A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.
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Welcome to The Sidley Podcast. Join us as we bring a unique perspective to complex issues at the intersection of law and business.
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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues ...
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Welcome to Food Tech Talk: Supply Chain Insights From Farm to Fork, a bite-sized podcast discussing the latest trends and technology in the food and supplements industries, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. Together, we are on a mission to change the food and dietary supplement industry for the better. In short snippets, guests will discuss a range of topics, from regulatory compliance to sustainable operat ...
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RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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Listen Medical Device Regulation and Standards
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ t ...
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Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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The $1 Pound Show dives deep into the cannabis industry. We discuss and document the transition happening with marijuana. From the black market to grey market finally to a regulated market. California has recently legalized cannabis and is currently figuring out it's regulations. Guests include, cultivators, extractors, lawyers, doctors other business owners.
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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Anesthesiology News will be publishing a new season of our popular podcast series, “On the Case” and “Ask the Experts.” “On the Case” is a review series that features the authors of our popular case report series. We hear the behind-the-scenes story on the most unique clinical case studies published in the magazine directly from the professionals who managed them. The first episode of this new season features an interview with L. Jane Stewart, MD, JD, MPH, who co-wrote a case report about a ...
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SNEED-CAST is brought to you by Sneed Coding Solutions! Tune in to hear the latest news regarding the coding and marking industry in addition to deep dives on certain subjects in the manufacturing and packaging industry!
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16 Minutes on the News is a short news podcast where we cover the top headlines of the week, the a16z podcast way -- why are these topics in the news; what's real, what's hype from our vantage point; and what are our experts' quick takes on these trends? About the a16z Podcast: Discusses tech and culture trends, news, and the future -- especially as ‘software eats the world’. It features industry experts, business leaders, and other interesting thinkers and voices from around the world. This ...
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On the "Making it to Market" podcast, we discuss everything about brand inception and product/service creation through to commercialization. Industry experts and business owners are invited to share their insights and best practices related to business planning, legal and regulatory considerations, manufacturing, supply chain, marketing, merchandising, B2B buyer methodology and B2C consumer psychology.
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Drug Fix: New US FDA Developments In AI Regulation
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Pink Sheet reporter and editors discuss new developments in the FDA’s plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development.More On These Topics From The Pink Sheet Artificial Intelligence: CDER’s New Council Takes Char…
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Improving Human Healthcare With Health-Related Quality of Life (HRQOL) Assessments
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In this podcast, Janelle Hart, Managing Editor at Citeline, teams up with industry experts Mai Yee Mishir, Senior Director of Global Regulatory Affairs, and Sally-Ann McDowell, Senior Director of Clinical Development Strategy at Advanced Clinical, to discuss the vital role of HRQoL in clinical trials. Listen now.…
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Integrating Joy and Nutrition: Strategies for Dieticians from Chef Phoebe Lapine
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Join Lydia Adams as she interviews Phoebe Lapine, a chef, wellness advocate, and author of "The Wellness Project" and "Carbivore." Phoebe shares her unique journey from culinary expert to health-conscious cookbook creator, offering a fresh perspective on the intersection of delicious food and nutritious eating. Throughout the discussion, Phoebe del…
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Data Management In Clinical Trials (Maintenance/Closeout) – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🎉 The data management party continues! Part 2 of o…
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Scrip's Five Must-Know Things - 2 September 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 30 August 2024. In this episode: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery.https://sc…
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Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Gaming; DHCoE On AI; Hello Heart
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In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people reco…
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Data Management In Clinical Trials (Setup Phase) – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🎉 It's a data management party – you in? Our team ha…
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Joshua Nott, Technical Program Lead (Jordi Labs) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series of interviews with RQM+ employees returns today as Christine Santagate, RAC is joined by enthu…
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Exploring The Postbiotic Opportunity In Consumer Health, With Kerry’s Sonja Nodland
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Interest in the human gut microbiome and the influence it exerts on a person’s wellbeing, from cognitive health to immunity, has been rapidly increasing in recent years. In this episode of HBW Insight's Over the Counter podcast we speak to Dublin-based food company Kerry Group about a particularly exciting, emerging area of microbiome-based wellnes…
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In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field. Who is Stephen O’Rourke? Stephen O’Rourke, based in Berlin, Germany, is a seasoned …
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Scrip's Five Must-Know Things - 26 August 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 23 August 2024. In this episode: CMS’s price reveal better than expected?; new diabetes risk data for Zepbound; can J&J’s lung cancer combo stand up to Tagrisso?; new recruits for BioMarin leadership; and Glenmark’s shifting revenues.https://scrip.citeline.…
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August 2024 Datamonitor Healthcare Podcast: The Colorful Landscape of Therapeutic Psychedelics
