Podcasts about Regulatory affairs

The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global medical device regulation. Main themes included: Updates on EU MDR/IVDR and new regulatory initiatives in France Structured dialogue with Notified Bodies and the harmonization of technical documentation Post-market discontinuation and the importance of anticipation for patient safety Eco-design and sustainability, bridging healthcare and environmental responsibility Software and AI in clinical investigations, and the use of real-world data Global market access – EU vs US pathways and MDSAP recognition Technical deep dives into ISO 13485, biocompatibility, usability, and cybersecurity The consensus was clear: regulatory pressure is increasing, but collaboration, innovation, and anticipation remain the keys to success. 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 Site web larentreedudm: https://www.larentreedudm.com Linkedin poste: https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381678647151112192-WQqX?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQhttps://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381670070097297408-80sP?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381641922739609600-HXhq?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381639827718447104-SQs-?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-regulatoryaffairs-easymedicaldevice-activity-7381629520535060480-kJ0p?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevices-regulatoryaffairs-easymedicaldevice-activity-7381602405030711296-aHcv?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ 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

In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way. We cover risk culture, CSV vs. data integrity, ALCOA++, data governance, and practical tips for newcomers. Key topics include: • Encouraging diverse perspectives to combat group think • Why data integrity is broader than CSV • The pyramid structure: data integrity at the top, CSV & validation as elements • ALCOA++ and traceability in real-world systems • Practical CSV and validation workflows • Common audit pitfalls and how to strengthen governance⏱ Timestamps00:00 – Intro: Group Think & Risk Appetite00:41 – Data Integrity in Consulting01:41 – Encouraging Diverse Perspectives02:37 – CSV vs Data Integrity03:13 – The Role of Data Stewards03:54 – The Pyramid: Data Integrity, CSV & Validation04:45 – ALCOA++ and Core Data Integrity Elements13:59 – Real Examples: CSV & Validation Workflows17:40 – Common Audit Pitfalls & Data Governance22:50 – Advice for Newcomers + Wrap-UpMonika is the Principal at Dunamis Compliance. She has over a decade of experience in formulating and executing strategies for data integrity and data governance assessments and remediation, risk management and computerized system validation within the pharmaceutical sector. She has worked within Quality, Technical Operations, Automation and Regulatory Affairs to execute and deliver compliant system solutions in regulated GXP environments.

On this episode, Pete and Julie welcome Ian P. Moloney, SVP and Head of Policy and Regulatory Affairs from the American Fintech Council, to break down the latest on the high-stakes legal battle over open banking. The Consumer Financial Protection Bureau's (CFPB) ruling under Dodd-Frank 1033 has sparked lawsuits, political maneuvering, and pushback from Big Banks, raising fundamental questions about who owns consumer financial data and who pays for access to it. Ian explains what's at stake as the rule is challenged, how fintech innovators and disruptors are responding, and why employees, consumers, and payroll professionals should care. From JP Morgan's recent data access fees announcement to the role of disruptors like SoFi, Affirm, and DailyPay, the discussion highlights how the outcome of this battle will shape the future of fintech partnerships, financial access, and the employee experience. Connect with Ian & the AFC: Ian's LinkedIn: https://www.linkedin.com/in/ianpmoloney/ AFC LinkedIn: https://www.linkedin.com/company/american-fintech-council/ AFC: https://www.fintechcouncil.org/ Connect with the show: LinkedIn:  http://linkedin.com/company/hr-payroll-2-0 X: @HRPayroll2_0 @PeteTiliakos @JulieFer_HR BlueSky: @hrpayroll2o.bsky.social YouTube: https://www.youtube.com/@HRPAYROLL2_0

