Podcasts about Regulatory affairs

In this episode of Current Account, Clay is joined by IIF's Andrés Portilla, Managing Director of Regulatory Affairs, and Katie Rismanchi, Deputy Director of Regulatory Affairs, to talk about banking supervision - namely developments and recent trends in how supervision is approached across the globe. The discussion begins with a key question: Why is banking supervision important? The podcast continues with a discussion on the response to supervisory turmoil in recent years, issues and flaws within current supervisory procedures and processes, potential solutions to aid in increased supervisory effectiveness and transparency, how progress can be - and may already have been - measured and much more. For more information about this topic, read the IIF's recent paper on supervisory effectiveness here. This IIF Podcast was hosted by Clay Lowery, Executive Vice President, Research and Policy, with production and research contributions from Christian Klein, Digital Graphics and Production Associate and Miranda Silverman, Senior Program Assistant.

bersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence. In this article (based on the podcast episode), we explore: How to prepare cybersecurity documentation for audits and inspections Building post-market processes for vulnerability handling and reporting Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…) Managing supplier and open-source component risks Implementing and maintaining an SBOM Key trends like the NIS2 Directive and the EU AI Act

In this episode of the RWS Clinician's Corner, Margaret Floyd Barry takes us behind the scenes into the dynamic world of research and curriculum development in the functional health space. Margaret sits down with two of Restorative Wellness Solutions' powerhouse instructors, Ellen Lovelace and Paige Reagan, for a candid conversation about the challenges, surprises, and daily realities of translating emerging science into practical, safe, and effective tools for clinicians.   In this interview, we discuss:     -Specific ways that Ellen & Paige demonstrate curriculum leadership and research support for RWS   -How to respond to new studies or challenges to existing curriculum    -How to decide which sources to trust   -How to evaluate clinical research (red & green flags)   -Addressing research limitations and gaps    -Using research tools and AI in gathering evidence   The Clinician's Corner is brought to you by Restorative Wellness Solutions.  Follow us: https://www.instagram.com/restorativewellnesssolutions/    Connect with Ellen:  Website: www.abalancedtable.net Facebook: www.facebook.com/abalancedtable Instagram: www.instagram.com/abalancedtable   Connect with Paige: Website: www.naturallynourishedwellness.com Instagram: www.instagram.com/paigereaganntp   Timestamps: 00:00 From Russian Studies to Health Advocacy 07:56 Curriculum Accuracy and Depth Focus 12:57 Using AI for Study Validation 19:20 Evaluating Research Article Credibility 25:24 Animal Study Relevance and Limitations 28:03 "Pediatric Research Gaps in Drug Trials" 33:55 "Teaching Deepens Understanding" 41:17 Questioning AI for Balanced Answers 44:47 Effective Research Strategies and AI Limitations 52:04 Verify Before Believing Headlines 55:52 "Unpaywall: Access Free Academic Papers" 01:00:33 "The Clinician's Corner Podcast" Speaker bios: Ellen Lovelace, Lead Instructor & Curriculum Development Master RHP, MPH, FNTP, Board Certified in Holistic Nutrition® Ellen (she/her) has been actively working to educate and improve the public's health for almost 20 years. Ellen received her Masters in Public Health from The George Washington University, and went on to run everything from tuberculosis prevention programs in Russia to dental health education programs along the Texas/Mexico border. She was also the founding Executive Director of the women's health program at Stanford University. When Ellen became drawn to a more holistic model, she received her certifications as a Nutritional Therapy Consultant and a Master Restorative Health Practitioner. She is the owner of A Balanced Table Nutritional Therapy in San Jose, CA, her private functional nutrition practice. Ellen focuses on cutting through the confusion and nutrition “noise,” digging to the roots of clients' dysfunction, and figuring out the best way for them to eat, drink, and thrive. She uses the IRH functional analysis tools daily, and is excited to share her passion for these methods. Ellen believes that only by focusing on root causes, combined with whole foods nutrition, can true wellness be achieved. Ellen is also a passionate animal lover who volunteers at a wildlife rescue facility, and can often be found smelling of skunk while covered in Mastiff drool.    Paige Reagan, Instructor and Research Master RHP, FNTP Paige has spent most of her career working in Research and Development in the areas of clinical research, regulatory affairs, and medical writing. She has a wide range of experience in the therapeutic areas of cardiovascular health, pulmonary arterial hypertension, diabetes, bone health, osteoarthritis/rheumatoid arthritis, and urology, among others. Her work has contributed to numerous regulatory approvals as well as publications in major medical journals such as the New England Journal of Medicine, Lancet, Circulation, and American Heart Journal. Paige has since earned certifications as a Functional Nutritional Therapy Practitioner and Master Restorative Health Practitioner. She is owner of Naturally Nourished Wellness, a small practice specializing in gut health and the downstream effects of poor digestion. She strives to find balance between the holistic and mainstream approaches and aims to provide her clients with the best of both worlds, using her critical thinking skills from years in research combined with objective laboratory testing and her passion for the restorative power of whole foods and simple lifestyles. She spends her free time exploring the outdoors with her family, swinging kettlebells, and creating baked goods with healthier ingredients.   Keywords: functional nutrition, public health, research process, curriculum development, clinical research, regulatory affairs, medical writing, gastrointestinal healing, lab testing, food sensitivities, evidence-based practice, study design, randomized controlled trials, observational studies, animal studies, peer review, PubMed, Google Scholar, AI tools in research, ChatGPT, consensus, study citations, clinical anecdote, sample size, funding bias, meta-analysis, systematic reviews, biostatistics, clinical protocols, dietary supplements   Disclaimer: The views expressed in the RWS Clinician's Corner series are those of the individual speakers and interviewees, and do not necessarily reflect the views of Restorative Wellness Solutions, LLC. Restorative Wellness Solutions, LLC does not specifically endorse or approve of any of the information or opinions expressed in the RWS Clinician's Corner series. The information and opinions expressed in the RWS Clinician's Corner series are for educational purposes only and should not be construed as medical advice. If you have any medical concerns, please consult with a qualified healthcare professional. Restorative Wellness Solutions, LLC is not liable for any damages or injuries that may result from the use of the information or opinions expressed in the RWS Clinician's Corner series. By viewing or listening to this information, you agree to hold Restorative Wellness Solutions, LLC harmless from any and all claims, demands, and causes of action arising out of or in connection with your participation. Thank you for your understanding.  

The FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olympus, Covidien, JUUL Labs, and others, Marcus brings a unique perspective to what makes a quality organization truly high-performing.Marcus shares why compliance is only the baseline “entry fee” for quality—and how high-functioning teams go further by protecting a company's right to compete, preventing manufacturing and supply disruptions, enabling speed to market, and building trust across the business.He discusses the metrics that matter most (like defect rates, back orders, holds, complaints, and R&D delays), how to structure incentives that drive the right behaviors, and practical strategies for recruiting, onboarding, and retaining people with the drive, courage, and creativity to lead meaningful change.Nick and Marcus also explore how leaders can create the right balance of accountability and innovation, foster collaboration across functions, and ensure quality is seen as a value-driving partner rather than a cost center or policing function.About The FDA Group: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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

The latest episode of Parsing Immigration Policy features Elizabeth Jacobs, Director of Regulatory Affairs and Policy at the Center for Immigration Studies, discussing USCIS's updated guidance on discretion in immigration benefits.Key Points:Beyond “Not a Criminal”: New USCIS policy updates require officers to engage in a more holistic analysis of whether naturalization applicants demonstrate “good moral character,” a requirement for naturalization that has been a part of U.S. immigration law since the beginning. In addition, the agency is now asking officers to consider any anti-American, antisemetic, or terrorist activity as “overwhelmingly negative” factors when evaluating whether an applicant warrants a positive grant of discretion.Discretionary Benefits: Many immigration benefits under the INA — including asylum, national interest waivers under EB-2, and naturalization — are discretionary. Even if eligibility requirements are met, USCIS officers may deny them.Good Moral Character Assessments:Traditionally treated as a checklist; now assessed holistically.Focuses on demonstrating positive attributes and rehabilitation, not just the absence of misconduct.Negative Factors for Discretionary Denials: Officers are instructed to treat support for anti-American ideologies, antisemitism, and terrorism as “overwhelmingly negative factors” when exercising discretion on discretionary immigration benefit requests.Expanded Use of Vetting Tools:Increased use of social media screening, fraud detection, and neighborhood/personal investigations.Previous policies often waived these investigations; the update clarifies they are a standard part of discretion.Balancing Efficiency and Vetting: With millions of applications annually, USCIS must balance rigorous vetting with timely processing. The agency is shifting culture to prioritize serving the American people, not just applicants.Cultural Shift: USCIS is shifting emphasis from serving as a “service agency” to serving as a vetting agency, using the discretion granted by Congress to protect national security and uphold American values — a departure from prior policies favoring mass approvals.Immigration Newsmaker Interview: USCIS Director Joe Edlow will be featured today in an Immigration Newsmaker conversation hosted by CIS at the National Press Club. The video will be available at cis.org.Host Mark Krikorian is the Executive Director of the Center for Immigration Studies.GuestElizabeth Jacobs is the Director of Regulatory Affairs and Policy at the Center for Immigration Studies.RelatedUSCIS to Consider Anti-Americanism, Antisemitism, and