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Following the recent FDA rejection of MDMA therapy for PTSD, Emma and Flora discuss the future role of psychedelics in the treatment of mental health disorders. Content warning: This episode does contain mentions of sexual assault and abuse.Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcas…
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The Legal Battles Taking Shape in the Clash Over Internet Content
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A federal law known as Section 230 has provided a powerful legal shield for internet companies for nearly three decades. Designed to “promote the internet,” it protects platforms from civil liability for content posted to their sites by third parties. But the measure is inspiring lawsuits from plaintiffs who say it allows internet companies to esca…
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Bringing Gen Z To The Manufacturing Workforce with Jake Hall
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Welcome to the latest edition of SNEED-CAST, where insightful discussions meet industry expertise. In this episode, we have the privilege of hosting Jake Hall, The Manufacturing Millennial! We talk with Jake about his passion for the manufacturing industry and how the industry is a great place for younger generations to develop their career for the…
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Subscriber-only episode We dive into the critical issue of racial bias in AI, highlighted by a recent Yale study focusing on ChatGPT. This has significant implications for clinical research sponsors, sites, and principal investigators. We also explore the FDA's perspective on AI in clinical trials, presented by Dr. Elzarrad. Overview of the Yale St…
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FSMA 204 and the Future of Food Safety: Insights from Kroger's Catherine Cosby
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In this insightful episode of Food Tech Talk, Lydia Adams interviews Catherine Cosby, Director of Food Safety and Regulatory Compliance at Kroger. With over 15 years of experience in the food industry, Catherine shares her journey and expertise in food safety. The conversation centers on FSMA 204 and its implications for the food industry, with Cat…
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In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance… Who is Ralf Gansel? With over a decade of experience in the medical heal…
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Bioprinting – An Innovative Tool That Is Revolutionizing Drug Discovery
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Keith Murphy, co-founder of Organovo, discusses the growing potential of bioprinting and how the company is using its technologies to study and develop treatments for inflammatory bowel disease (IBD).Av Citeline
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Gillian Schauer, Jessice Burgess and an Outlook on Hemp from State Regulators
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Jonathan Miller interviews Gillian Schauer, Executive Director of the Cannabis Regulators Association (CANNRA), and Jessica Burgess, Deputy General Counsel of the Massachusetts Department of Agricultural Resources, about hemp policy from the purview of state regulators. If you have questions about the episode or ideas for Hemp related topics, email…
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Scrip's Five Must-Know Things - 19 August 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 16 August 2024. In this episode: Merck & Co. steps into CD19 bispecific space; gene therapy patients rise, but slowly; Madrigal’s Rezdiffra plans; Korean biopharma financing recovering?; and approvals to watch out for in Q3.https://scrip.citeline.com/SC1507…
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Another Pharmacy owner Jailed in Fraud Case
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Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promotional compliance within the pharmacy industry, and we're here to explore them in detail. In a landmark case…
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Drug Fix: What We Learned From The First Batch Of Medicare Negotiated Drug Prices
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Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.More On These Topics From The Pink SheetMedicare Negotiation Announcement: Discounts From List Price Up To 79%, But Net Savings Unclear: https://pink.citeline.com/PS155128/Medicare-Negoti…
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Secrets of Site Selection and Monitoring for IVD Studies (Part 2/2) – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site …
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Secrets of Site Selection and Monitoring for IVD Studies (Part 1/2) – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site se…
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【3分で解説 世界のファーマ】第20回 欧州心臓病学会 注目の新薬候補は (Japanese-language podcast)
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世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちらWhat To Look Out For At ESC 2024https://scrip.citeline.com/SC150740/What-To-Look-Out-For-At-ESC-2024Av Citeline
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Live! #81 (with FDA) – Advancing Health Equity with IVDs & Medical Devices
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This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition …
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Sustainable By Design: Thermo Fisher's Meron Mathias On ESG Compliance And The Competitive Edge
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Compliance with environmental sustainability goals is no longer optional for medtech companies serving global healthcare markets. Thermo Fisher has made it a mission to be a leader in thought and actions in meeting Scope 1, 2 and 3 needs. Corporate VP and head of sustainability Meron Mathias explains the company's sustainability aims and methods, f…
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Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly. Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market …
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Navigating FDA's clinical trial expectations after approval
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Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs). PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-w…
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Scrip's Five Must-Know Things - 13 August 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 August 2024. In this episode: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer’s crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner.https://scrip.citeline.com…
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Why Purpose Is Key To Driving CHC Growth, With Haleon’s Bas Vorsteveld
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Since becoming a standalone consumer health company, Haleon has been driving awareness of public health issues such as chronic pain and children’s oral health. In this episode of Over the Counter, HBW Insight catches up with Haleon vice president and general manager Great Britain and Ireland Bas Vorsteveld, to find out more about why having a purpo…
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Drug Fix: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms
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Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03…
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Legal Minute: Do dietary supplements interact with drugs?
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Do dietary supplements interact with drugs? Many people think only prescription drugs can cause interactions, but dietary supplements can too. From an FDA perspective, a drug is defined by its claims and indications. Some supplements make drug-like claims and can interact with medications. Common examples include grapefruit juice and vitamin K, whi…
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In this audio, Dr. Anthony Fritz discusses Type 2 diabetes and the benefits of SGLT2 inhibitors. Learn how this treatment option can improve diabetes care.Av Citeline
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Understanding The Craft Brewing Industry with Jessica Infante
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Welcome to the latest edition of SNEED-CAST, where insightful discussions meet industry expertise. In this episode, we have the privilege of hosting Jessica Infante, managing editor at Brewbound! We'll explore employment trends in the craft brewing industry, attracting diverse consumer demographics, growth potential in non-beer beverages like seltz…
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How Expert Pharma Marketers Navigate Privacy
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In today's consumer landscape, privacy concerns reign supreme. Pharmaceutical and medical device manufacturers must prioritize meeting the expectations of this privacy-conscious generation. This begins with three key measures: 1. Consent Management: Clear communication about data usage is essential, aligning with regulations like CCPA and GDPR. See…
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비만치료제, 2024년 상반기 대형주를 지배하다 (Korean-language podcast)
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올해 상반기 일라이 릴리와 노보 노디스크의 주가가 가장 높은 상승세를 보인 반면, BMS와 길리어드의 주가는 가장 큰 폭으로 하락했습니다. Scrip의 글로벌 제약주 동향 기사를 요약한 내용입니다.https://scrip.citeline.com/SC150593/Obesity-Rules-Large-Cap-Stocks-In-First-Half-Of-2024Av Citeline
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Food Science Insights with Rachel Zemser of A La Carte Connections
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In this episode of Food Tech Talk, Lydia Adams interviews Rachel Zemser, a food science industry consultant with nearly three decades of experience. Rachel, the Founder of A La Carte Connections, shares her journey in the food industry and her passion for food science, which was sparked by her international upbringing and exposure to diverse food c…
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Tactical Considerations for IVD Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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Our ongoing educational video series on 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 covers three areas: ♟️ Strategy 🛠️ Execution ✅ Regulatory Optimize your IVD clinical trials and watch our newest video in the series: 𝗧𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗜𝗩𝗗 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀. Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., is joined by Senior Director of Clinical Opera…
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The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now. Who is Andreas Stange? Dr. Andreas F. Stange is a vi…
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Robert Hoban and the "War" Between Hemp and Marijuana
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Jonathan Miller interviews Robert Hoban, a leading national attorney in the hemp and cannabis space, about the brewing policy conflict emerging between the hemp industry and its cousins in the cannabis industry. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questi…
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Scrip's Five Must-Know Things - 5 August 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 August 2024. In this episode: Pfizer bullish on its oral GLP-1; BMS’s rising confidence about Medicare pricing of Eliquis; more long term data for Leqembi; NewAmsterdam’s CETP inhibitor shows promise; and a look at Mankind’s Bharat Serums buy.https://scri…
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Drug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes
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Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14).More On These Topics From The Pink…
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Site Monitoring In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🔄 We recently covered Site Selection In Clinical Trials an…
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Hiring New Employees in PharmaTech Companies
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Edye Edens, a consultant and attorney with a background in regulatory affairs, shared insights into her unexpected yet exciting role at Weave, a rapidly growing startup specializing in AI-driven solutions for regulatory content creation. Edye discussed her journey from freelance consultancy to joining Weave, highlighting the unique challenges and o…
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China Biotech Podcast - 2 August 2024 (Chinese language)
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RNK Pharma founder and CEO Yaning Wang joins Brian Yang to discuss Shanghai's latest biopharma stimulus policies and the globalization of China biotech. Dexter Yan also discusses China biotech initial public offerings in the first half of this year.Av Citeline
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How Drug and Device Companies Can Tackle Internet Misinformation
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On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray’s life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices …
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Site Selection In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🆕 Our newest video: 𝗦𝗶𝘁𝗲 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀. Senio…
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July 2024 Datamonitor Healthcare Podcast: The Future of Biologics in COPD
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COPD expert Wen-Yu discusses what the entrance of biologics might mean for the COPD treatment landscape and shares a sneak peek from her upcoming patient-based forecast.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.goo…
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The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more. Who is Erik V…
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