They discuss the potential future impact of AI on employment and social structures, with Keith noting that the "unknown unknown" is "the impact of AI on employment and abundance," suggesting two possible futures: either a utopia where "nobody needs to work and everyone can eat, live, feed, be entertained" or an "apocalypse where it's a hellscape for anyone that isn't rich."Keen On America is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit keenon.substack.com/subscribe

Summary: At the heart of any successful self-care business is a portfolio of recognizable and trusted consumer health brands. These brands could play a key role in unlocking the potential of digital self-care in the UK, suggests Michelle Riddalls, in this second part of her Over the Counter interview. As PAGB CEO, Michelle has seen first had how the UK consumer health industry has been transformed, for example also by Brexit. Has the UK's exit from the EU realised the promises of innovation unleashed from bureaucracy? Not so far, Michelle reflects, but it might be too soon to tell. What she can predict is that with its new five-year strategy, PAGB will remain dedicated to supporting UK firms in navigating a continuously evolving industry landscape. Timestamps 2:00 – Digital consumer health in the UK 7:00 – The power of brands 12:00 – Brexit, promise realised? 20:00 – What's next for the UK OTC industry? Guest Bio Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King's 2025 New Year Honours.

In this episode, join scientific consultants Lois Haighton, Jayne Stewart, and Luke Gwenter from Intertek's Food & Nutrition Assuris Group as they explore the requirements for filing a Due Diligence Statement under EUDR.  Tune in as they discuss the due diligence statement or DDS, which is one of the 3 necessary conditions for EUDR compliance, in order to import or export relevant products to or from the EU market. Don't miss this informative podcast on navigating compliance in an evolving regulatory landscape!Speaker:Lois Haighton- Senior Director, Toxicology & Project Operations, Food & Nutrition Group, Intertek AssurisJayne Stewart- Scientific Consultant, Regulatory Affairs & Dietary Intakes, Food & Nutrition Group, Intertek AssurisLuke Gwenter- Associate Dietary Intakes, Food & Nutrition Group, Intertek Assuris Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.

OIRA — the Office of Information and Regulatory Affairs — is an obscure, but powerful federal office around the corner from the White House. President Trump has decided that it should get even more powerful.For the last 45 years, OIRA has overseen most federal agencies by reviewing proposed regulations to make sure they agree with the President's policies and don't conflict with the work of other agencies. But one set of federal agencies has always been exempt from this review process — independent federal agencies like the SEC, FTC, FCC, and Federal Reserve. Until now.According to a new executive order, those independent agencies are about to get a lot less independent. We take a look at what this change could mean for financial markets...and the future of American democracy.This episode was produced by James Sneed and Willa Rubin. It was edited by Jess Jiang and engineered by Jimmy Keeley. It was fact-checked by Sierra Juarez. Alex Goldmark is our executive producer.Find more Planet Money: Facebook / Instagram / TikTok / Our weekly Newsletter.Listen free at these links: Apple Podcasts, Spotify, the NPR app or anywhere you get podcasts.Help support Planet Money and hear our bonus episodes by subscribing to Planet Money+ in Apple Podcasts or at plus.npr.org/planetmoney.Music: Universal Music Production - "Tanga," "The Jump Back," and "Kumbatia."Learn more about sponsor message choices: podcastchoices.com/adchoicesNPR Privacy Policy

In this episode of the Almond Byte, the Almond Board of California's Global Technical and Regulatory Affairs team highlights two major regulatory developments shaping almond exports.First, a major milestone for U.S. almond trade with Japan: USDA and Japan's Ministry of Health, Labor & Welfare have signed a voluntary aflatoxin pre-testing protocol. Years in the making, this agreement significantly reduces Japan's inspection frequency for protocol participants, helping streamline exports and reduce costs. The episode discusses how handlers can participate and what to expect from implementation.Then, we shift to the European Union, where the European Commission recently unveiled its “Vision for Agriculture and Food.” In response to last year's farmer protests, the EU is moving toward tighter import controls — emphasizing mirror clauses, food safety, pesticide regulations and sustainability requirements for imported goods.