Terrorist Activity When Adjudicating Certain Immigration Benefit RequestsCIS National Security Vetting Failures DatabaseIntro MontageVoices in the opening montage:Sen. Barack Obama at a 2005 press conference.Sen. John McCain in a 2010 election ad.President Lyndon Johnson, upon signing the 1965 Immigration Act.Booker T. Washington, reading in 1908 from his 1895 Atlanta Exposition speech.Laraine Newman as a "Conehead" on SNL in 1977.Hillary Clinton in a 2003 radio interview.Cesar Chavez in a 1974 interview.House Speaker Nancy Pelosi speaking to reporters in 2019.Prof. George Borjas in a 2016 C-SPAN appearance.Sen. Jeff Sessions in 2008 comments on the Senate floor.Candidate Trump in 2015 campaign speech.Charlton Heston in "Planet of the Apes".

As global regulatory expectations evolve, biotech sponsors face growing pressure to make smarter, earlier decisions about where and how to run their trials. In this episode, Novotech experts Renita Hite (Director of Regulatory Affairs, Drug Development Consulting) and Scott Schliebner (Global Head of Drug Development Consulting) join moderator Meredith Landry to discuss how early-stage sponsors can adapt to shifting FDA initiatives, accelerated global pathways, and increasing demands for regulatory flexibility. They explore: How new FDA initiatives—like AI-driven reviews, user fee changes, and the National Priority Voucher—are reshaping IND strategy Why sponsors should design trials with global data packages in mind from day one Accelerated and early access pathways that can speed startup and market entry How CROs are evolving to help sponsors prioritize markets and build regulatory flexibility If you're planning trials for 2025 and beyond, this conversation will help you prepare for what's next—and position your program for long-term success. About This Episode This episode is the final installment (4 of 4) in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Catch up on earlier episodes: [Part 1: Navigating Regulatory Changes & Market Dynamics] [Part 2: Navigating Regulatory & Market Shifts] [Part 3: Navigating Regulatory Changes & Market Dynamics]

In this episode, Leslie Bellas, Vice President, Regulatory Affairs, American Fuel and Petrochemical Manufacturers (AFPM), discusses the U.S. EPA's recent RFS proposal, including costs, feedstock challenges and a simple change to cut regulatory costs, among other items.

On this episode of the SeventySix Capital Sports Leadership Show - College Sports Edition, Wayne Kimmel and Co-Host Ken Shropshire interviewed Professional and Collegiate Sports Executive, Oliver Luck.As President of Palmetto Trust Company, LLC and Chairman of Altius Sports Partners, Luck provides leadership experience spanning collegiate and professional athletics. His roles have included Commissioner of the XFL, Executive Vice President for Regulatory Affairs and Strategic Partnerships of the NCAA, and Athletic Director of West Virginia University.Additionally, Luck has been in leadership roles with the Houston Dynamo of Major League Soccer and the National Football League and was Chief Executive Officer of the Harris County-Houston Sports Authority, where he oversaw the financing, construction and management of professional sports and entertainment infrastructure in Houston, including Minute Maid Park, Reliant Stadium and Toyota Center.Chapters00:00 Introduction to Oliver Luck02:16 The Evolution of College Sports and NIL07:21 Unionization and Collective Bargaining in College Sports12:26 The Importance of Education and Financial Literacy20:15 Title IX and Gender Equality in Sports25:47 Maximizing Revenue for Olympic Sports30:29 The Future of College Sports Management32:12 Looking Ahead: The Future of College Athletics

This episode is part of our EEI 2025 Highlights series. In this episode, you will hear conversations about keeping costs as low as possible for customers, how drones are enhancing electric company operations, advanced nuclear, and new technologies that are strengthening grid resilience. The speakers are: Mary Sprayregen, Global Head of Regulatory Affairs & Market Development, Oracle Utilities Tom Keefe, Vice Chair and Power, Utilities & Renewables Sector Leader for Deloitte Chris Levesque, President and CEO, TerraPower Duke Austin, President and CEO, Quanta  You can also visit EEI's website to read EEI 2025 recap newsletters, see photos from our annual thought leadership forum, and watch videos from some of the keynotes.

The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one directly impacts growth, culture, and execution.Listeners will learn how to:Pressure-test whether your strategy is actually winnable.Match organizational capabilities to goals (and pivot when they don't).Use KPIs and OKRs to diagnose execution gaps.Build stronger trust and culture through connectedness, from “gemba” walks to multi-channel communication.Sean also shares real-world stories—from transforming an underperforming ultrasound launch to shifting a company's culture from “play not to lose” to “play to win.” Whether you're leading in medtech, life sciences, or beyond, this episode delivers actionable insights you can bring straight back to your team.About the Guest:Sean Gallimore, MBA is an executive consultant with 30 years of leadership across Fortune 500, mid-cap, and private equity–backed companies in medical devices, life sciences, and industrial technology. He has held senior roles at Medtronic, Smith & Nephew, Philips, Parexel, PDI Healthcare, and Dynisco, driving growth through strategy execution, turnarounds, innovation, and building high-performing teams. Today, he advises early-stage medtech companies on scaling operations, commercial strategy, and organizational development.About The FDA Group: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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

Summary Nel nuovo episodio del nostro podcast, parliamo di un tema spesso percepito come tecnico e complesso, ma in realtà sempre più strategico: il mondo del Regulatory nei rivestimenti industriali. Ne discutiamo con Alice Paiotta, Regulatory & Quality Assurance Manager Europe in Carboline, che ci guida in un viaggio tra REACH, sostenibilità, rischi normativi, competitività e innovazione. Timestamps 00:53 – Introduzione 01:16 – Presentazione dell'ospite: Alice Paiotta 02:03 – Che cos'è il regulatory in un'azienda che produce rivestimenti e prodotti antincendio 02:40 – I principali regolamenti applicabili in Europa 03:34 – Focus sul Regolamento REACH 04:21 – Le autorità competenti in Europa per il settore dei rivestimenti 05:44 – Come è evoluta la regolamentazione negli ultimi decenni 08:22 – Codice UFI: di cosa si tratta e a cosa serve 08:53 – Il futuro del regulatory secondo Alice 10:46 – L'aggiornamento delle liste di sostanze: un processo continuo 11:14 – Regolamenti europei e sostenibilità: sempre più interconnessi 13:33 – Le conseguenze della non conformità normativa (legali, economiche, reputazionali) 16:20 – Come assicurarci di non commercializzare prodotti non conformi 19:25 – Regulatory come vantaggio competitivo: quando la conformità diventa strategia 22:50 – Le principali sfide da affrontare per restare conformi 24:48 – Il percorso di Alice: dalla chimica al regulatory 28:02 – Domande extra per chiudere in leggerezza

In this episode we talk about bio-diesel, where it is used and how it is cleaner than diesel of old. Fun fact, today's diesels have cleaner air coming out of the tail pipe than the air going in. The pretty awesome Ford Explorer ST and talk with our listener family  

In this episode we talk about bio-diesel, where it is used and how it is cleaner than diesel of old. Fun fact, today's diesels have cleaner air coming out of the tail pipe than the air going in. The pretty awesome Ford Explorer ST and talk with our listener family  

Have you ever wondered what it's really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world. Adam's journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising. What you'll discover in this episode:

Host Jim Tate talks to Kristen Valdes, Founder, CEO and Jill DeGraff, SVP of Privacy, Regulatory Affairs, and Compliance at b.well Connected Health. Time to explore the lack of enforcement of information blocking rules and "portalitis". You can definitely expect to hear a clear call for a way forward into true interoperability. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen

The FDA Group's Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a wide-ranging conversation about how real-world data is reshaping drug development, regulatory decisions, and public understanding of evidence.Dr. Stapff draws on decades of experience across medical affairs, clinical trials, and RWE analytics to explain why real-world evidence isn't a replacement for randomized controlled trials—but a necessary complement. He outlines how to transform raw data into credible evidence, how the FDA is using RWE today, and why quality, transparency, and context are essential in data-driven science.He also offers cautionary insight on common pitfalls—from bias in training data and misinterpreted statistics to the challenges of AI integration in healthcare research.What they cover:What real-world evidence is (and isn't)—and how it differs from clinical trial dataHow RWE is being used by the FDA to support label expansions and safety monitoringKey risks around self-reported data, upcoding, and poor data qualityWhy statistical significance isn't enough—and how to evaluate clinical relevanceHow AI can accelerate pattern recognition and predictive diagnosticsWhy training data matters—and how bias can infiltrate large-scale AI toolsThe role of educated skepticism in interpreting data-driven claims in both science and societyDr. Manfred Stapff is the founder and principal consultant at a boutique advisory firm focused on real-world evidence strategy, clinical development, and medical data intelligence. He is the author of Real World Evidence Unveiled and a frequent speaker on the role of data integrity, statistical literacy, and AI in advancing medical research. His current work supports life science companies and investors in evaluating drug development strategies, acquisition opportunities, and data-driven innovations.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

Welcome to Model Citizens: AI Compliance for Banks and Fintech Lenders, a six-part miniseries from the Fintech Takes podcast in partnership with FairPlay. In this series, I'm joined by FairPlay's Kareem Saleh (Founder & CEO) to explore how banks and fintechs can build fair, compliant lending systems in an era of regulatory uncertainty. Episode 1 tackles one of the biggest questions in financial services today: what happens when the top federal watchdog (that was/is the CFPB) loses its bite? Joined by David Silberman (former CFPB Associate Director for Research, Markets, and Regulation) and Abby Hogan (SVP of Legal & Regulatory Affairs; ex-CFPB), we explore the vacuum left by a defanged CFPB and the new patchwork of enforcement that's emerging in its place. Highlights include: Why 50-state compliance is the most expensive form of “deregulation” you've never asked for How pragmatic state regulators are becoming the new R&D lab for rulemaking since fintech innovation won't wait What the five-year lookback really means for compliance teams (hint: regulatory whiplash isn't a free pass to hit cruise control) Whether the CFPB could be rebuilt (and how fast the talent might come roaring back) This episode sets the stage for what's ahead. Because the future of fair lending isn't just about algorithms; it's about who's making the rules, who's watching, who's suing, and who's redrawing the lines of fairness and risk.  In other words: it's about what kind of model citizens we want our institutions (and our systems) to be. Don't forget to subscribe and catch more insights on Model Citizens in upcoming episodes! This miniseries is brought to you by FairPlay. FairPlay is an AI enablement company for financial services. They help companies build, test, optimize, validate and govern AI models. Learn more at Fairplay.ai Sign up for Alex's Fintech Takes newsletter for the latest insightful analysis on fintech trends, along with a heaping pile of pop culture references and copious footnotes. Every Monday and Thursday: https://workweek.com/brand/fintech-takes/ Follow Alex:  YouTube: https://www.youtube.com/channel/UCJgfH47QEwbQmkQlz1V9rQA/videos LinkedIn: https://www.linkedin.com/in/alexhjohnson Twitter: https://www.twitter.com/AlexH_Johnson Follow David: LinkedIn: https://www.linkedin.com/in/david-silberman-1143414a/ Follow Kareem: https://www.linkedin.com/in/kareemsaleh/ Follow Abby: https://www.linkedin.com/in/abbyhogan/ Learn more about FairPlay here.

From the passage of the “Big Beautiful Tax Bill”, to new laws around stablecoins, investors have been navigating one massive change after another as they chase the stock market to new record highs. Michael Townsend, the Managing Director of  Legislative and Regulatory Affairs for Charles Schwab tells us which policies will impact investors the most, and what new regulatory changes are looming on the horizon. Plus, private equity and capital are clawing their way into retail investors portfolios as the number of public companies continues to decrease. What could go wrong? Learn more about your ad choices. Visit podcastchoices.com/adchoices

In this episode of Skin Deep, I sit down with Mr Paul Naude, Head of Regulatory Affairs and Quality Management at Advanced Nutrition Programme, to celebrate the launch of their newest innovation,  Skin Integrate 28.Seven years in the making and backed by 46 clinical studies, this is not just another gut health powder. Skin Integrate 28 is a prebiotic-rich, science-led formulation designed to nourish your gut microbiome — the invisible ecosystem that holds the key to so much of our health, including the skin.Formulated with 23 plant fibres and polyphenols, three amino acids, zinc, and vitamin C, it's a powerhouse blend created to:▪️ Encourage digestive regularity▪️ Support skin clarity and reduce redness▪️ Strengthen the gut-skin axis▪️ Elevate energy, sleep, and overall resilienceThis episode explores the rising trend of nutrition powders, what sets Skin Integrate 28 apart, and why feeding the microbiome is the first and most vital step in supporting skin from within.If you're curious about gut health, skin inflammation, or simply want to feel better from the inside out , this is the episode for you.

On episode 242, we welcome Cass Sunstein to discuss the foundations of fame, the roles of information cascades and reputation cascades in fostering one's success, the rise of Obama as a cascade, whether talent is enough for sustainable success, how group polarization influences our perceptions, network effects and our dependence on others, the significance of luck, why talent doesn't always see the light of day, and the importance of cultivating a sense of pride and fun in our pursuits rather than pursuing fame. Cass R. Sunstein is the Robert Walmsley University Professor at Harvard Law School. From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs. Since that time, he has served in the US government in several different roles. Adviser to many nations and international organizations, he is the author of Nudge (with Richard H. Thaler), Noise (with Daniel Kahneman and Olivier Sibony), The World According to Star Wars, and Wiser (with Reid Hastie). We will be discussing his book, How to Become Famous: Lost Einsteins, Forgotten Superstars, and How the Beatles Came to Be.  | Cass R. Sunstein | ► Website | https://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=16333 ► Twitter | https://x.com/casssunstein ► BlueSky | https://bsky.app/profile/did:plc:yy5jieyfjpsugpkxcphmzica ► How to Become Famous Book | https://amzn.to/3TPAA9H Where you can find us: | Seize The Moment Podcast | ► Facebook | https://www.facebook.com/SeizeTheMoment ► Twitter | https://twitter.com/seize_podcast ► Instagram | https://www.instagram.com/seizethemoment ► TikTok | https://www.tiktok.com/@seizethemomentpodcast ► Patreon | https://bit.ly/3xLHTIa  

The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: the cost of quality.Dr. Garko shares why quality should be viewed not as a cost center but as a strategic investment—and how companies can embed that mindset into their culture, systems, and leadership practices. She outlines the difference between good and poor quality costs, explains how to build ROI-focused metrics, and offers practical ways to foster transparency, psychological safety, and proactive decision-making.From regulatory intelligence and scorecard design to audit readiness and AI integration, this conversation is packed with insights for quality leaders and executive teams alike.What they cover:How to shift your organization's mindset from compliance to value creationThe real financial and operational impact of poor vs. proactive qualityHow to build scorecards, systems, and reporting processes that drive actionWhy culture, transparency, and psychological safety are core to sustainable qualityPractical approaches to audit readiness, supplier oversight, and training_____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/

Today we were delighted to welcome Jack Belcher and Sarah Venuto of Cornerstone Government Affairs, along with Brook Papau, CEO of Orennia, for a discussion focused on the energy implications of the One Big Beautiful Bill (OBBB). Jack, a Principal at Cornerstone, has over 30 years of experience in energy and energy policy, having previously served as Manager of Regulatory Affairs and Policy at Shell and Staff Director for the U.S. House Subcommittee on Energy and Mineral Resources. Sarah, Principal and Counsel, joined Cornerstone in 2023 following roles as Director of the Office of External Affairs at the Federal Energy Regulatory Commission, Senior Advisor and Chief Counsel to Senator Joe Manchin, and Democratic Staff Director for the Senate Energy and Natural Resources Committee. Brook founded Orennia in 2021 and previously served as Managing Director at RS Energy Group (now Enverus). Between Jack, Sarah, and Brook, we had a wealth of insight and expertise that fueled a thoughtful and detailed conversation. In our discussion, we explore the implications of the OBBB for U.S. energy policy, including a shift in emphasis toward fossil fuels (particularly natural gas), along with a renewed focus on reliability and dispatchability. Jack shares his perspective on the “winners” (oil and gas, nuclear, geothermal, and hydrogen) and “losers” (wind and solar), major changes to clean energy tax credits, and the pullback of unobligated funds from federal agencies reclaiming money originally authorized under the IRA. We discuss the introduction of Foreign Entity of Concern (FEOC) restrictions across tax credits, intended to accelerate the reshoring of critical supply chains, and how the current energy tax credit framework increasingly aligns with Trump Administration energy priorities. Brook shares implications for the U.S. grid and power mix, including anticipated delayed retirements of natural gas facilities, a near-term rush to install solar, wind, and storage while tax credits remain in place, severe supply chain constraints for new thermal generation, and growing post-2028 uncertainty as AI-driven demand growth threatens to outpace renewable power additions for the first time. Sarah describes the evolving U.S. energy policy landscape, with regulatory loosening across federal agencies, reduced enforcement capacity due to staffing cuts, and a return to traditional energy provisions, including reinstated onshore and offshore lease sales, lowered royalty rates, renewed support for drilling in Alaska, and accelerated tax treatment for intangible drilling costs. We examine the continued bipartisan support for nuclear, growing cross-party momentum for reshoring advanced manufacturing and critical supply chains, the inflation implications of phasing out tax credits, the partial permitting reforms included in the bill, the importance of codifying reforms into law to avoid policy reversals, early industry reaction to the bill, and much more. As mentioned, a few slides from Orennia's latest report on the OBBB are linked here. It was an engaging and insightful conversation, and we greatly appreciate Jack, Sarah, and Brook for sharing their perspectives. Mike Bradley opened the conversation by highlighting broader equity market performance, recent OPEC+ developments, and President Trump's surprising proposal to implement a copper import tariff. On the broader equity market front, markets have mostly moved sideways this week after posting all-time highs last week on passage of the One Big Beautiful Bill. Trumpatility is beginning to resurface ahead of President Trump's July 9th tariff deadline. Upcoming CPI and PPI reports, due next week, could significantly influence whether the Fed moves to cut interest rates at the July 30th FOMC Meeting. Additionally, Q2 reporting begins

Nick Capman talks with Marcia Baroni—a microbiologist with 27 years in global pharma-quality leadership—about reframing quality from a controllable expense to a strategic asset. Baroni contrasts “bad-quality” costs (scrap, recalls, deviations) with “good-quality” investments (testing, preventive controls, oversight) and explains why the latter pay for themselves in resilience and brand value. She illustrates the stakes with a $600 million nationwide OTC-drug recall caused by chemically treated pallets—an error frontline staff flagged but a weak quality culture ignored. The conversation dives into building psychological safety and metrics that drive the right behaviors, not under-reporting, shifting quality from “policing” to cross-functional partnership, and practical first steps executives can take to gauge their current maturity and start investing for future yield._____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/

ICE agents have begun concealing their identities in masks and plainclothes while making arrests. Experts—including a former ICE official—say that endangers those agents, and violates the trust between law enforcement and the citizenry. Guests: Philip Bump, columnist for the Washington Post Scott Shuchart, ICE's Assistant Director for Regulatory Affairs and Policy Counselor to the Director, 2022–2025. Want more What Next? Subscribe to Slate Plus to access ad-free listening to the whole What Next family and across all your favorite Slate podcasts. Subscribe today on Apple Podcasts by clicking “Try Free” at the top of our show page. Sign up now at slate.com/whatnextplus to get access wherever you listen. Podcast production by Ethan Oberman, Elena Schwartz, Paige Osburn, Anna Phillips, Madeline Ducharme, and Rob Gunther. Learn more about your ad choices. Visit megaphone.fm/adchoices

ICE agents have begun concealing their identities in masks and plainclothes while making arrests. Experts—including a former ICE official—say that endangers those agents, and violates the trust between law enforcement and the citizenry. Guests: Philip Bump, columnist for the Washington Post Scott Shuchart, ICE's Assistant Director for Regulatory Affairs and Policy Counselor to the Director, 2022–2025. Want more What Next? Subscribe to Slate Plus to access ad-free listening to the whole What Next family and across all your favorite Slate podcasts. Subscribe today on Apple Podcasts by clicking “Try Free” at the top of our show page. Sign up now at slate.com/whatnextplus to get access wherever you listen. Podcast production by Ethan Oberman, Elena Schwartz, Paige Osburn, Anna Phillips, Madeline Ducharme, and Rob Gunther. Learn more about your ad choices. Visit megaphone.fm/adchoices

ICE agents have begun concealing their identities in masks and plainclothes while making arrests. Experts—including a former ICE official—say that endangers those agents, and violates the trust between law enforcement and the citizenry. Guests: Philip Bump, columnist for the Washington Post Scott Shuchart, ICE's Assistant Director for Regulatory Affairs and Policy Counselor to the Director, 2022–2025. Want more What Next? Subscribe to Slate Plus to access ad-free listening to the whole What Next family and across all your favorite Slate podcasts. Subscribe today on Apple Podcasts by clicking “Try Free” at the top of our show page. Sign up now at slate.com/whatnextplus to get access wherever you listen. Podcast production by Ethan Oberman, Elena Schwartz, Paige Osburn, Anna Phillips, Madeline Ducharme, and Rob Gunther. Learn more about your ad choices. Visit megaphone.fm/adchoices

Confused by the new regulations and a patchwork of state-level policies? With a new administration setting fresh policy priorities, supply chains are facing shifting rules and growing pressure to adapt. Maggie Lyons, Vice President of Government and Regulatory Affairs at GS1 US, joins hosts Reid Jackson and Liz Sertl to decode the changes affecting how products are made, moved, and sold, and what businesses can do to stay ahead. From SNAP waivers and red dye bans to extended producer responsibility (EPR) laws and 2D barcodes, this episode breaks down how government decisions are impacting daily operations across food, retail, and consumer packaged goods (CPG). Maggie's team works with policymakers and industry leaders to align mandates with existing systems, helping avoid duplication and enabling efficient, standards-based implementation. In this episode, you'll learn: How state-level regulation is influencing national supply chain strategies Why new ingredient bans could create a ripple effect across CPG brands What you can do to stay ahead of policy changes impacting your industry Jump into the conversation: (00:00) Introducing Next Level Supply Chain (02:07) Why GS1 built a policy team (04:02) From Capitol Hill to CPG strategy (06:34) Staying focused amid constant regulatory shifts (08:48) Government agencies shaping supply chain standards (10:38) Customs, tariffs, and food assistance priorities (14:59) How SNAP waivers complicate retail operations (17:57) What red dye bans mean next   Connect with GS1 US: Our website - www.gs1us.org GS1 US on LinkedIn   Connect with the guest: Maggie Lyons on LinkedIn

This episode of the Green Report takes you inside the fast-paced world of the Texas Legislature with TNLA's Director of Legislative & Regulatory Affairs, Curtis Smith. From a record-setting water infrastructure win to stopping dangerous licensing and pesticide bills, Curtis breaks down how TNLA successfully defended the green industry at the Capitol. Plus, hear how TNLA members made a direct impact through advocacy and grassroots outreach—and what's next for protecting your business. For more information on TNLA and Advocacy, visit www.TNLAonline.org.

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/

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

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.

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.

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

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.

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

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.