In this episode, Uzair talks to Zeeshan Khattak, Commissioner at the Securities & Exchange Commission of Pakistan (SECP) about the deepening of financial markets in Pakistan and the ways in which the SECP is trying to expand access to finance at the individual and corporate level. Mr. Zeeshan Rehman Khattak joined the SECP as Commissioner in November 2024. He has over two decades of local and international experience in Real Estate Investment & Management, Regulatory Affairs, Wealth Management, and Development of Export-led Technology Infrastructure. Mr. Khattak brings rich experience in capital markets, regulatory oversight and assets' management. Mr. Khattak's most recent association was with Pakistan Software Export Board (PSEB) as Chief Commercial Officer and additionally as Chief Executive Officer designate. Chapters: 0:00 Introduction 2:20 SECP's priorities 11:25 Savings via digital gold 14:20 Regulatory sandboxes 25:05 Focus on startups 27:30 Climate finance

In this episode of the Intelligent Medicine podcast, Dr. Ronald Hoffman delves into the critical role of mitochondria in overall health with a particular emphasis on skincare with Dr. Julie Faitg, a mitochondrial biologist and senior manager of Applied Research and Regulatory Affairs at Timeline. The discussion highlights the broad impacts of mitochondrial health on lifestyle, diet, sleep, exercise, and psychological well-being. Focusing specifically on Urolithin A (MitoPure), they explore its promising benefits for muscle strength, endurance, and skin health through cellular renewal processes like mitophagy. Dr. Faitg emphasizes the clean formulation and clinical effectiveness of Timeline's various supplements and skincare products, underscoring their role in extending healthspan and rejuvenating skin from the outside in. The episode provides practical insights on product usage and the broader implications of mitochondrial science for anti-aging and wellness.

Dr. Hoffman continues his conversation with Dr. Julie Faitg, a mitochondrial biologist and senior manager of Applied Research and Regulatory Affairs at Timeline. 

Creating order from chaos: how a VP of Quality builds trust, leads through constraints, and keeps teams focused on patients.In today's episode Hemish was joined by Sep Naraghi, Vice President of Quality & Regulatory Affairs at Cellularity Inc.Sep has led quality in both Big Pharma and startups and has a practical, people-first approach to building trust, making trade-offs, and delivering under resource constraints.Sep's journey is anything but linear: from QC in generics to supplier quality at Boehringer Ingelheim, to leading quality and regulatory in a startup. His leadership philosophy is anchored in two values—trust and order—and he's candid about how feedback early in his career reshaped how he manages one-to-ones, builds transparency, and partners across the business.We talk about the following:Early path: QC in generics to supplier quality at Boehringer Ingelheim and an accelerated step into leadership.The two values that guide him—trust and order—and how childhood experiences shaped them.What changed in the industry: from “quality as police” to quality embedded early and driving value.Practical ways he learned softer skills: asking more questions, reading the room, and focusing on people in 1:1s.Big Pharma vs startup: resource constraints, creative problem-solving, and prioritising the ‘must-haves'.Keeping culture strong under pressure: transparency, bi-weekly team forums, and cross-functional partnership.Managing up and across: using a ‘ladder of inference,' lunch-and-learns, and making the logic visible.Hiring and fit for startups: flexibility, curiosity, blunt-but-respectful dialogue, and support from your boss.Creating order from chaos: bringing structure to reach IND/BLA milestones without losing speed.Advice for aspiring leaders: lean into discomfort; empathy over ego; and build trust before you need it.Sep Naraghi is a thoughtful, values-led leader who turns ambiguity into execution, champions transparency, and builds teams that do the right thing for patients and the business.Thank you Sep for sharing your incredible journey.Hope everyone enjoys the show!