Just weeks before the summer concert season kicks off, President Trump recently signed an executive order to combat ticket scalping in the live entertainment industry.   Despite efforts from several past presidents and lawmakers to address this issue, ticket scalping continues to be a significant problem. Further, the soaring costs of some tickets have been a major headache for music, theater, and sports fans.   Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, recently spoke with FOX News Rundown host Chris Foster to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry.   Wall also explained how ticket pricing works, who collects the widely hated added fees, and what is being done to combat scalpers and bots.   We often must cut interviews short during the week, but we thought you might like to hear the full interview.   Today on Fox News Rundown Extra, we will share our entire interview with Live Nation's Dan Wall and let you hear more about his take on the live entertainment industry and what can be done to give fans some relief.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Just weeks before the summer concert season kicks off, President Trump recently signed an executive order to combat ticket scalping in the live entertainment industry.   Despite efforts from several past presidents and lawmakers to address this issue, ticket scalping continues to be a significant problem. Further, the soaring costs of some tickets have been a major headache for music, theater, and sports fans.   Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, recently spoke with FOX News Rundown host Chris Foster to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry.   Wall also explained how ticket pricing works, who collects the widely hated added fees, and what is being done to combat scalpers and bots.   We often must cut interviews short during the week, but we thought you might like to hear the full interview.   Today on Fox News Rundown Extra, we will share our entire interview with Live Nation's Dan Wall and let you hear more about his take on the live entertainment industry and what can be done to give fans some relief.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Just weeks before the summer concert season kicks off, President Trump recently signed an executive order to combat ticket scalping in the live entertainment industry.   Despite efforts from several past presidents and lawmakers to address this issue, ticket scalping continues to be a significant problem. Further, the soaring costs of some tickets have been a major headache for music, theater, and sports fans.   Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, recently spoke with FOX News Rundown host Chris Foster to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry.   Wall also explained how ticket pricing works, who collects the widely hated added fees, and what is being done to combat scalpers and bots.   We often must cut interviews short during the week, but we thought you might like to hear the full interview.   Today on Fox News Rundown Extra, we will share our entire interview with Live Nation's Dan Wall and let you hear more about his take on the live entertainment industry and what can be done to give fans some relief.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Join us for our special edition show bringing on guests from reputable organizations and companies based in Canada. As many know, CPG is alive and well in Canada with many brands that are growing in their home country and many entrepreneurs choose to expand to the United States and abroad.We will be bringing on (in no particular order)Sonia Parmar - VP of Reg Affairs & Gov Relations for CHFAJules Gorham - Director of Regulatory Affairs & Policy for CHFASteve Dontigny - Foundry President Megan Silk - Co-Founder of GingerBug Robert Cogan - Owner of Power Full Energy DistributionThis episode is also sponsored by Power Full Energy Distribution.

In this episode of The Med-Tech Talent Lab podcast, host Mitch Robbins interviews Mary McNamara-Cullinane, Vice President of Regulatory Affairs at ClearPoint Neuro, about her 25+ year journey in the medical device regulatory space.Key Highlights:Mary shares her background as the youngest of eight children and how her early work ethic shaped her career pathLearn how Mary transitioned from research to regulatory affairs through roles at Brigham and Women's, CRBARD, and a 17-year consulting careerDiscover what makes an outstanding regulatory professional in today's environmentUnderstand the challenges regulatory executives face when balancing company goals with regulatory requirementsPractical Takeaways:Why proactive research and understanding the "why" behind regulations separates exceptional regulatory professionalsThe importance of managing leadership expectations around FDA timelinesWhy submitting complete FDA submissions is more efficient than rushing deficient onesThoughts on remote work effectiveness in regulatory rolesMary also discusses ClearPoint Neuro's exciting work with gene therapy companies and their recent partnership with PTC Therapeutics to address rare diseases in children.Whether you're a regulatory professional looking to advance your career or an executive trying to better understand the regulatory landscape, this conversation offers valuable insights from a seasoned industry leader.Mary McNamara-Cullinane on LinkedIn: https://www.linkedin.com/in/marymcnamaracullinane/ClearPoint Neuro on the web:https://www.clearpointneuro.com/

