Podcasts about Regulatory affairs

Are you using the right contract for your building projects in Texas?In this episode of the Your Project Shepherd Podcast, Curtis Lawson sits down with three industry leaders to unpack the value, structure, and legal protection behind TAB Contracts:Frances Blake – General Counsel & VP of Regulatory Affairs, Texas Association of BuildersAdam Aschmann – Senior Vice President & General Counsel, Tilson HomesDonald Shelton – Attorney/Shareholder, Bush Rudnicki Shelton, PCTAB (Texas Association of Builders) contracts are specifically written for residential construction in Texas — and they're designed to protect builders operating under Texas law.In this conversation, we cover:Why TAB contracts exist and how they differ from generic templatesCommon contract mistakes that expose builders to unnecessary legal riskHow properly structured agreements protect both builders and homeownersThe role contracts play in dispute prevention and risk managementWhy professional builders should treat contracts as a strategic tool — not just paperworkIf you're a custom home builder, remodeler, or residential contractor in Texas, this episode will help you better understand how to protect your business and operate more professionally.Contracts aren't just legal documents — they set expectations, define relationships, and can determine whether a project ends in success or in court.Listen in and learn why TAB contracts may be one of the most important investments you make in your business.

Today, I'm joined again by Laura Leigh Oyler, VP of Regulatory Affairs at HAYPP to talk about the latest going-ons in the world of tobacco and nicotine regulation in the US!For all the breaking snus news, newest reviews, and extensive information - http://www.Snubie.comSnubie Podcast - http://www.PouchCast.comSocial Media:Facebook - http://www.Facebook.com/SnubieInstagram - http://www.Instagram.com/SnubieDotComTwitter/X - http://www.X.com/SnubieDotComReddit - http://www.reddit.com/r/SnubieDotCom

From global trade shows to major tariff and trade developments, ABC's Global Technical and Regulatory Affairs team breaks down what matters most in highlights from their February Global Update. Tune in to this Almond Byte episode for key takeaways on international market access, evolving trade agreements, and why global engagement remains critical for U.S. almonds.

How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands.A few of Nelly's key takeaways:Resilience is adaptability—build organizations that absorb and anticipate change rather than resist itSeparate innovation from execution with intentional gates for when new approaches are ready to implementDocument your assumptions so you can revisit decisions effectively when circumstances changeFailure is a process problem, not a personal one—root cause analysis should improve systems, not assign blameData is the common language that aligns scientists, regulators, and stakeholdersEveryone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their handsAbout Nelly ViseuxNelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy.About The FDA GroupThe 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. Learn more: ⁠⁠https://www.thefdagroup.com/

Singapore has long been one of the world’s busiest aviation hubs — but a new challenge is taking off. Sustainable Aviation Fuel, or SAF, promises to cut the industry’s carbon footprint, but scaling it fast enough is no small feat. On Industry Insight, Lynlee Foo speaks to Steven Bartholomeusz, Head of Public & Regulatory Affairs, Asia Pacific, Neste to find out why early action on SAF isn’t just green — it’s smart business.See omnystudio.com/listener for privacy information.

Based on AHLA's annual Health Law Connections article, this special ten-part series brings together thought leaders from across the health law field to discuss the top ten issues of 2026. In the second episode, Zi Peng, Managing Director, StoneTurn, speaks with Alya Sulaiman, Chief Compliance and Privacy Officer & SVP of Regulatory Affairs, Datavant, about some of the primary issues around artificial intelligence (AI) in health care as organizations plan for 2026. They discuss the use of AI in prior authorization and utilization management, tensions between the federal government and the states over AI regulation, and actionable steps health care organizations should take to mitigate risk and ensure responsible AI deployment. Sponsored by StoneTurn.Watch this episode: https://www.youtube.com/watch?v=LCJ5w4CN-QoRead AHLA's Top Ten 2026 article: https://www.americanhealthlaw.org/content-library/connections-magazine/article/a879dda5-35f9-46fb-ad45-1b0799343d74/Health-Law-Forecast-2026Access all episodes in AHLA's Top Ten 2026 podcast series: https://www.americanhealthlaw.org/education-events/speaking-of-health-law-podcasts/top-ten-issues-in-health-law-podcast-seriesLearn more about StoneTurn: https://stoneturn.com/ Essential Legal Updates, Now in Audio AHLA's popular Health Law Daily email newsletter is now a daily podcast, exclusively for AHLA Comprehensive members. Get all your health law news from the major media outlets on this podcast! To subscribe and add this private podcast feed to your podcast app, go to americanhealthlaw.org/dailypodcast. Stay At the Forefront of Health Legal Education Learn more about AHLA and the educational resources available to the health law community at https://www.americanhealthlaw.org/.

In dieser Folge sprechen wir über ein Format, das die Medizintechnikbranche schon jetzt bewegt: die regularia – das neue Regulatorik-Forum für die Medizintechnik, das am 3. März 2026 erstmals in Tuttlingen stattfinden wird. Gastgeberin Julia Steckeler spricht mit dem Beiratsmitglied Dr. Corina Matzdorf über die Idee hinter dem Forum, echte Praxisnähe, die Auswahl der Fachbeiträge sowie den dringend notwendigen Dialog mit der Politik. Herausgekommen ist ein Gespräch voller Perspektiven, ehrlicher Einblicke und einer klaren Botschaft: Regulierung ist eine Gestaltungsaufgabe und funktioniert nur im Dialog.

Send us a textDr. Ellen de Brabander, Ph.D. is Executive Vice President, Research, Development and Regulatory Affairs at Elanco Animal Health ( https://www.elanco.com/us/leadership/executive-committee/ellen-de-brabander ), one of the world's largest animal pharmaceutical companys that develops, manufactures, and sells medicines, vaccines, and other health-care products for both pets (companion animals) and farm livestock (cattle, swine, poultry, etc.). Dr. de Brabander joined Elanco in October 2021 and is responsible for the global research and development organization and regulatory affairs. She is a highly experienced R&D leader with a proven background of accomplishments in animal health research and development.From March 2014 to October 2021, Dr. de Brabander served as Senior Vice President for Research and Development with PepsiCo, the global food and beverage company, most recently having company-wide responsibility for food safety, quality, regulatory and R&D digital transformation. Prior to PepsiCo, Dr. de Brabander led R&D organizations for Merial (now Boehringer Ingelheim Animal Health), Intervet (now Merck Animal Health) and DSM.Dr. de Brabander earned her doctorate (cum laude) in bio-organic chemistry from Leiden University in the Netherlands and completed her post-doctoral work in molecular biology at the Massachusetts Institute of Technology. She has lived in six different countries, is the co-author of more than 60 publications in scientific journals, holds 18 patents and has received multiple awards for her research, including the Golden Medal from the Royal Dutch Chemical Society in 2000 for Best Chemist Under 40.Important Episode Links -Investor Day Presentation - Defining Elanco's New Era of Growth - December 9, 2025https://s1.q4cdn.com/466533431/files/doc_events/2025/Dec/09/FINAL_ELAN-2025-Investor-Day-Presentation.pdf#EllenDeBrabander #ElancoAnimalHealth #Parasiticides #Therapeutics #Pharmaceuticals #Vaccines #PreventiveCare #Ruminants #Cattle #Swine #Poultry #Cats #Dogs #OneHealth #FutureProtein #Biologics #AdvancedTherapeutics #MonoclonalAntibodies #Zenrelia #CredelioQuattro #IntestinalIntegrity #Microbiome #Bovaer #MethaneReduction #CattleEmissions #AntimicrobialResistance #ChronicKidneyDisease #AtopicDermatitis #STEM #Innovation #Science #Technology #Research #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #Podcasting #ViralPodcastSupport the show

