Podcasts about Regulatory affairs

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.

This week, Hemish is joined by Ashley Preston, SVP of Regulatory, Quality and Medical Writing at Blossom Hill Therapeutics, for a conversation about what it really takes to win hearts and minds early in quality leadership.Ashley took an unconventional path into QA, stepping into his first Quality leadership role after a long career in Regulatory Affairs.Because of that, he's had to lead through something far more important than technical depth: communication, trust, and people.In the episode, Ashley shares:Why he moved from Regulatory into Quality leadershipHow to build trust quickly when you're new to QAHow leaders can empower technical experts and still influence effectivelyPractical ways to build quality systems and culture in a small biotechWhy communication, self-awareness and soft skills matter more than everHow quality can earn a stronger, more strategic voice at the executive tableAshley's perspective is grounded, pragmatic, and incredibly relevant for leaders in emerging and clinical-stage biotech.#QualityLeadership #Biotech #RegulatoryAffairs #QualityCulture #LetsTalkQuality

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.

Unlock practical strategies for mastering performance as a leader!

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.

Environmental, Social & Governance – kortweg ESG. Drie letters die staan voor een wereld van verandering, optimalisatie en regelgeving. Voor menig MKB-bedrijf misschien nog een ‘ver van mijn bed show', maar voor toeleveranciers van grotere ondernemingen al een dagelijkse realiteit. Wat houdt ESG precies in? Maar ook: hoe ga je hier in de praktijk mee om? En wat moeten fiscalisten hiermee? Djoeke Altena is Manager Public Affairs & Regulatory Affairs bij Neste en voor hem is ESG dagelijkse kost. Maar Djoeke is ook als schrijver verbonden aan de wekelijkse rubriek Parlementair in het Weekblad fiscaal recht en dus de verpersoonlijking van ‘the best of both worlds'. Hoor in de RB Podcast hoe je als adviseur effectief kunt bijdragen aan duurzame transities binnen het MKB. In gesprek met Sylvester Schenk, directeur fiscale zaken van het RB en de vaste host van de RB Podcast.Regelmatige luisteraar van de RB Podcast? Laat ons weten wat je er van vindt én stuur ons suggesties voor nieuwe afleveringen

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.

"5G is becoming a great enabler for industries, enterprises, in-building connectivity and a variety of use cases, because now we can provide both the lowest latency and the highest bandwidth possible,” states Ganesh Shenbagaraman, Radisys Head of Standards, Regulatory Affairs & Ecosystems.In the recent episode of the Tech Transformed podcast, Shubhangi Dua, Podcast Host, Producer, and Tech Journalist at EM360Tech, speaks to Shenbagaraman about 5G and edge computing and how they power private networks for various industries, from manufacturing, national security to space.The Radisys' Head of Standards believes in the idea of combining 5G with edge computing for transformative enterprise connectivity. If you're a CEO, CIO, CTO, or CISO facing challenges of keeping up the pace with capacity, security and quality, this episode is for you. The speakers provide a guide on how to achieve next-gen private networks and prepare for the 6G future. Real-Time ControlThe growing need for real-time applications, such as high-quality live video streams and small industrial sensors with instant responses, demands data processing to occur closer to the source than ever before. Alluding to the technical solution that provides near-zero latency and ensures data security, Shenbagaraman says:"By placing the 5G User Plane Function (UPF) next to local radios, we achieve near-zero latency between wireless and application processing. This keeps sensitive data secure within the enterprise network."Such a strategy has now become imperative in handling both high-volume and mission-critical low-latency data all at the same time. Radisys addresses key compliance and confidentiality issues by storing the data within a private network. Essentially, they create a safe security framework that yields near-zero latency to guarantee utmost data security.Powering Edge Computing ApplicationsThe real-world benefit of this zero-latency setup is the power it gives to edge computing applications. As the user plane function is the network's final data exit point, positioning the processing application near it assures prompt perspicuity and action."The devices could be sending very domain-specific data,” said Shenbagaraman. “The user plane function immediately transfers it to the application, the edge application, where it can be processed in real time."It reduces errors and improves the efficiency of tasks through the Radisys platform, with the results meeting all essential requirements, including compliance needs.One such successful use case spotlighted in the podcast is the Radisys work with Lockheed Martin's defence applications. "We enabled sophisticated use cases for Lockheed Martin by leveraging the underlying flexibility of 5G,” the Radisys speaker exemplified. Radisys team customised 5G connectivity for the US defence sector. It incorporated temporary, ad-hoc networks in challenging terrains using Internet Access Backhaul. It also covered isolated, permanent private networks for locations such as maintenance...