On this episode of the Scouting For Growth podcast, Sabine VdL talks to Lisa Bechtold, global executive and strategic leader in technology and law who currently serves at the head of AI governance from a transformative viewpoint at Zurich Insurance Group. In this episode, we explore the challenges and opportunities of the current AI transformation, what it takes to drive innovation in insurance while minimizing potential risks about AI, the role of digital trust and sustainability in leveraging AI for long-term growth, and how leaders can prepare their teams for the digital transformation ahead of us. KEY TAKEAWAYS AI governance is about how we use AI, which already affects all areas of our private and business lives. The acceptance and potential success of AI applications, tools and use cases correlate with the respect of legal systems and the culture of the country or region. With the tools, systems and platforms we’ve built at Zurich, we’ve driven and scaled AI adoption, including the reuse of solutions which have proven extremely successful. In parallel, we drive AI literacy to foster adoption, but also to ensure AI tools are being used in an optimal way. For example, setting the right prompts is crucial for generating the most valuable output from GenAI tools. On one hand, we invest in the education of our workforce, with digital upscaling and AI literacy in particular. On the other hand, it’s crucial to allow for experimentation in a safe sandbox environment so that everyone is embrace the technological opportunities. Insurance has always been a data-driven industry, so the adoption of AI techniques is very well founded in insurance, from risk modelling to all phases of the insurance business value chain. Looking ahead, with the AI revolution taking place this year, both opportunities and risks will be taken to another level. Today,AI systems are beginning to autonomously interact with one another and adapt their behaviours accordingly. I expect, as things increase within both the interaction of individual AI agents as well as in the creation of high-performance, multi-agent systems. Such multi-agent systems bring a multitude of business opportunities but also trigger challenges, such as potential information asymmetries and miscoordination, all of which need to be understood and managed. BEST MOMENTS ‘The goal of deploying AI solutions must be to optimise the benefits of the technology while effectively minimising the risks.’‘AI governance is the foundation of being a catalyst of AI innovation and ensures high-quality outcomes and inspires trust in customers.’‘Today we’re focusing on the scalability and further optimisation of our AI capabilities.’‘Managing the complexity of multi-agent systems in a safe and lean way while optimising business value will be one of the key priorities for 2025.’ ABOUT THE GUEST Lisa Bechtold: As a Global Executive and Strategic Leader and Leader in Technology & Law, I have profound expertise and experience in Data, AI, Governance, Digital Risk and Regulatory Affairs to protect corporate assets and optimise business performance. In my current role as Head of AI Governance at Zurich Insurance Group, I have pioneered and led the operationalisation of a framework for AI Quality & Safety to oversee the development and deployment of AI solutions globally. My multifaceted background positions me perfectly to provide strategic advice on data, digital solutions, and technology topics, integrating legal & risk considerations, to generate sustainable business value and digital trust as a competitive edge. LinkedIn ABOUT THE HOST Sabine is a corporate strategist turned entrepreneur. She is the CEO and Managing Partner of Alchemy Crew a venture lab that accelerates the curation, validation, & commercialization of new tech business models. Sabine is renowned within the insurance sector for building some of the most renowned tech startup accelerators around the world working with over 30 corporate insurers, accelerated over 100 startup ventures. Sabine is the co-editor of the bestseller The INSURTECH Book, a top 50 Women in Tech, a FinTech and InsurTech Influencer, an investor & multi-award winner. Twitter LinkedIn Instagram Facebook TikTok Email Website

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA.  Who is Cyrille Michaud?  Co-founder and managing partner of MD101 Consulting. Consultant in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices. Specialties: Software Processes Management. CE Mark & FDA 510k 21 CFR 820 - ISO 13485 - ISO 14971 - IEC 62304 - IEC 62366 - IEC 60601 - IEC 82304-1 - UL 2900-1 - IEC 81001-5-1 Agile Methods applied to medical device software design. Cybersecurity applied to medical devices. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Cyrille Michaud LinkedIn:  https://www.linkedin.com/in/cyrillemichaud/  MD101 : www.MD101.io  Trainings on Cybersecurity : https://blog.cm-dm.com/pages/Medical-Device-Software-Trainings  Blog post sur cyber et normes : https://blog.cm-dm.com/post/2023/10/06/Final-2023-FDA-Premarket-Cybersecurity-guidance-released  FDA resources on cybersecurity : https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity IG NB checklists : https://www.ig-nb.de/veroeffentlichungen (page in German but download links in the page are in English)  Standard IEC 81001-5-1 and 81001-5-2: https://blog.cm-dm.com/post/2024/10/04/IEC-81001-5-2%3A-AAMI-SW96-cousin-and-IEC-80001-5-1-sister  Blog IEC 81001-5-1: https://blog.cm-dm.com/post/2024/02/23/IEC-81001-5-1-Right-Here-Right-Now 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