The past few years have been a critical time in the development of data privacy laws and the regulation of AI in the United States. As we look toward 2026, the complexities are only increasing. In this episode, the Antitrust Law Section's Privacy and Information Security (PRIS) Committee joins forces with OCA to focus on the highlights of 2025 and predictions for 2026. Hosts Alicia Downey and Anora Wang talk to PRIS Committee vice chairs Jessica Cohen of Verizon Communications and Alex Brown of Alston & Bird about why the next 12 months could redefine how AI and data privacy are regulated at the federal and state levels. In addition, listeners will hear from Jessica about being a mother of five, and get an update on Walter, a beauty pageant-winning dog, who was just a puppy when Alex was a featured guest on OCA Episode #89 back in 2020. With special guests: Jessica Cohen, Senior Counsel, Regulatory Affairs, AI, Cybersecurity & Privacy, Verizon Communications and Alexander G. Brown, Partner, Alston & Bird LLP Related Links: Kathleen Benway, Alexander G. Brown, Maki DePalo, Jennifer C. Everett, Graham Gardner & Hyun Jai Oh, "Flurry of FTC Activity Shows Enforcement Emphasis on Youth Protection," 12 PRATT'S PRIVACY &CYBERSECURITY LAW REPORT 8 (LexisNexis A.S. Pratt 2026) Alexander G. Brown & Katherine Doty Hanniford, "First 100 Days – Federal Privacy and Cybersecurity Regulation and Enforcement Under the Second Trump Administration," Alston & Bird Advisory (May 8, 2025) Our Curious Amalgam, Episode #89 What's the Deal with Data Portability? Understanding the Competition and Privacy Aspects Surrounding the Movement of Data, November 30, 2020, featuring Alex Brown Hosted by: Alicia Downey, Downey Law and Anora Wang, Arnold & Porter

In this episode of Product & Packaging Powerhouse, Megan Young Gamble talks with regulatory specialist Mo Lovelace , co-CEO of Steinberg & Associates, about the evolving landscape of cosmetic product regulations. They discuss the impact of the Modernization of Cosmetics Regulation Act (MOCRA), which now mandates FDA registration for both products and manufacturing facilities, no matter the brand size. Mo Lovelace breaks down responsibilities brands have for reporting adverse events, labeling compliance, and the significance of ingredient bans at both federal and state levels (especially California's new requirements). The conversation emphasizes the importance of regulatory specialists in product development, best practices around documentation, and how brands, big or small, should prioritize compliance to prevent costly mistakes. Plus, there's practical advice on substantiating marketing claims and tips for surviving regulatory changes in 2026. The episode wraps with a fun rapid-fire round exploring Mo Lovelace's passion for tennis and family life.Affiliate & Other Links:[Megan Young Gamble Links][AFFILIATE] Ready to crank out your content in as little as 5 minutes? Use Castmagic, AI powered tool to take your content creation from overwhelmed to overjoyed by saving hours of developing content. Save 20 hours by Signing up today! https://get.castmagic.io/Megan [FREEBIE] Learn about “day in the life” of a Packaging Project Manager → Get our “Starter Packaging PM Freebie” [link] https://glc.ck.page/thestarterpackagingprojectmanager [FREEBIE] Access commonly referenced organizations and tools in ONE PLACE with our handy guide HERE [link] https://bit.ly/OSTPlay Subscribe & Access our Video Vault YouTube Channel [ link] https://bit.ly/GLConYouTubeJoin our Email List [link] https://glc.ck.page/55128ae04b Follow and Connect with Megan on LinkedIn [link] https://linkedin.com/in/megangambleLearn about GLC, Packaging & Project execution firm for CPG brands http://www.getlevelconsulting.comWork with Me @ GLC, Schedule Discovery Call https://calendly.com/getlevelconsulting/15-minute-insight-sessionGot a topic you'd love us to cover? Share your ideas here [link] https://bit.ly/ppptopicform[Powerhouse Guest Mo's LINKS]LinkedIn: https://www.linkedin.com/in/moyin-lovelace-2743a792/Company Website : https://www.steinbergandassociates.comEmail Address:  mo@steinbergandassociates.comAdditional Resource links: Sustainable Packaging Coalition: https://sustainablepackaging.org/Circular Action Alliance: https://circularactionalliance.org/Independent Beauty Association (IBA): https://independentbeauty.org/ Quotes:An ounce of prevention will save you a whole lot of money at the other end.From the FDA and FTC standpoint, your claims should always be truthful and not misleading.I don't want my brands to launch products out here and they're not compliant.Clean does not mean safeYou should be starting now, because as your brand grows, you already understand what compliance looks like.Conquer the US first, build your business here, and then look into going elsewhere.The stronger your claims are, the stronger your data to support that claim should be.

Please enjoy this encore of Career Notes. Lauren Van Wazer, Vice President, Global Public Policy and Regulatory Affairs for Akamai Technologies, shares her story as she followed her own North Star and landed where she is today. She describes her career path, highlighting how she went from working at AT&T to being able to work in the White House. She shares how she is a coach and a leader to the team she works with now, saying "my view is I've got their back, if they make a mistake, it's my mistake, and if they do well, they've done well." Lauren hopes she's made an impact in the world by making it a little bit better than before, and discusses how she doesn't let anyone stop her from her goals. Lauren shares her outlook on her experiences, calling attention to different roles in her life that made her journey all the better. We thank Lauren for sharing. Learn more about your ad choices. Visit megaphone.fm/adchoices

Please enjoy this encore of Career Notes. Lauren Van Wazer, Vice President, Global Public Policy and Regulatory Affairs for Akamai Technologies, shares her story as she followed her own North Star and landed where she is today. She describes her career path, highlighting how she went from working at AT&T to being able to work in the White House. She shares how she is a coach and a leader to the team she works with now, saying "my view is I've got their back, if they make a mistake, it's my mistake, and if they do well, they've done well." Lauren hopes she's made an impact in the world by making it a little bit better than before, and discusses how she doesn't let anyone stop her from her goals. Lauren shares her outlook on her experiences, calling attention to different roles in her life that made her journey all the better. We thank Lauren for sharing. Learn more about your ad choices. Visit megaphone.fm/adchoices

Bongani Bingwa speaks with Johnny Moloto, Head of Corporate and Regulatory Affairs at BAT Sub-Saharan Africa, about the company’s decision to exit local manufacturing in South Africa. 702 Breakfast with Bongani Bingwa is broadcast on 702, a Johannesburg based talk radio station. Bongani makes sense of the news, interviews the key newsmakers of the day, and holds those in power to account on your behalf. The team bring you all you need to know to start your day Thank you for listening to a podcast from 702 Breakfast with Bongani Bingwa Listen live on Primedia+ weekdays from 06:00 and 09:00 (SA Time) to Breakfast with Bongani Bingwa broadcast on 702: https://buff.ly/gk3y0Kj For more from the show go to https://buff.ly/36edSLV or find all the catch-up podcasts here https://buff.ly/zEcM35T Subscribe to the 702 Daily and Weekly Newsletters https://buff.ly/v5mfetc Follow us on social media: 702 on Facebook: https://www.facebook.com/TalkRadio702 702 on TikTok: https://www.tiktok.com/@talkradio702 702 on Instagram: https://www.instagram.com/talkradio702/ 702 on X: https://x.com/Radio702 702 on YouTube: https://www.youtube.com/@radio702See omnystudio.com/listener for privacy information.