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

Join Caroline Shleifer, Founder & CEO of RegASK, as she explores how artificial intelligence is reshaping the global regulatory landscape—empowering companies to navigate complex compliance frameworks faster, smarter, and more efficiently. Learn how AI-driven insights are driving a new era of transparency, agility, and innovation across healthcare, life sciences, and global markets. Insights You'll Learn: AI in Regulation – how automation is transforming compliance and oversight Regulatory Intelligence – using data-driven insights to predict and manage change Global Compliance Challenges – adapting to shifting policies worldwide Innovation in Healthcare Regulation – improving safety, speed, and market access Future of Regulatory Tech – trends shaping the next decade of compliance Leadership in Deep-Tech – building AI systems for complex, high-stakes industriesWhy This Matters:The pace of regulation is accelerating across healthcare, biotech, and AIManual compliance processes are no longer sustainable — AI is essentialGlobal companies need real-time, curated regulatory intelligence to competeCaroline's expertise bridges science, law, and technology — a rare intersection driving global impactExpert Background:• Founder & CEO, RegASK – global AI-powered regulatory intelligence platform• PharmD–PhD in Medical Physics – deep expertise across healthcare and compliance• Thought leader in AI governance, healthtech regulation, and global policy innovation• Passionate about leveraging technology to simplify global compliance and accelerate innovation Perfect For: Regulatory professionals, compliance leaders, healthtech founders, AI innovators, policymakers, and anyone shaping the future of global governance and ethics in technology. Timely Topic: As regulations evolve to keep pace with AI innovation, understanding how AI is redefining regulatory strategy is critical for every organization operating in the digital age.Subscribe for more global founder conversations from GSD Venture Studios:GSD Venture Studios: https://gsdvs.com#AI #RegTech #RegulatoryIntelligence #Compliance #HealthcareInnovation #FutureOfAI #GlobalRegulation #HealthTech #AICompliance #TopGlobalStartups #Innovation #DigitalTransformation

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What's Regulatory Affairs? How does R&D fit in?In this video, I walk through eight of the most common roles you'll find in pharma, medtech, biotech, and diagnostics companies. We'll talk about what each team does, how they connect, and how to think about which one might fit your strengths and interests.If you're trying to figure out where you belong in industry, this one's for you.Please like, share, and subscribe if you find it helpful!Timestamps00:00 Introduction and Background01:07 Overview of Industry Roles02:43 Quality Assurance06:14 Regulatory Affairs08:22 Research & Development09:46 Clinical Affairs11:07 Manufacturing & Operations12:09 Quality Control / Analytical Testing14:05 Supply Chain & Procurement15:13 Validation & Technical Services16:39 Career Path Insights and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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.

Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities. This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them: Understanding the shift from MDD to MDR (Article 61 & Annex XIV) Why weak Clinical Evaluation Plans (CEPs) lead to rejection How to generate and analyze real, device-specific clinical data Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system Maintaining a “living” Clinical Evaluation Report across the device lifecycle

Coruna Medical's Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement.Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environments and keeping people confident under pressure. He outlines the four-room model for inspection management, strategies for responding to observations, and proven methods for closing data-integrity gaps while daily operations continue.Jeff and Nick also explore the leadership mindset that sustains progress beyond the initial response—fostering transparency, prioritization, and a culture of accountability that prevents repeat findings.Topics discussed include:The leadership posture that steadies teams during inspections and remediationHow to stand up the four-room inspection model (Front, Back, Doc-QC, SME-Prep)Responding to 483s: when to push, when to accept, and how to align internallyData-integrity vulnerabilities and effective interim controlsBalancing remediation with production demandsBuilding transparency and accountability into quality cultureKeeping systems current to avoid backsliding into repeat observationsAbout 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/

In the October Almond Byte, get the latest global trade updates from ABC's Global Technical and Regulatory Affairs team. Highlights include Turkey's removal of retaliatory tariffs on almonds — a potential major win for market growth — plus ongoing trade discussions with India, updates from Washington, and insight into how diversification is strengthening export stability worldwide. You'll also meet new ABC team member Lindsay Tello, joining as Keith Schneller transitions toward retirement, and get a preview of key global trade sessions planned for The Almond Conference, December 10–12 in Sacramento.