President Trump's "Liberation Day," tariffs have been announced, and some Americans fear the results. The Trump administration is sticking to its guns, aiming to see countries come to the table and companies reset their supply chains. President Trump's Department of Government Efficiency continues its pursuit of cutting government waste while slashing money that goes towards diversity, equity, and inclusion grants. Senator Marsha Blackburn (R-TN) joins the Rundown to discuss President Trump's tariffs and his effort to address waste, fraud, and abuse in the federal government. She also relays an important message to the people of Tennessee after devastating storms impact their state.  Last week, President Trump signed an executive order aimed at combating ticket scalping in the live entertainment industry. Despite efforts from several past presidents to reform this issue, ticket scalping continues to be a significant problem. Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, joins to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Exerting maximum influence on stakeholders, helping companies navigate regulatory complexity and promoting industry best practice are three big jobs that the UK consumer healthcare industry association, PAGB, has set itself for the next five years. In the last five years, PAGB has made significant headway with UK government, reports PAGB CEO Michelle Riddalls, establishing the economic and social value of self-care and ensuring that self-care is part of the UK's national healthcare strategy. Rx-to-OTC switch has been a major area of success, Michelle notes in this episode of the Over the Counter podcast. The Department of Health and Social Care recently published a list of switches it would like to see applications for, and PAGB is now facilitating members to take advantage of this opportunity. But there's always more work to be done. Switch involves significant risk, which PAGB is trying to reduce through further work with policy makers, and with a new government, the association must ensure that self-care remains high up on the agenda for politicians. Given the breadth of PAGB's work discussed by Michelle, we have split this episode into two, so watch out for the second part in two weeks' time on your favourite podcast provider and on Citeline's HBW Insight. Timestamps 2:10 – Introductions 2:40 – PAGB's new five-year strategy 5:40 – Evolution not revolution 8:00 – Self-care and UK government policy 10:30 – Quantifying the value of self-care 12:30 – Lobbying around AMR and OTCs 16:00 – Rx-to-OTC switch in the UK 24:00 – The power of brands Guest Bio Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King's 2025 New Year Honours.

President Trump's "Liberation Day," tariffs have been announced, and some Americans fear the results. The Trump administration is sticking to its guns, aiming to see countries come to the table and companies reset their supply chains. President Trump's Department of Government Efficiency continues its pursuit of cutting government waste while slashing money that goes towards diversity, equity, and inclusion grants. Senator Marsha Blackburn (R-TN) joins the Rundown to discuss President Trump's tariffs and his effort to address waste, fraud, and abuse in the federal government. She also relays an important message to the people of Tennessee after devastating storms impact their state.  Last week, President Trump signed an executive order aimed at combating ticket scalping in the live entertainment industry. Despite efforts from several past presidents to reform this issue, ticket scalping continues to be a significant problem. Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, joins to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

President Trump's "Liberation Day," tariffs have been announced, and some Americans fear the results. The Trump administration is sticking to its guns, aiming to see countries come to the table and companies reset their supply chains. President Trump's Department of Government Efficiency continues its pursuit of cutting government waste while slashing money that goes towards diversity, equity, and inclusion grants. Senator Marsha Blackburn (R-TN) joins the Rundown to discuss President Trump's tariffs and his effort to address waste, fraud, and abuse in the federal government. She also relays an important message to the people of Tennessee after devastating storms impact their state.  Last week, President Trump signed an executive order aimed at combating ticket scalping in the live entertainment industry. Despite efforts from several past presidents to reform this issue, ticket scalping continues to be a significant problem. Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, joins to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