Allegations of politically motivated “debanking” have intensified debate over how federal regulation, supervisory practices, and concerns about “reputation risk” influence banks’ decisions about which customers to serve. In recent months, the President issued an Executive Order directing agencies to reexamine supervisory and risk-management frameworks, while the banking regulators themselves have taken steps related to supervision, anti-money-laundering obligations, and the treatment of reputation risk—often implicating questions surrounding confidential supervisory information. At the same time, Congress and stakeholders across the financial sector continue to grapple with the scope and meaning of federal “fair access” standards and what they might require of banks going forward.With these developments unfolding in parallel, important questions remain unresolved. What role should the government play in shaping banks’ customer relationships? How should supervisory expectations be calibrated, and what legal clarity—whether legislative or regulatory—might be needed to strike the proper balance?Please join the Federalist Society on Wednesday, January 7, at 12 PM ET for a virtual discussion exploring these issues and examining where regulators and lawmakers may go from here. Featuring: John Berlau, Senior fellow and Director of Finance Policy, Competitive Enterprise InstituteTabitha Edgens, Executive Vice President & Co-Head of Regulatory Affairs, Bank Policy InstituteBrian Knight, Senior Counsel, Corporate Engagement Team, Alliance Defending Freedom(Moderator) John Heltman, Washington Bureau Chief, American Banker

In this episode, Diana O'Lare sits down with Phil Crone, Vice President of State and Regulatory Affairs at Leading Builders of America, for an in-depth conversation on the U.S. housing affordability crisis—and what political and regulatory hurdles exist. Together, they unpack the real-world challenges driving up costs and limiting supply, including permitting delays and the need for reform, the growing burden of regulatory and compliance costs, and how factors like institutional buyers and workforce shortages are reshaping the housing market. They also explore the evolving role of energy efficiency requirements, as well as the design, infrastructure, and construction innovations that could help accelerate production and expand access to more attainable homes. Tune in for a thoughtful discussion on the policies and solutions that can help make housing more affordable for more Americans.

In this episode, James talks with Craig Gordon, Head of Global Policy, Regulatory Affairs, and Business Development at Mainspring Energy. Craig brings deep experience in clean energy—from scaling Invenergy's wind and solar projects to shaping U.S. energy policy with the American Clean Power Association. Today, he's helping Mainspring redefine dispatchable generation for a rapidly electrifying world.They discuss how Mainspring's linear generator technology offers a modular, dispatchable solution ideal for the growing energy demands of hyperscale data centers. Craig shares insights on the importance of fuel flexibility, how the Inflation Reduction Act has reshaped deployment dynamics, and the policy shifts enabling faster, cleaner energy integration behind the meter.How Mainspring's linear generator bridges the gap between renewables and dispatchable generationThe role of fuel-flexibility (natural gas, hydrogen, ammonia) in enabling resilient sitingWhy data center load growth is stressing legacy regulatory frameworksHow recent FERC policy shifts are opening new doors for behind-the-meter innovationA must-listen for developers navigating grid constraints, data center energy needs, and next-gen dispatchable tech.Paces helps developers find and evaluate the sites most suitable for renewable development. Interested in a call with James, CEO @ Paces?

Welcome to Season 3 of ANCOR Links!There's a lot of talk about Medicaid these days, so we decided to resurrect the premise of a quirky show, and bust some Medicaid myths!Donna Martin, VP of State Partnerships & Innovation, and Tom Rice, Director of Policy & Regulatory Affairs, sat down with Tricia DePalatis, Membership Coordinator, to discuss ten myths about the Medicaid program. Join us as we dive deep into one of the federal government's most misunderstood programs.=================This podcast is produced by ANCOR, the leading voice in Washington, DC, for providers of services for people with disabilities. Views expressed during the podcast do not necessarily reflect the position of ANCOR.To learn more, visit ⁠⁠⁠⁠⁠⁠ancor.org⁠⁠⁠⁠⁠⁠.=================Intro and outro music provided by YouTube Audio Library Intro Music ⓒ V for Victory - Audionautix Outro Music ⓒ Dirt Rhodes - Kevin MacLeod

The FDA's transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant update to 21 CFR Part 820 in nearly two decades. But for medical device manufacturers, this is more than just a regulatory rewrite—it is a shift toward global harmonization that requires immediate strategic action.In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo, Senior Director of Quality at Kymanox, to unpack the practical realities of the QMSR rollout. With over 30 years of experience in quality systems and design controls, David explains why "being ISO 1345 certified" isn't a free pass for compliance and how to turn this regulatory hurdle into a long-term business advantage.Topics Include:The "Why" Behind QMSR: Understanding the FDA's push to harmonize with ISO 1345:2016 and what it means for global market access.Risk Management Evolution: Moving beyond product risk (ISO 14971) to apply risk-based decision-making across the entire quality system, from CAPAs to training.The Certification Myth: Why your existing ISO 1345 certificate won't stop the FDA from auditing your facility.Supplier Controls: How to update supplier files to be "living documents" that satisfy the new monitoring requirements.A 5-Step Implementation Roadmap: A proven strategy to assess gaps, remediate SOPs, and ensure your team is ready before the deadline.Whether you are a VP of Quality or a Regulatory Affairs specialist, this conversation offers a clear, science-forward path to navigating the new landscape of medtech compliance.

The Centers for Medicare and Medicaid Services has finalized the 2026 Outpatient Perspective Payment System (OPPS) rule, with most policies taking effect on January 1, 2026. Jenna Stern, Vice President of Regulatory Affairs and Public Policy at Vizient, joins host Carolyn Liptak, Pharmacy Executive Director in Vizient's Center for Pharmacy Practice Excellence, to discuss key updates to payment policies, payment rates, and quality provisions affecting Medicare beneficiaries receiving care in hospital outpatient departments and ambulatory surgical centers.   Guest speaker:    Jenna Stern Vice President of Regulatory Affairs and Public Policy Vizient Host:   Carolyn Liptak, MBA, RPh  Pharmacy Executive Director Vizient  Verified Rx Host   Show Notes: 00:05 — Introduction Announcer welcomes listeners to VerifiedRx. Host Carolyn Liptak, Pharmacy Executive Director at Vizient, introduces the episode focus: the 2026 CMS Outpatient Prospective Payment System (OPPS) Final Rule. Guest: Jenna Stern, VP of Regulatory Affairs and Public Policy at Vizient.   01:12 — Overview of the OPPS Final Rule OPPS sets Medicare payment for most hospital outpatient services. Published annually (typically November), effective January 1. Covers payment rates, policies, quality programs, and compliance requirements. Note: CMS delayed enforcement of hospital price transparency requirements until April 1, 2026.   01:34 — Key Takeaways From the 2026 Final Rule Jenna's high-level insights: Hospitals will continue facing financial pressure in 2026. Modest payment rate increase combined with reimbursement-reducing policies. Expansion of site-neutral payment policies will be particularly impactful. Rule reflects emerging administration priorities shaping future policy.   02:21 — OPPS Payment Rate Update for 2026 CMS finalized a 2.6% OPPS schedule increase factor for hospitals meeting quality reporting requirements.   02:40 — What the 2.6% Increase means Based on: 3% market basket update –0.7% productivity adjustment Results in a modest net increase. Slightly better than the proposed 2.4% increase, though still viewed as inadequate. CMS estimates $8 billion increase in total OPPS payments compared to 2025.   03:37 — 340B Remedy Offset: Background From 2018–2022, CMS paid for 340B drugs at ASP –22.5%. Prior Supreme Court decision from 2022 found that CMS lacked authority to vary rates as finalized in prior rulemaking (e.g., without using drug acquisition cost surveys to inform policy).   04:13 — 340B Remedy Offset in the 2026 Final Rule CMS considered increasing the remedy offset from 0.5% to 2%. Stakeholders strongly opposed the increase due to hospital financial strain.   05:10 — Final Outcome CMS retained the 0.5% offset for 2026. CMS signaled that larger offsets may be proposed for 2027. This marks the first year the remedy offset takes effect,   06:00 — Site-Neutral Payment Policy: What It Is Concept: same service = same payment, regardless of site of care. Hospital concern: policy reduces hospital reimbursement without accounting for site of care differences, patient acuity, overhead, or service complexity.   06:15 — Site-Neutral Expansion in the 2026 Rule CMS expanded site-neutral payment to include drug administration services at excepted off-campus provider-based departments.   07:08 — Financial Impact Reimbursement aligns with Physician Fee Schedule rates. CMS estimates $290 million reduction in outpatient spending for 2026. $220 million of savings accrue directly to Medicare. Not implemented in a budget-neutral manner.   08:14 — Non-Opioid Pain Management Payments Temporary additional payments began January 1, 2025. Authorized under the NO PAIN Act (Consolidated Appropriations Act of 2023).   08:28 — What's New for 2026 CMS finalized the renewal of: 5 drugs 13 medical devices eligible for separate payment in HOPD and ASC settings. Per statue, payments available through December 31, 2027.   09:32 — Process Improvements CMS will allow more frequent consideration of new qualifying products (not limited to annual updates). Quality criteria unchanged; timing flexibility added. CMS released guidance on how stakeholders can engage for inclusion.   10:58 — OPPS Drug Acquisition Cost Survey CMS finalized plans to survey hospitals on acquisition costs for separately payable OPPS drugs.   11:21 — Why CMS Is Advancing the Survey Addresses Supreme Court requirements from prior 340B litigation. Aligns with White House Executive Order on lowering drug prices. Positions CMS to use survey data for 2027 rulemaking.   12:47 — OPPS Packaging Thresholds for 2026 Drugs and biologics: Threshold remains at $140. Diagnostic radiopharmaceuticals: Increased to $655 (from $630). Products below thresholds retain Status Indicator “N” (packaged payment).   13:26 — Why Billing Packaged Drugs Still Matters Even though not separately payable, hospitals must bill for packaged drugs. Billing data feeds cost reports used to calculate future bundled payments. Failure to bill can result in inaccurately low reimbursement.   14:14 — Elimination of the Inpatient-Only (IPO) List CMS finalized a three-year transition to eliminate the IPO list by January 1, 2029.   14:32 — Why This Change Is Significant IPO list historically ensured certain services were provided inpatient only. CMS emphasizes provider judgment in determining site of care. Raises concerns about: Patient safety Payer coverage changes Pressure to move services outpatient   16:28 — ASC Covered Procedure List Expansion CMS expanded the ASC Covered Procedure List. Enables more Medicare covered services to be performed in the ASC settings.   16:48 — Price Transparency: Still a Priority No major overhaul, but continued refinement. CMS exploring new uses of price transparency data beyond patient comparison.   17:46 — Most Critical Policies to Watch Jenna highlights: Modest OPPS payment increase Site-neutral payment expansion 340B remedy offset Drug acquisition cost survey Broader regulatory activity beyond OPPS   18:43 — Available Vizient Resources OPPS Final Rule Summary Government Relations & Public Policy Summaries  Advocacy   19:20 — Closing Carolyn thanks Jenna for her insights. Reminder to subscribe, like, and share feedback. VerifiedRx is produced by the Vizient Center for Pharmacy Practice Excellence.   Links | Resources:  Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots: Click Here CMS fact sheet on the Final Rule: Click Here Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey: Click Here Vizient Office of Public Policy and Government Relations final rule summary:  Click Here Final List of Qualifying Products for Separate Payment for non-opioid pain medications: (Table 136, pgs. 1138-1140)   VerifiedRx Listener Feedback Survey: We would love to hear from you - Please click here   Subscribe Today! Apple Podcasts Spotify YouTube RSS Feed    

My guest today is Cass R. Sunstein, University Professor at Harvard and one of the most influential legal and political thinkers of our time. A prolific author of dozens of books and hundreds of academic articles, Cass has shaped debates in constitutional law, administrative law, behavioral economics, and public policy. He is regularly ranked amongst the very top of the most cited legal scholars alive. Cass also served as Administrator of the White House Office of Information and Regulatory Affairs under President Obama. He has advised governments and international organizations around the world, and was awarded the Holberg Prize, the equivalent of a Nobel in law and the humanities.His latest book, On Liberalism: In Defense of Freedom, is a systematic defense of the liberal tradition at a moment when it is, as he shows, under unprecedented pressure. Our conversation is centered around his book. We begin with the urgency at the heart of the book: how liberalism confronts critiques from moral conservatives and egalitarian progressives alike, what it means to defend the liberal framework in an era of fragmentation, etc. We then turn to questions of scaling: does liberalism have internal patterns or institutional mechanisms that allow it to scale across diverse societies. We grapple with how the liberal tradition's “big tent” of thinkers (from Mill and Hayek to Roosevelt's Second Bill of Rights) impact liberalism ability to scale. We also explore how liberalism navigates technological change, expertise versus public accountability, and the pretence of knowledge. I hope you enjoy our discussion.You can follow me on X (@⁠⁠ProfSchrepel⁠⁠) and BlueSky (@⁠⁠ProfSchrepel⁠⁠).**References:On Liberalism (MIT Press, 2025) https://mitpress.mit.edu/9780262049771/on-liberalism/

Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum.In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later.Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable.A few key takeaways:Early quality work should be right-sized, not commercialized prematurelyDesign space, material variability, and sensitivities must be understood and documented earlyFMEA works best when it evolves with the product—not when it's treated as a one-time exerciseFDA and EU requirements can diverge in ways that materially affect submission timingClear documentation and regular, direct communication prevent avoidable delaysJackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical, a fully integrated CDMO with decades of experience supporting pharmaceutical drug products, medical devices, biologics, and APIs. She has led quality systems and development programs across multiple global manufacturing sites and brings deep expertise in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, validation, risk management, and cross-functional leadership.About The FDA GroupThe 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. Learn more: ⁠⁠https://www.thefdagroup.com/

Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams.In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better.Throughout the discussion, we cover:A clear, simple explanation of Verification vs. ValidationWhy V&V must span the entire development lifecycleHow poor requirements create downstream V&V failuresThe risks of starting V&V planning too lateHow to simplify test methods without losing rigorPractical strategies for handling failed testsHow to think about traceability without fearThe future of V&V as software and AI become more prevalentThis episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes.Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Social Media to follow Aaron Joseph Linkedin: https://www.linkedin.com/in/ajosephprofile/Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

The FDA Group's Nick Capman sits down with Mike Martin, President and CEO of ISPE, for a conversation on how the pharmaceutical industry must rethink workforce development amid rapid technological and cultural change.Drawing on nearly four decades of global experience in pharmaceutical engineering, operations, and manufacturing leadership, Mike shares his perspective on why the industry is entering a new industrial era — often referred to as Pharma 4.0 — and what that means for engineers, operators, and leaders at every level.The discussion explores how automation, robotics, and AI are reshaping day-to-day work, why deep technical expertise remains critical in an AI-driven environment, and how organizations must move beyond reactive reskilling toward more intentional “pre-skilling” of future talent. Mike also reflects on the enduring importance of character, integrity, curiosity, and trust, arguing that these traits matter as much as technical competence in a highly regulated industry.Nick and Mike examine the evolving role of professional organizations like ISPE in building global communities of practice, sharing knowledge across borders, and supporting lifelong learning. The conversation also addresses how learning itself is changing — from long-form training to bite-sized, modular education — and what leaders must do to engage a new generation of professionals with different expectations around purpose, speed, and technology.Throughout the episode, Mike emphasizes a unifying theme: innovation and compliance are not opposing forces. When approached correctly, innovation strengthens quality, improves compliance, and ultimately enhances patient safety.This episode is a must-listen for anyone responsible for building teams, modernizing operations, or preparing their organization for the future of pharmaceutical manufacturing and engineering.About The FDA GroupThe 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. Learn more: ⁠https://www.thefdagroup.com/

As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026.The episode reflects on a full year of continuous content creation, including:Weekly podcast episodes covering global medical device regulationsIncreased focus on artificial intelligence and its impact on QA/RA rolesEducational initiatives such as EMD Mag, designed to make complex regulatory topics more accessibleDevelopment of digital tools like EasyIFU, labeling automation, and eQMS solutionsExpansion of consulting, back-office services, and international presenceThe discussion also addresses upcoming challenges:Increasing pressure on Notified BodiesRisks for late MDR/IVDR transitionsThe importance of anticipation and regulatory strategy for new and existing manufacturersMore than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment.Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.The discussion covers:Key shortcomings of the current MDR/IVDR frameworkThe impact on innovation, availability of devices, and SMEsThe eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified BodiesHow upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulationsThis episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.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  Adam Linkedin: https://www.linkedin.com/in/adam-isaacs-rae/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 

Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in this field?In this episode of the Medical Device Made Easy podcast, Monir El Azzouzi interviews Florian Tolkmitt, Clinical Evaluation Expert at Pro-Liance, to explore his journey from engineering into clinical evaluation and regulatory science.The discussion covers:Florian's education and early career pathHow he specialized in Clinical EvaluationKey lessons learned since the implementation of the EU MDRWhat Notified Bodies really expect from clinical documentationFrequent mistakes manufacturers make in clinical submissionsThe evolving role of consultants in supporting complianceHow AI and digital tools may transform literature review and evidence generationAdvice for young professionals entering the MedTech fieldThis episode offers practical insights, career inspiration, and forward-looking perspectives for anyone working — or aspiring to work — in clinical evaluation and regulatory affairs.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.LinksLinkedin florian: https://www.linkedin.com/in/florian-tolkmitt-clinical-evaluation/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

Ever worry about finding yourself in a civil or criminal case as a result of your actions as a nurse?  Join the co-hosts as they welcome Attorney Rachel Giles to help us demystify nursing legal liability, including must-dos, don't-dos, and real-world pitfalls so you can protect your license, your patients, and your peace of mind. (AMSN Members Earn 0.5 CE Hours*) * This episode is eligible for 0.5 contact hours for AMSN members who listen to the episode and submit a completed evaluation through the online library. None of the individuals with the ability to control the content of this episode have any relevant financial relationships with ineligible companies to disclose. The Academy of Medical Surgical Nurses is an accredited provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation.   SPECIAL GUEST Rachel Giles, JD, MBA/MHA is a United States Army Veteran, brings over a decade of experience in health law, compliance, federal regulations, and risk management. She is dedicated to delivering innovative conflict resolution, consulting, education, and knowledge, leveraging her unique expertise to help clients and healthcare organizations navigate complex challenges in both legal and operational environments. Rachel is passionate about fostering effective communication and equitable solutions to ensure that every person feels safe and empowered to move forward confidently. Rachel's professional experience includes serving as CEO of Giles Mediation, LLC., where she assist low socioeconomic status clients mediate cases in an attempt to stay out of a long costly court battle. She was the Vice President of Compliance & Administration for AshtonBridge Capital, where she implemented risk management frameworks and compliance protocols across diverse industries such as investment, real estate, and commodity trading. Additionally, her tenure in senior roles at multiple Healthcare Organizations within the Texas Medical Center in Houston highlights her skill in mitigating risks, conducting audits, and driving quality and patient safety improvement initiatives. She is adept at contract negotiation, policy development, and litigation support, making her a trusted advisor to organizations. Academically, Rachel holds a Doctorate in Law with a specialization in Compliance, Regulatory Affairs, and Risk Management, alongside dual master's degrees in Business and Health Administration. Her credentials are complemented by certifications in Lean Six Sigma, Project Management, and Mediation. She was recognized for academic excellence, including achieving top marks in cybersecurity coursework, where she developed actionable strategies for addressing HIPAA data breaches. Her ability to merge research with practical application has been a hallmark of her professional and academic career.   MEET OUR CO-HOSTS Samantha Bayne, MSN, RN, CMSRN, NPD-BC is a nursing professional development practitioner in the inland northwest specializing in medical-surgical nursing. The first four years of her practice were spent bedside on a busy ortho/neuro unit where she found her passion for newly graduated RNs, interdisciplinary collaboration, and professional governance. Sam is an unwavering advocate for medical-surgical nursing as a specialty and enjoys helping nurses prepare for specialty certification.    Kellye' McRae, MSN-Ed, RN is a dedicated Med-Surg Staff Nurse and Unit Based Educator based in South Georgia, with 12 years of invaluable nursing experience. She is passionate about mentoring new nurses, sharing her clinical wisdom to empower the next generation of nurses. Kellye' excels in bedside teaching, blending hands-on training with compassionate patient care to ensure both nurses and patients thrive. Her commitment to education and excellence makes her a cornerstone of her healthcare team.   Marcela Salcedo, RN, BSN is a Floatpool nightshift nurse in the Chicagoland area, specializing in step-down and medical-surgical care. A member of AMSN and the Hektoen Nurses, she combines her passion for nursing with the healing power of the arts and humanities. As a mother of four, Marcela is reigniting her passion for nursing by embracing the chaos of caregiving, fostering personal growth, and building meaningful connections that inspire her work.   Eric Torres, ADN, RN, CMSRN is a California native that has always dreamed of seeing the World, and when that didn't work out, he set his sights on nursing.  Eric is beyond excited to be joining the AMSN podcast and having a chance to share his stories and experiences of being a bedside medical-surgical nurse.   Maritess M. Quinto, DNP, RN, NPD-BC, CMSRN is a clinical educator currently leading a team of educators who is passionately helping healthcare colleagues, especially newly graduate nurses. She was born and raised in the Philippines and immigrated to the United States with her family in Florida. Her family of seven (three girls and two boys with her husband who is also a Registered Nurse) loves to travel, especially to Disney World. She loves to share her experiences about parenting, travelling, and, of course, nursing!   Sydney Wall, RN, BSN, CMSRN has been a med surg nurse for 5 years. After graduating from the University of Rhode Island in 2019, Sydney commissioned into the Navy and began her nursing career working on a cardiac/telemetry unit in Bethesda, Maryland.  Currently she is stationed overseas, providing care for service members and their families.  During her free time, she enjoys martial arts and traveling. 

The FDA Group's Nick Capman sits down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality-centric culture that drives compliance, operational excellence, and long-term resilience in the biopharmaceutical industry. A microbiologist by training with more than 35 years of BioPharma leadership experience, Chris has led global quality organizations at Ipsen, Cubist (Merck), and now Tolmar, as well as his own consultancy. Across the U.S., Europe, and Asia, he has managed large CMO networks, established inspection-readiness programs, and led cultural change within complex, matrixed organizations.Nick and Chris explore what truly defines a quality-centric culture, how leadership and accountability shape it, and the practical, long-term steps required to sustain it.In this conversation, Chris shares insights on:What “quality culture” really means—and how to make it visible at every level of an organization.The leadership behaviors that create alignment and consistency across global teams.How to embed compliance and continuous improvement into daily operations.Managing uncertainty, pressure, and change without losing focus on the patient.Practical methods for measuring and improving quality culture over time.Why humility and transparency are non-negotiable for sustainable performance.About The FDA GroupThe 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. Learn more: https://www.thefdagroup.com/

In this episode, Stephanie Batliner, VP of Regulatory Affairs and R&D North America for Bimeda, joined us to discuss the FDA approval process for pioneer and generic animal drugs. She also discussed veterinary devices, pharmacy compounding, counterfeit drugs, and more. This episode of Disease Du Jour is brought to you by Bimeda.GUESTS AND LINKS - EPISODE 171Host: Carly Sisson (Digital Content Manager) of EquiManagement | Email Carly (CSisson@equinenetwork.com)Guest: Stephanie Batliner, VP of Regulatory Affairs and R&D North America for BimedaPodcast Website: Disease Du JourThis episode of Disease Du Jour podcast is brought to you by Bimeda.Connect with the Host: Carly Sisson (Digital Content Manager) of EquiManagement | Email Carly (CSisson@equinenetwork.com)

In this special episode of Aerospace Unplugged, our host Adam Kress reports on location from the inaugural American Aviation Leadership Summit hosted by Honeywell Aerospace in Washington, D.C.The event gathered hundreds of aviation professionals, including regulators and lawmakers, for a series of panels that cover what's needed to ensure America remains the global leader in aviation.Throughout the day, discussions focused on major industry topics such as safety, smarter airspace management, innovation, and more—all of which are spotlighted in this episode.  Episode Highlights:Modernization as the Cornerstone of American Aviation: Explore how lawmakers and industry leaders emphasized the urgent need to modernize aviation infrastructure and airspace, highlighting government and industry collaboration as essential for progress.Integrating New Technologies for Safety and Efficiency: Understand the critical role of airspace integration and air traffic control modernization, as discussed by expert panels, in ensuring safety and operational efficiency as advanced technologies enter the market.Advancing Public Acceptance and State-Level Innovation: Learn how state initiatives, such as those in Florida, are driving modernization in advanced air mobility, drones, and ATC systems, with a focus on public acceptance and regulatory adaptation.Regulatory Pathways and the Future of Aviation Autonomy: Dive into the evolving landscape of aviation certification, autonomy, and artificial intelligence, including insights from industry CEOs and policymakers on the regulatory needs and future trends shaping national airspace and safety.Here insights from: James Currier, President and CEO, Honeywell Aerospace; Sean Duffy, U.S. Secretary of Transportation; Chairman Troy Nehls (R-TX), U.S. House Transportation Committee, Aviation Subcommittee; Rep. Sharice Davids (D-KS), U.S. House Transportation Committee, Aviation Subcommittee; Sharon Pinkerton, Senior Vice President, Legislative & Regulatory Policy, Airlines 4 America (A4A); Brandon Lint, Regulatory Affairs and Certification Specialist, Skygrid; David Murphy, Chief Architect and Product Manager, ANRA Technologies; Kevin Cox, CEO, Atlantic Vertiports; Justin Barkowski, Legislative and Regulatory Counsel, American Association of Airport Executives (AAAE); Clint Harper, Advanced Air Mobility Community Advocate; Jared Perdue, Secretary of Transportation, Florida Department of Transportation; Todd Sigler, Senior Director, Global Safety & Regulatory Affairs, Boeing; Eric Holmberg, Chief Developmental Test Pilot, Gulfstream; Captain Steve Jangelis, Air Safety Chair, Air Line Pilots Association (ALPA); Bryan Bedford, Administrator, Federal Aviation Administration (FAA); Cindy Comer, Vice President, SMS, Certification & Quality, Wisk; Scott O'Brien, Vice President, Legislative Affairs, Reliable Robotics; Dómhnal Slattery, Chairman of the Board, Vertical Aerospace; Eloa Guillotin, Co-Founder & CEO, Beyond Aero; Marc Allen, CEO, Electra; Rep. Jay Obernolte (R-CA), Co-Chair, Artificial Intelligence Task Force, U.S. House of Representatives.

In this insightful episode of the Women in AAM podcast, host Marilyn Pearson sits down with Amber Harrison, Director of Regulatory Affairs at Vertical Aviation International and a commercially rated helicopter pilot. With her unique blend of legal, operational, and aviation experience, Amber brings clarity to one of the most consequential regulatory developments affecting the future of drones and advanced air mobility (AAM): the FAA's proposed Part 108 rule. Amber breaks down why Part 108 represents a major shift for beyond visual line-of-sight (BVLOS) operations and how it will shape the integration of unmanned systems into low-altitude airspace. She explains the proposed framework for aircraft acceptance, maintenance, controller training, and third-party UTM oversight—highlighting how Part 108 moves the industry closer to scalable, autonomous operations. One of the most talked-about elements, Amber notes, is the proposed right-of-way hierarchy, which for the first time suggests unmanned aircraft may have priority over crewed aircraft under certain conditions. She explores why this creates operational complexity for pilots, regulators, and manufacturers—especially when population density maps, equipage requirements, and ADS-B/EC technology limitations are factored in. The discussion also dives into grey areas between drones and autonomous aircraft, raising essential questions about certification weight limits, governance, and future rulemaking for autonomy. Amber shares how VAI is advocating for a phased, safety-driven approach that acknowledges current technology gaps while supporting industry growth.

Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.In this podcast episode, we explore:

In this episode, Stephanie Batliner, VP of Regulatory Affairs and R&D North America for Bimeda, joined us to discuss the FDA approval process for pioneer and generic animal drugs. She also discussed veterinary devices, pharmacy compounding, counterfeit drugs, and more. This episode of Disease Du Jour is brought to you by Bimeda.GUESTS AND LINKS - EPISODE 171Host: Carly Sisson (Digital Content Manager) of EquiManagement | Email Carly (CSisson@equinenetwork.com)Guest: Stephanie Batliner, VP of Regulatory Affairs and R&D North America for BimedaPodcast Website: Disease Du JourThis episode of Disease Du Jour podcast is brought to you by Bimeda.Connect with the Host: Carly Sisson (Digital Content Manager) of EquiManagement | Email Carly (CSisson@equinenetwork.com)

The FDA Group's Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led global regulatory strategy for small- and large-molecule programs from Phase 1 through launch. He has prepared IND/IMPD/CTA/CTR/BLA/MAA submissions across multiple regions, secured expedited designations, managed FDA and ex-US health authority meetings, and built RA/QA systems for growing biotech organizations.Carlos shares practical, experience-tested guidance on how small and mid-size biotech companies can build regulatory resilience: strengthening governance, preparing for FDA interactions, improving documentation discipline, and integrating external partners without losing control. He also breaks down how to evaluate vendors, structure joint governance, embed QA into outsourced workflows, and design audit-ready data flows that prevent institutional knowledge loss.Topics discussed include:Why early regulatory infrastructure prevents costly reworkLeadership behaviors that shape regulatory cultureHow to prepare for high-stakes FDA and ex-US health authority meetingsThe risks of “tribal knowledge” in fast-moving organizationsA structured model for evaluating and managing external partnersHow small companies can stay inspection-ready with lean teamsOne takeaway: External partners can be force multipliers or liabilities—the sponsor's structure and oversight determine which.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 specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.https://www.thefdagroup.com/

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram and the episode's focus[00:05:15] Discussion on the challenges and opportunities of new regulations[00:10:40] Insights into the importance of confidence and adaptability in the regulatory field[00:15:20] Kavetha's journey and advice for emerging professionals[00:25:00] The role of innovation and collaboration in MedTech advancements[00:35:10] Strategies for professionals to stay relevant and proactiveQuotes:"Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram"Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols"Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha RamKey Takeaways:Insights into MedTech Trends:Regulatory changes are both a challenge and an opportunity for innovation.Practical Tips for MedTech Enthusiasts:Stay updated with regulatory changes and understand their implications.Engage in continuous learning and skill development.Foster collaboration across disciplines to enhance innovation.References:Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight GuruQuestions for the Audience:"What advice do you have for budding Regulatory Affairs professionals?"Reach out to us and let us know what you thought of the episode at podcast@greenlight.guruAlso, if you enjoyed this episode, please leave us a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Greenlight Guru's platform streamlines product development and compliance, making the process more efficient and less risky. Discover how Greenlight Guru can accelerate your product development at www.greenlight.guru.

The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.Will we need to retest everything?Is this a complete game-changer, or just an evolution?How will Notified Bodies and the FDA react?In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi hosts Marina Daineko, biocompatibility consultant at Intrinsic Medical Group, to unpack what's really coming.This episode covers:The background and current status of the ISO 10993-1 revisionWhy the new version is best seen as an evolution, not a revolutionHow the standard pushes further into a risk-based, scientifically justified approachThe link with ISO 14971 and lifecycle thinkingChanges in contact categorization and cumulative exposureThe industry trend toward reducing animal testing through in vitro methods and data-driven justificationHow to conduct a gap analysis once the new standard is publishedPractical advice on how to prioritize updates without freezing projects or panickingReal-world examples where process chemicals, not base materials, changed the risk pictureHow Intrinsic Medical Group supports companies with biological evaluation, cleanliness, sterilization and reusable devices

In this episode, Joe talks with Michigan's director of the Department of Licensing and Regulatory Affairs, Marlon Brown, DPA, about his path into public service and the wide scope of LARA's work. They cover everything from Michigan's economic landscape to ongoing efforts to streamline regulation, including an additional pathway for CPA licensure.

The Friday Five for November 21, 2025: Update on Telehealth Prescription Flexibilities Google Calendar Tasks Feature Medigap F, G & J Deductibles for 2026 Medigap K & L Out-of-Pocket Limits for 2026 Medicare Part A & B Premiums & Deductibles + MA, MAPD & Medicare Part D Premium Projections   Get Connected:

In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and regulatory consulting for medical devices. This article covers: Helene's personal journey from employee to entrepreneur The early risks and decisions that shaped Qmed's growth How the company's services and markets evolved over time A deep dive into clinical evidence generation vs equivalence The seismic impact of EU MDR on clinical strategies PMCF pitfalls and real-life examples Working with Notified Bodies and new expectations under MDR Lessons from projects that didn't go as planned The crucial alignment between clinical data and human factors Practical advice for startups on avoiding top regulatory mistakes Her vision of the future: RWE, adaptive study designs, digital health & greater regulatory convergence Links: Helene Quie: https://www.linkedin.com/in/helene-quie-863a323/ Qmed Consulting: https://qmed-consulting.com/ Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Curtis Smith (TNLA Director of Legislative & Regulatory Affairs) sits down with Arnulfo Hinojosa, COO of FEWA, to break down the latest changes to the H-2A program following the U.S. Department of Labor's new Interim Final Rule. In just 30 minutes, we cover what employers in the nursery, greenhouse, and landscape sectors need to know heading into the 2026 filing season — including new wage calculations, advertising requirements, incidental tasks, staggered start dates, interview waivers, and the broader legal landscape surrounding H-2A. Topics include: • What's now in effect under the Interim Final Rule • How OEWS wage data, skill levels, and the Adverse Compensation Adjustment will impact pay • Best practices for advertising wages and retaining returning workers • Clarifying incidental tasks and job-order scope • How staggered start dates and interview waivers work under the new system • What lawsuits and regulatory shifts mean for employers • Practical next steps for green-industry operations preparing 2026 applications A timely conversation for anyone navigating seasonal labor, compliance, and workforce planning under the evolving H-2A program.

The FDA Group's Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations should be preparing for now.Maria draws on two decades of leadership across nonprofit, government-funded clinical research, and biomedical science programs—spanning patient registries, clinical trials, multi-stakeholder consortia, DEI initiatives, and regulatory strategy. As the head of DIA's global science and regulatory portfolio, she works closely with regulators, industry sponsors, academia, and technology developers to advance responsible, evidence-driven innovation.In this conversation, Maria breaks down the reality behind AI in the regulatory ecosystem: what's currently in use, how agencies are evaluating and validating tools, why risk-based tiers matter, and how the field is moving toward lifecycle oversight rather than one-time checks. She also highlights the ethical and equity considerations that must be embedded from the start and shares insights from global regulatory trends and DIA's convening role.Key topics discussed include:How regulatory agencies are already using AI internally for document-heavy workflows, safety surveillance, and information retrievalWhy validation must focus on end-to-end workflow integrity, not just the modelThe emerging role of risk-based tiers for AI-enabled toolsThe importance of lifecycle control frameworks such as TPLC and PCCPsGlobal convergence themes around transparency, bias mitigation, and human accountabilityHow agencies are preparing for increasing AI adoption—and what industry teams should be doing nowDIA's role as a neutral convener helping harmonize expectations and accelerate responsible innovationAbout The FDA GroupThe 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/

We're counting down to the annual Turkey Burn, but why is there so much confusion this year?Peloton's earnings call happened. We recap the key takeaways for your fitness investment.Peloton's new event hub seems to be missing some key events.Peloton & HYROX are partnering for a special fitness event in Dallas.A weird mileage glitch is plaguing some Peloton Tread runs.Finding a Peloton showroom is now easier thanks to the new store locator on the website.mPaceline announced a major change that affects how you track your fitness data.Peloton is hiring a Head of Compliance, Policy, & Regulatory Affairs.Instructor Jon Hosking is making his way to PSNY.Hannah Corbin is featured in Oprah Daily.Get the tea! Tea Time with Cody Rigsby is officially back.Christine D'Ercole opens up about testosterone and menopause.Selena Samuela has shared her baby's due date.The latest Peloton Artist Series features the music of Anastacia.There's even more new music from Armada Music hitting the platform.SoulCycle is making a move into the strength fitness space.We share the TCO Top Five, a weekly recap of the community's favorite Peloton classes.Find out what's happening "This Week at Peloton."Our TCO Radar highlights the upcoming classes we're most excited about.New Peloton Run Club dates have been announced.The "Move As One" classes are now available.Erik Jager has a brand new 90-minute Power Zone Ride for endurance lovers.Charlotte Weidenbach has launched a new fitness program.Peloton has organized classes into several new and helpful Collections.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs. In this podcast episode, Hatem Rabeh joins to demystify how AI can be used — and where it must be handled carefully. We discuss: The reality behind “AI replacing QA/RA jobs” Key tools: n8n, Make, Zapier, OpenAI, and OpenFDA Building automation workflows for regulatory monitoring and documentation Managing data privacy, confidentiality, and local vs cloud solutions The cost, setup time, and risks of AI hallucination How to use AI safely and ethically in regulated environments

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.

This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠RQMplus.com⁠.Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.We cover practical implications of recent and emerging regulations, including:Batteries Regulation (EU) 2023/1542AI Act (EU) 2024/1689Packaging and Packaging Waste Regulation (EU) 2025/40European Health Data Space Regulation (EU) 2025/327You'll learn:About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.How to identify all applicable legislation for your product and verify coverage.What notified bodies expect to see and the typical level of scrutiny.How to structure your compliance register, QMS updates, and regulatory reporting.Transition timelines and planning tactics to avoid last-minute surprises.Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.Panelists and moderator:Greg Griffin, PhD, MRSE – Technical Specialist, BSIClaire Burrows – Regulatory Partner, BrabnersChris Parr, PMP – Principal, RQM+Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)--

US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers. You'll learn: Which FDA activities continue, and which are suspended How submissions like 510(k), PMA, and De Novo are impacted What happens to clinical trials, recalls, and ongoing investigations Whether this situation has happened before and how long it could last How companies can prepare and what contingency actions to take

Jeff Brightwell visits with Katherine Sulentic, Deputy Athletics Director, Regulatory Affairs / SWA, about her background working on both sides of the NCAA, what she saw in Dr. Ed Scott, and operating at a “Power” level.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength. You'll learn: What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE) How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA) How EU MDR uses RWE through PMCF and PMS The key differences in approach between the two regions A practical 5-step roadmap to build a compliant RWE strategy Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them

What waters are considered “waters of the United States” or WOTUS under the Clean Water Act (CWA)? This question is critical because it determines which waters are regulated under the statute. The EPA and the U.S. Army Corps of Engineers have struggled to develop a definition that can pass legal muster, in large part because they have tried to regulate waters that go beyond their statutory authority. For many years, the courts didn’t provide clarity either. But in 2023, the US Supreme Court in Sackett v. EPA specified what waters are regulated, including to what extent wetlands are covered. Currently, a new proposed WOTUS rule is being reviewed by the Office of Information and Regulatory Affairs. What should the rule include and what is required for the rule to be consistent with Sackett? The Competitive Enterprise Institute’s Daren Bakst discusses this important issue with Charles Yates, an attorney at the Pacific Legal Foundation who was on the litigation team that represented Chantel and Michael Sacket before the US Supreme Court.

In this masterclass episode of Skin Anarchy, Dr. Ekta Yadav sits down with Dr. Julie Faitg, Senior Manager of Applied Research and Regulatory Affairs at Timeline, to uncover how mitochondrial science is transforming the future of skin longevity.Dr. Feitge challenges the familiar “powerhouse” analogy, instead calling mitochondria the “CEO of the cell.” Far from passive energy producers, these organelles orchestrate communication, repair, and renewal—directly influencing collagen production, elasticity, and cellular resilience. “If your mitochondria aren't healthy,” she explains, “the entire cascade of cellular function begins to falter.”Through vivid analogies, Dr. Feitge describes how mitochondria behave differently across tissues—fueling endurance in muscles, focus in the brain, and regeneration in the skin. This adaptability, she notes, is what makes them the foundation of both vitality and longevity.The conversation dives into mitochondrial resilience, the skin's ability to repair and recover from stress. Aging begins when this resilience declines, leading to diminished energy, slower renewal, and visible signs of fatigue.Dr. Faitgd highlights Timeline's breakthrough ingredient, Mitopure® (Urolithin A)—a clinically validated compound that triggers mitophagy, the process of recycling damaged mitochondria. In trials, topical Mitopure® improved collagen expression, hydration, and firmness while reducing inflammation and UV-induced stress.Developed in Switzerland under rigorous safety and precision standards, Timeline's skincare line redefines beauty as m—a shift from treating the surface to revitalizing the source.