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.

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

The FDA Group's Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization.With nearly 30 years of leadership experience spanning pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory, clinical, scientific affairs, and operations. He brings a rare, holistic view of how leadership, culture, and systems thinking come together to drive successful outcomes in complex, regulated environments.Their conversation explores how to balance innovation and compliance, structure cross-functional teams for consistent execution, and foster cultures that prioritize transparency, collaboration, and patient focus.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: https://www.thefdagroup.com/

The Commerce Commission has ruled out an inquiry into airport regulation, for now. Air New Zealand had written to the regulator, saying there was enough 'accumulated evidence and concern' to justify a probe. The Commission has done a 'short, targeted review'. Air New Zealand Head of Regulatory Affairs Kristy McKay revealed why she's pleased with this outcome. LISTEN ABOVESee omnystudio.com/listener for privacy information.

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

The recent PJM Governors' Conference in Philadelphia spotlighted surging electricity demand, political scrutiny, and concerns over rising power bills. Governors, regulators, and industry experts gathered to debate the future of PJM Interconnection, which directs the flow of power to 67 million people in 13 states and DC. In this episode of Energy Solutions, EPSA President and CEO Todd Snitchler sits down with four panelists who were part of the conversation to go beyond the headlines and delve into why costs are rising, what states are considering, and actionable solutions to enable competitive markets to deliver reliable, cost-effective power:  Travis Kavulla, Vice President of Regulatory Affairs, NRG   Marji Phillips, Senior Vice President of Wholesale Market Policy, LS Power   Glen Thomas, President, P3   Arnie Quinn, Senior Vice President of Regulatory Policy, VistraLiked this episode? Share it on X @EPSANews or LinkedIn at Electric Power Supply Association. Want more competitive power updates? Sign up for our monthly Power Moves newsletter.

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

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.

The FDA Group's Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores FDA/ICH's new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. Regina explains why pregnant and breastfeeding women have historically been excluded from research, how that has left clinicians and patients with insufficient evidence, and why E21 represents a cultural and scientific shift toward safe, risk-based inclusion.Read the draft guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trialsRegina shares practical insights on:How physiologic changes in pregnancy alter drug absorption, distribution, metabolism, and elimination.The dangers of underdosing, overdosing, or avoiding treatment altogether in the absence of trial data.Why clinicians should avoid inappropriate substitutions (e.g., some NSAIDs) and instead rely on evidence-based dosing.How E21 encourages continued monitoring of participants who become pregnant during a trial rather than automatic withdrawal.The stepwise approach to lactation studies—starting with breast milk concentration, then estimating infant dose, and eventually assessing infant exposure and safety.The role of PK/PD modeling, nonclinical data, and real-world evidence in bridging evidence gaps.How sponsors can engage FDA early to align on inclusion triggers and maternal–fetal expertise.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: https://www.thefdagroup.com/

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/

FLEET RENEWAL & FUELS – A REALITY CHECK Moderator: Ms. Cristina Saenz de Santa Maria, Chief Operating Officer – DNV MaritimePanelists: Ms. Sanne Henriksen, Head of IMO and EU, Public & Regulatory Affairs – A.P.Moller Maersk Ms. Marie-Caroline Laurent, Group Senior Vice President, Head of GovernmentAffairs & Maritime Policy – Mediterranean Shipping Company S.A. (MSC) Mr. Hamish Norton, President – Star Bulk Carriers Corp. (NASDAQ: SBLK) Mr. Haris Zografakis, Partner – Stephenson Harwood LLP Mr. William Fairclough, Managing Director – Wah Kwong Maritime Transport 17th Annual Capital Link Shipping & Marine Services Forum Tuesday, September 16, 2025BMA House, London Ιn partnership with ABSΙn conjunction with the 2025 London International Shipping Week

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 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".

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