If President Trump's tariff strategy succeeds in sparking a revival in US manufacturing, one consequence will be surging demand for power. We are already seeing electricity demand starting to pick up after 15 years of stagnation, driven by new data centers for AI and a wave of factory-building for semiconductors and batteries that is already under way. How can the electricity industry increase capacity to meet that growing demand and provide the power that the country needs?That's the question for this special episode of the Energy Gang, recorded live in front of an invited audience at the headquarters of the American Clean Power association in Washington DC. Host Ed Crooks talks to Chris Shelton, the Chief Product Officer at AES, Travis Kavulla, the Vice-President for Regulatory Affairs at NRG Energy, and MJ Shiao, the Vice President of Supply Chain and Manufacturing at American Clean Power.They discuss whether electricity demand growth is really happening, which technologies are best placed to provide new supply, and who will end up paying for the investment needed to increase capacity. The Trump administration's focus has been on “baseload” power, particularly new natural gas power plants. But there are reasons why they cannot be a complete solution. Renewable energy and battery storage also have important roles to play.The group also assess the impacts of changing energy policies under a Republican administration and Congress. What will be the fate of tax credits for low-carbon energy under the Inflation Reduction Act? And will moves to expedite permitting and environmental approvals make it easier to build all kinds of new infrastructure, including power and energy facilities, in the US?See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

As the world increasingly moves toward cleaner energy solutions, the demand for long-duration energy storage is at an all-time high. Hydrostor, a global leader in compressed air energy storage, is addressing this challenge by providing scalable, efficient, and sustainable alternatives to traditional battery technology. In this episode of Alternative Power Plays, hosts Alan Seltzer and John Povilaitis speak with Scott Bolton, Executive Vice President of Global Policy and Regulatory Affairs at Hydrostor. They discuss how the company's innovative storage technology is helping to stabilize power grids around the world. Scott explains the mechanics of compressed air energy storage and compares it to lithium-ion batteries and pumped hydro, illustrating why this technology is positioned to play a crucial role in the transition to clean energy.The conversation also highlights Hydrostor's flagship projects—the Silver City Energy Center in Australia and the Willow Rock project in California—showing how these large-scale storage solutions meet various energy market needs. Additionally, Scott addresses the regulatory challenges that Hydrostor faces, discusses how they collaborate with policymakers to facilitate energy storage deployment, and shares insights on the future of energy infrastructure development.To learn more about Hydrostor, visit: https://hydrostor.ca/ To learn more about Scott Bolton, visit: https://www.linkedin.com/in/scott-bolton-72489/To learn more about Alan Seltzer, visit: https://www.bipc.com/alan-seltzer⁠   To learn more about John Povilaitis, visit: ⁠https://www.bipc.com/john-povilaitis

We're excited to welcome Oeystein Kjoersvik to AI Uncovered. Oeystein leads the Generative AI program within the Quality Assurance team at Merck, where he focuses on developing AI tools and applying a quality-first approach to ensure safe, effective use of AI in GxP-regulated environments.In this episode, Tim and Oeystein delve into the challenges of adopting AI in regulated settings, the complexity of validating GenAI tools, and the transition from traditional processes to AI-augmented systems. They also explore Oeystein's work with the IMPALA Consortium and the importance of cross-industry collaboration to identify and scale high-value use cases for Generative AI.Before his current role, Oeystein served as a Product Owner in Analytics at Merck IT, building analytics platforms and integrating data science across systems. He also contributed as a Machine Learning Subject Matter Expert to TransCelerate's Intelligent Automation Group, advancing AI applications in pharmacovigilance.Oeystein brings a rare blend of technical expertise and regulatory insight. He's passionate about helping teams adopt AI responsibly and transparently—ensuring innovation aligns with quality across the pharmaceutical landscape.Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

In episode 74 of Revamping Retirement, hosts Jennifer Doss and Pete Ruffel discuss governmental affairs with Scott Eckel, Managing Director of Legislative and Regulatory Affairs at Charles Schwab. Scott discusses his role as a lobbyist and they cover key issues such as financial regulations, e-delivery of documents, and the new administration's potential impact on tax reform and retirement policies. Scott also touches on the budget reconciliation process and its implications.