In this conversation, Aidan Larkin sits down with Dr. Max Bernt (TaxBit) to explore the future of asset recovery in a digital-first world. They dive into how data aggregation, crypto, and stablecoins are transforming investigations - and why practitioners have reason for optimism. Timestamps00:00 – Introduction and Background 04:00 – Inside the Digital Asset Recovery Ecosystem 09:48 – How TaxBit Bridges On-Chain and Off-Chain Data 16:00 – Real-World Cases & Lessons Learned 27:50 – Tackling Data Challenges & Regulatory Hurdles 32:09 – Stablecoins: Risks and Opportunities 40:49 – The Future of Financial Crime Investigations 51:03 – Why There's Reason for Optimism in Recovery About our Guest Dr. Max Bernt is TaxBit's Global Head of Regulatory Affairs and Managing Director for Europe. With a robust background in transnational criminal law and extensive experience in regulatory affairs, he advises on cases and policy involving cryptocurrency, financial crime, and digital asset recovery. Max has helped shape discussions around the intersection of law enforcement and crypto, exploring how data aggregation, stablecoins, and regulatory frameworks impact investigations and compliance. Key Takeaways Evolving Asset Recovery Ecosystem: Technology is driving the evolution of the asset recovery ecosystem, creating new tools and approaches for practitioners. Importance of Data Aggregation: Effective investigations rely on robust data aggregation, helping practitioners identify patterns and trace assets efficiently. Bridging On-Chain and Off-Chain Data: TaxBit serves as a critical bridge between on- and off-chain data, enabling more accurate and comprehensive investigations. Impact of Regulatory Changes: Shifting regulations will have a significant effect on financial crime investigations, requiring practitioners to adapt strategies accordingly. Opportunities and Challenges of Stablecoins: Stablecoins present both opportunities and challenges for investigators, influencing how digital assets are tracked and recovered. Optimism for the Future of Asset Recovery: Despite the challenges, practitioners can be optimistic about future advancements, including improved efficiency, technology, and collaboration in the field. Resources Mentioned Taxbit Stay Connected Dive deeper into the world of asset recovery by subscribing to Seize & Desist: https://link.cohostpodcasting.com/b36b929c-6ca3-4e49-8258-44c310d012c9?d=sG5Qi2MdL DisclaimerOur podcasts are for informational purposes only. They are not intended to provide legal, tax, financial, and/or investment advice. Listeners must consult their own advisors before making decisions on the topics discussed. Asset Reality has no responsibility or liability for any decision made or any other acts or omissions in connection with your use of this material. The views expressed by guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent. Views and opinions expressed by Asset Reality employees are those of the employees and do not necessarily reflect the views of the company. Asset Reality does not guarantee or warrant the accuracy, completeness, timeliness, suitability or validity of the information in any particular podcast and will not be responsible for any claim attributable to errors, omissions, or other inaccuracies of any part of such material. Unless stated otherwise, reference to any specific product or entity does not constitute an endorsement or recommendation by Asset Reality.

Youth smoking in the United States has collapsed to historic lows, yet public health remains silent. At the same time, adult smokers are moving in record numbers to safer nicotine products, signaling a profound market shift that regulators struggle to keep pace with. In this episode of RegWatch, Dr. Chris Junker, Group Head of Life Sciences at British American Tobacco and former VP of Scientific & Regulatory Affairs at Reynolds American, discusses the FDA's slow-moving PMTA process, the collapse of youth smoking, and the importance of scientific transparency in tobacco harm reduction. From the unprecedented decline in youth smoking to the missed opportunities in public health, Junker provides a rare insider's perspective on how science, regulation, and consumer behavior collide in America's smokeless transition. Only on RegWatch by RegulatorWatch.com. https://youtu.be/Nw9WETlQQuQ Released: September 27, 2025 Produced by: Brent Stafford This episode is supported by DEMAND VAPE. Make RegWatch happen, go to https://support.regulatorwatch.com #RegWatch #VapeNews

H2O America (HTO) - Craig Patla, President & CEO - CT Water Service; Troy Dixon, VP Regulatory Affairs - CT Water Service - present at the Gabelli 3rd Annual PFAS Symposium. Moderated by Tim Winter, CFA (Portfolio Manager). To learn more about Gabelli Funds' fundamental, research-driven approach to investing, visit https://m.gabelli.com/gtv_cu or email invest@gabelli.com. Connect with Gabelli Funds: • X - https://x.com/InvestGabelli • Instagram - https://www.instagram.com/investgabelli/ • Facebook - https://www.facebook.com/InvestGabelli • LinkedIn - https://www.linkedin.com/company/investgabelli/ http://www.Gabelli.com Invest with Us 1-800-GABELLI (800-422-3554)

Post-Market Surveillance for Software & AI Devices – A QA/RA Guide Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital medical devices very different from traditional hardware. In this article, based on the podcast episode, we cover: How PMS differs for software, cloud, and AI-based devices Usage monitoring & anomaly detection through dashboards and KPIs Revalidation of updates and retrained AI algorithms Regulatory frameworks: EU MDR/IVDR, FDA's PCCP, IMDRF guidelines Supplier and infrastructure considerations A step-by-step PMS workflow for QA/RA teams Real-world case study on AI performance drift

Miquela Hanselman, Director of Regulatory Affairs with the National Milk Producers Federation, says the Whole Milk for Healthy Kids Act currently before Congress would give kids even more choices for the nutrition they need. NAFB News ServiceSee omnystudio.com/listener for privacy information.

In this episode of IDEA Collider, we are joined by Alex Telford, a biotech founder, writer, and thinker based in the San Francisco Bay Area. As the co-founder of Convoke Bio, Alex discusses his journey from studying biochemistry at UCL to founding a company that develops software tools for streamlining biopharmaceutical workflows.The conversation dives into the impact of AI and language models on the biotech industry, addressing inefficiencies in drug development, and exploring the potential of synthetic biology and personalized medicine. The discussion also touches on the future of drug discovery, China's role in biotech, and the challenges of understanding neuroscience and consciousness. Don't miss this insightful discussion on the future of biopharma innovation! 00:00 Welcome to Idea Collider00:04 Introducing Alex Telford01:59 Alex's Journey from UCL to Convoke Bio05:29 The Mission and Work of Convoke Bio07:57 Challenges in Pharma Decision Making14:05 The Role of AI in Pharma18:26 Knowledge Management and AI27:58 Staying Updated in the Fast-Moving AI Field30:25 AI's Impact on Industry Economics31:38 AI in Clinical Trials and Drug Development35:56 China's Role in Drug Discovery39:24 Neuroscience and AI: Blurring the Lines46:05 Future Predictions in Pharma51:20 Addressing Cognitive Bias in Pharma53:13 Concluding Thoughts and Future Directions Keep up with Alex Telford;LinkedIn: https://www.linkedin.com/in/alexander-telford/Website: atelfo.github.ioX: https://twitter.com/atelfoSubstack: atelfo.substack.com Follow Mike Rea On;Website: https://www.ideapharma.com/X: https://x.com/ideapharmaLinkedIn: https://www.linkedin.com/in/bigidea/ Listen to more fantastic podcast episodes: https://podcast.ideapharma.com/

In this episode, we bring together three food and nutrition experts to talk about the latest science behind foods and ingredients that pack a nutritional punch while tasting great. Dr. Kirstie Canene-Adams, director of Ingredion's Nutrition Center, Global Scientific and Regulatory Affairs, Dr. Lisa Sanders, owner and principal scientist at Cornerstone Nutrition, LLC and consulting … Continue reading Omnivore Presents: SciDish | Delivering Nutrition in Every Bite: The Science of Healthier, Tastier Foods | SEPT 2025 →

The FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to build the next generation of labs.Catherine explains the biggest challenges labs face today—like fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data, surface anomalies, and accelerate insights without replacing the people at the center of science. She outlines a step-by-step approach to identifying the right challenges, aligning AI projects with company strategy, piloting solutions with clear ROI, and managing change so teams embrace and sustain new tools.Nick and Catherine also discuss the balance between innovation and regulation, how to keep humans in the loop, and why strong governance and explainability are essential to ensuring AI adds real value in GLP environments.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 FDA Group's Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.Jeff shares why inspections feel less predictable today—with more variability in inspector experience and a higher likelihood that minor issues become formal observations—and how leaders can respond without overreacting. He explains how to prepare documentation so that it's understandable to any inspector, what makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance.Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don't overburden teams, and fostering engagement so quality is seen as a partner, not just a 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/

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.

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

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

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