Join us for an insightful episode of Seen & Herd as we welcome back Paul Sousa, Western United Dairies' Director of Environmental Sustainability and Regulatory Affairs. Paul dives into the latest regulatory updates, including recent changes to CARB's air quality rules, ongoing water quality discussions, and what dairy producers should prepare for in the coming years. Plus, we highlight the upcoming California Dairy Sustainability Summit and why it's a must-attend event for the industry.Tune in to stay informed, and don't forget to check the links in the show notes for more details, including access to past episodes and registration info for the summit.> Click HERE to hear Paul's previous update.> Click HERE to read WUD's SWRCB Dairy Order Comments> Click HERE to learn more about the Dairy Sustainability Summit

March's Almond Byte brings you the latest insights from the Almond Board of California's Global Technical and Regulatory Affairs team. This month, ABC made waves at Gulfood 2025, connecting with key buyers and exploring future opportunities in Dubai's expanding trade landscape. Meanwhile, new tariffs on Chinese imports are impacting the global almond market, with retaliatory duties adding more challenges for exporters. On the opportunity front, Morocco's booming almond demand is creating exciting prospects for U.S. growers, while an upcoming exploratory trip to Turkey aims to strengthen ties with major processors. Stay tuned for more details on these industry-shaping developments.

Athena GTX has been at the forefront of innovative medical technology since its founding in 2003, originally developing solutions for military applications. Today, the company serves a diverse range of industries, bringing cutting-edge patient monitoring systems to high-risk environments. Sean Mahoney, VP of Engineering and Regulatory Affairs, joins us to share an exclusive look at Athena GTX's newest product and the complex journey of bringing it to market. With stringent FDA regulations and a responsibility to safeguard personal health data, Athena GTX operates within one of the most challenging regulatory landscapes in med-tech. In this episode, Sean walks us through the rigorous development process, from prototype to commercialization, and how Athena GTX ensures compliance without stifling innovation. We explore the future of wearable medical technology, the intersection of military and civilian healthcare applications, and the company's role in shaping next-generation patient monitoring. Whether you're in healthcare, technology, or manufacturing, this conversation provides valuable insights into navigating regulatory challenges while driving innovation forward. Hear the full show: https://iowapodcast.com/sean-mahoney-athena-GTX    

Dean's Chat hosts, Drs. Jensen and Richey, welcome Dr. Gerit D. Mulder to the podcast!  Dr. Mulder gave Dr. Jensen an opportunity to join his practice at the Wound Healing Institute after residency, providing a tremendous foundation for future research that included the National Institutes of Health, and Department of Defense opportunities.  Dr. Mulder has a storied history in podiatric medical research in the wound care space.  He received his BS at University of Redlands; a masters degree from Cal State - San Bernadino, then received his DPM from the College of Podiatric Medicine. He received his PhD from Chulalongkorn University through University of California San Diego specializing in Biomedical Sciences/Stem Cells.  Gerit speaks 5 languages and has taught wound care, and implemented wound care programs around the world.  Tune in for a fabulous interview! Below is a brief history of Dr. Mulder's activities and qualifications: • Extensive expertise in the development, implementation and management of clinical trials, clinical operations and teams.  Experience as a lead Principal Investigator interacting with and guiding multicenter trials.  Direct interaction with the FDA, Pharmaceutical Industry and Academic Research Centers.  Focus on Inflammatory Diseases, Dermatology and Infectious Disease.  • Responsible for development and oversight than 120 clinical trials. • Supervised, educated, and guided research teams globally. • Developed project budgets, protocols, guidelines, and implementation plans for developing wound clinics. • Provided strategic and tactical input to the medical industry related to clinical trials with emphasis on Phase 1,2 and 3 studies.  • Created tissue and wound repair programs to increase product understanding to assist Emerging Markets. Additional Expertise and Affiliations Include: • Understanding of Regulatory Affairs. • International experience with monitoring and overseeing clinical trials. • Served as a national and international  • Provided input on new product development for novel disease states.  • Conversational skills in English, Spanish, Italian, French, and German • Extensive experience with KOLs and medical advisory boards. Physician at Christus St. Vincent Medical Center, Wound & Hyperbaric Center. December 2021 to current. • Provide advanced clinical care for chronic wounds of all etiologies including diabetic, venous, pressure, trauma and other wounds. • Direct wound and tissue repair and regeneration research Medical Research Consultant – Independent 2019 – current Clinical Tissue Repair and Regeneration Specialist – 2019-current • Consult internationally on Phase 1,2, and 3 clinical trials • Provide input for development and implementation of clinical trials and educational materials for health care providers related to phase 1, 2 and 3 studies as well as approved products. • Provide clinical care to patients with acute and chronic wounds of all etiologies Director, Professor of Surgery and Orthopedics University of California San Diego Medical Center, Wound Treatment and Research Center   April 1998- December 2013 •  Provided clinical and surgical care, conducted medical student, resident and staff education, oversaw clinical research.  Treated more than 3000 patients per year.  Published in peer reviewed medical journals and key presenter at medical conferences globally. • Oversaw research within my division of the Department of Trauma, with focus on tissue regeneration and repair, inflammatory and infectious related diseases and cell regeneration. June 1986-April 1998: President of WCI (Wound Consultants Inc., previously Wound Healing Institute)    WCI offered consulting services to the biotechnology and pharmaceutical industry related to clinical protocols and trials, implementation of related patient care, planning and managing medical education.  Advised on development of new products related to tissue regeneration and repair. Patient Care    Vice President of Marketing and Medical Affairs DermaRx  May 1995- March 1998 Vice President of Clinical and Regulatory Affairs Organogenesis, Inc.   May 1994-May 1995     Wound Clinic Director Veterans Administration Hospital Denver June 1983- Jne 1992 FDA Experience: • Participated as an advisor to the FDA and companies working with the FDA • Completed and submitted 510k for hydrogel, foam, and other wound treatment devices • Completed clinical section of PMA submission on Apligraf for Organogenesis • Consulted as wound care expert on panels for medical and pharmaceutical industry. • Chaired Human Subjects Committee in Denver for two years for a major IRB. • Interacted with FDA on Dermatology and Inflammatory Diesease Dr. Mulder can be reached at (619) 417-9249 or at gerit.mulder@gmail.com;  gerit.mulder@stvin.org  or on LinkedIn at http://www.linkedin.com/pub/gerit-mulder/a/321/6b5

Join us for an in-depth discussion with three different perspectives on the future of energy. We'll explore the potential impacts of Trump's policies on renewable energy, fossil fuels, and the environment. With the Inflation Reduction Act (IRA) driving historic clean energy investments, we're at a critical juncture as Trump begins his second term. Tune in as we navigate the complex landscape of the energy industry's future.The solar industry has proven its resilience time and again. During Trump's first term, solar capacity in the U.S. surged by 128%, exceeding 100 GW despite a federal focus on fossil fuels, according to SEIA. That same spirit of adaptation is palpable today, as the clean energy sector braces for a second term marked by deregulation, energy “trade-offs,” and a growing corporate appetite for renewables. David Roberts, respected journalist and progenitor of Volts.wtf, explores the unpredictability of the Trump's energy policies and how coalitions have become a vital counterbalance to federal uncertainty. Travis Kavulla, Vice President of Regulatory Affairs at NRG Energy, provides a detailed look at regulatory developments, including the potential impact of Chris Wright's leadership at DOE and how the Federal Energy Regulatory Commission's (FERC) evolving role could shape market dynamics.Aaron Nichols, Marketing and Advocacy Specialist at Exact Solar, scoured dozens of articles on the subject and reflects on how Trump's initial term unexpectedly mobilized the solar industry, sparking collaboration that continues to fuel growth. Despite the challenges, there are significant opportunities. Corporate renewable investments, driven by the AI boom and energy-hungry data centers, are reshaping market demand. Industry coalitions are demonstrating the power of collective advocacy in influencing policy and preserving growth. Federal agencies like FERC and DOE are at the forefront of decisions that could redefine the balance between fossil fuels and clean energy. The solar sector is once again proving its resilience, channeling innovation and determination to meet the moment.With Inauguration Day just around the corner, the direction of U.S. energy policy hangs in the balance. Will deregulation spur clean energy growth, or will shifting priorities pose new challenges? Tune in to find out more.If you want to connect with today's guest, you'll find links to his contact info in the show notes on the blog at https://mysuncast.com/suncast-episodes/.Our Platinum Presenting Sponsor for SunCast is CPS America!SunCast is proudly supported by Trina Solar.You can learn more about all the sponsors who help make this show free for you at www.mysuncast.com/sponsors.Remember, you can always find resources, learn more about today's guest and explore recommendations, book links, and more than 730 other founder stories and startup advice at www.mysuncast.com.Subscribe to Valence, our weekly LinkedIn Newsletter, and learn the elements of compelling storytelling: