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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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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Listen Medical Device Regulation and Standards
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Introducing Left to Our Own Devices - the podcast dedicated to everything product security. Every other week, we will be talking with a different cybersecurity policymaker, engineer, or industry leader to hear their war stories and get their insider tips for surviving the product security jungle. From Medical SBOMs, to WP. 29 and the latest industrial security threats, this is your place to catch up and learn from the pros. Left to Our Own Devices is brought to you by Cybellum. To learn more ...
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Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
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Today’s health care industry is a high-stakes environment full of legal, policy, and regulatory-related obstacles. There are also tremendous opportunities, and in order to thrive, it is critical for executives, general counsel, and administrators to have a consistent pulse on trends and available business solutions. Subscribe to our health care podcast, Diagnosing Health Care, for thought-provoking, strategic insights from Epstein Becker Green attorneys and health care professionals.
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This Food Industry focused podcast brings together Xtalks editorial staff to share insights into the latest B2B industry news. Xtalks connects professionals in the life science, medical device, and food industries with useful content like webinars, job opening, articles and virtual meetings.
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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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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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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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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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Animal Radio® is America's "most-listened-to" animal programming; created to educate, reduce surrenders and to help animals live long, healthy and happier lives.
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We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.
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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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1285. 'Sally Forth' Writer Francesco Marciuliano Transcribes Cat's Poetry - "I Can Pee On This"
1:20:29
1:20:29
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I Could Pee On This Our special guest is Francesco Marciuliano. He's the author of the Sally Forth comic strip that runs in over 700 newspapers and a series of pet poetry books that he says he transcribed from his cat. Not bad for a kid with a "Bucket List" at ten years old. You'll laugh until you hurt! Listen Now $1 Million Lawsuit Over Dog That W…
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Live! #80 – Beyond EtO: New EPA Regulations and Sterilization Alternatives
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This was recorded 18 July 2024. We encourage you to download the 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 to more traditional webinars) and you ca…
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Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court
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In a recent landmark decision, the U.S. Supreme Court overruled the Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo. This ruling has significant implications for employers and other entities in the health care and life sciences industries, as it changes the way courts are likely to interpret and apply regulations issued by fede…
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Helping Food and Beverage Companies Solve Compliance and Production Issues: Interview with Matt Brown, Wherefour
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This episode of the Xtalks Food Podcast features an interview with with Matt Brown, CEO of Wherefour, a cloud-based ERP (enterprise resource planning) platform that helps food and beverage companies, large and small, solve production and compliance issues. Matt discusses his background and what led him to lead Wherefour. He talks about why ERP plat…
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The number of senior citizens is growing rapidly; individuals aged 65 and older increased from 39.6 million in 2009 to 54.1 million in 2019 (a 36% increase) and is projected to reach 94.7 million by 2060. However, over the last few years, the usual respect and care of our aging population is decaying into a growing incidence of neglect and abuse. P…
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Navigating Regulatory Landmines for Combination Products – MedTech CRO: Regulatory Expertise 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.* While she has moved towards retirement since recording this vi…
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Culture & Compliance Chronicles: A Journey into Team Ethical Culture with Guillem Casoliva Cabana
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On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab, and Richard Bistrong of Front-Line Anti-Bribery, delve into the intricacies of corporate culture and compliance with special guest Guillem Casoliva Cabana. A seasoned traveler and compliance manager at Booking.com, Guillem takes us…
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In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure that patients' voices are not only heard but also central to decisions affecting their health. They play a crucial role in various aspects: Firstly, patient advocates are instrumental in representing t…
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How to Build and Manage a Powerful Advisory Board featuring Paul Hickey
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Send us a Text Message. In this episode, the discussion centers around the crucial role of advisory boards in guiding company strategies, product development, and business initiatives within the medical device sector. Featuring insights from Paul Hickey, CEO of ReShape Life Sciences, the conversation delves into best practices for forming and manag…
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Join us as we dive into the journey of Ashwini Siddhi, Director of Product Security Engineering at GoDaddy. Ashwini shares her experiences from Dell to GoDaddy, her expertise in threat modeling, and the pivotal role of Bengaluru in her career. We also explore her advocacy for diversity and inclusion in cybersecurity and her influential mentorship w…
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This conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients. Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals ar…
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More and more regulations have to be applied in parallel of the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will be explaining to us what are these additional requirements. He will also confirm that Notified Bodies can ask you questions about it and finally he will share some key timelines …
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SCOTUS and the Future of the Administrative State: After Jarkesy and Loper Bright
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The U.S. Supreme Court’s term has ended, with major implications for federal agencies and those that are regulated by them. What did the Court cover? And what remains unaddressed? Join litigation & enforcement partners Doug Hallward-Driemeier and Jeremiah Williams as they discuss the impact of Jarkesy and Loper Bright on federal agency authority, i…
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Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series
19:20
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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.* Combination Device Clinical Trials: Strategy & Tactics Join RQM+…
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Decoding Digital Health: Conversation with Dr. Bernardo Bizzo, Mass General Brigham AI
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On this episode of Ropes & Gray’s podcast series, Decoding Digital Health, Christine Moundas, a health care partner and co-chair of the firm’s digital health initiative, is joined by Dr. Bernardo Bizzo, a senior director at Mass General Brigham AI and assistant professor of radiology in the Department of Radiology at Mass General Hospital. Dr. Bizz…
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Why Drug Accountability Matters in Clinical Trials
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Drug accountability is a critical aspect monitored by the FDA at clinical trial sites. Principal investigators must maintain and document control over investigational products, ensuring they are only administered under direct supervision. Clinical research organizations also conduct routine audits to verify drug accountability. However, instances o…
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The EU’s Artificial Smoke Ban + Sugar Reduction Technologies
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The European Union (EU) recently introduced a ban on eight artificial smoke flavorings used in various food products. This move is part of an effort to protect public health from potential cancer risks associated with these additives. In this episode of the Xtalks Food Podcast, Sydney talks about the ban, which was endorsed by member states in Apri…
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1284. Being A Vet Saved Her Life - How Far Would You Go To Save Your Pet's Life?
1:19:56
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Being A Vet Saved Her Life When Veterinarian Dr. Sarah Boston noticed a lump on her body, she insisted that it was cancerous, even though other doctors said no. She did an ultrasound at her office and validated her worst fear. The lump was removed, and she is now cancer-free. Listen Now What Would You Do For Your Dog? When this week's Hero Person f…
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How the Regulatory State May Change in the Aftermath of the SCOTUS Chevron Ruling
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The Supreme Court has discarded the Chevron doctrine. In a decision overturning a four-decades-long precedent, the high court now says courts will no longer so easily defer to federal agency interpretations of the statutes they implement. The demise of so-called “Chevron deference” could upend the regulation of nearly all aspects of American commer…
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The Data Day: Recent Developments in AI Governance and State Privacy Laws
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Tune in to the latest episode of Ropes & Gray's podcast series, The Data Day, brought to you by the firm’s data, privacy & cybersecurity practice. This series focuses on the day-to-day effects that data has on all of our lives as well as other exciting and interesting legal and regulatory developments in the world of data, and features a range of g…
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Legal Minute: What do I do if my med is on shortage?
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We discuss how to address drug shortages. First things first, it's important to stay calm. Just because there's a shortage doesn't mean you'll lose access to your medication entirely. Here are some action steps you can take: 1. Schedule an appointment with your doctor to discuss alternative medications that might be effective for you. It's crucial …
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How AI Can Transform Food Safety with Dr. Wesam Al-Jeddawi of Core Catalyst Food Sciences
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Join Lydia Adams on this episode of the Food Tech Talk podcast, where she interviews Dr. Wesam Al-Jeddawi, Executive Director of Laboratory Services at Core Catalyst Food Sciences. Dr. Wesam has a strong background in food science, microbiology, safety, and quality control, and is passionate about leveraging scientific innovation to advance food sa…
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You are working with a Software that contains an AI/ML algorithm then you should listen to this podcast episode and understand the requirements of the AI ACT to your medical device. Fabien Roy, lawyer will explain to us what are the challenges that he has identified for medical device manufacturers working with Artificial Intelligence. Who is Fabie…
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Key Aspects of Medical Device Clinical Trial Design (2/2) – MedTech CRO: Strategy Development Series
12:44
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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.* 💡🏥 𝗨𝗻𝘃𝗲𝗶𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝘀 𝗼𝗳 𝗦𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶…
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Chris Fontes and the US Hemp Authority Adult Certification Program
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Jonathan Miller interviews Chris Fontes, President of the US Hemp Authority about that organization's upcoming adult product certification program. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questions covered in the episode: Why did the US Hemp Authority decide…
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5 reasons not to use AI in creating pharma marketing content
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We discuss the risks associated with using AI in your pharma marketing plans: 1. Data Privacy and Security: Ensuring the security and privacy of data, whether it pertains to patients or non-patients, is paramount. 2. Bias: Questions arise regarding the sources of information, control over data, and addressing privacy concerns to prevent biases and …
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8 essential elements of a valid prescription
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In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse: Verify the prescriber's identity. Know the prescriber's DEA number. Know your patient thoroughly. Verify prescription dates for validity; ensure prescriptions are current. Communicate directly with prescribers if any concerns arise. Request identi…
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Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment
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🤔 Struggling with patient recruitment for your medical device clinical studies? Join RQM+ Clinical Trials COO David Novotny and THREAD CEO John Reites as they explore innovative hybrid study approaches to accelerate patient recruitment in MedTech research. In this conversation, you'll learn how hybrid approaches can: Expand your recruitment reach b…
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Medboard EU Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422 Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/ MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health…
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1283. Skunk Explosion - FDA Calls Out Tear Stain Remover Manufacturers
1:20:35
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Skunk Explosion Skunk researcher Christopher Kemp joins us. He's from England, and they don't have skunks in Europe. Ironically, Pepe' le pew is from the Americas. But the most important thing you'll learn is that tomato Juice doesn't remove the smell. Christopher will unlock the true secret to remove the stink and some other interesting facts abou…
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In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance …
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Nestlé Health Science's GLP-1 Nutrition Platform + Food IPOs of 2024
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Nestlé Health Science recently introduced an innovative platform, GLP-1 Nutrition. The newly launched website is designed to provide comprehensive nutritional support for individuals on their weight management journey, including those using glucagon-like peptide-1 (GLP-1) medications. In this episode of the Xtalks Food Podcast, Sydney talks about t…
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Legal Minute: 4 Ways to Get Unapproved Drugs Legally!
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Today, we discuss four legal pathways to acquire unapproved drugs. First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph. Second, compounded drugs crafted by pharmacists provide an alternative despite lacking FDA approval. Third, the FDA's new policy allows for state-imported drugs, provided certai…
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Scott Sheahan: From Aerospace to Automotive Cybersecurity
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We sat down with Scott Sheahan, the owner of Rustic Security, to learn from his rich background in the automotive cybersecurity world and embedded software development.By Cybellum Technologies LTD
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Key Aspects of Medical Device Clinical Trial Design (1/2) – MedTech CRO: Strategy Development 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.* ✏️ 𝗞𝗲𝘆 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 (𝟭/𝟮) Cari Kn…
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Non-binding Guidance: FDA Regulatory & Enforcement Risks Relevant to Academic Medical Centers, Health Systems and Research Institutions
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On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, counsel Steve Sencer moderates a discussion on how FDA regulatory issues may impact academic medical centers (AMCs), health systems, and universities/research institutions. Joined by partner David Peloquin, and counsel Sarah Blankstein and Beth Weinman, the episode explores the…
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FDA Regulatory & Enforcement Risks Relevant to Academic Medical Centers, Health Systems and Research Institutions
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On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, counsel Steve Sencer moderates a discussion on how FDA regulatory issues may impact academic medical centers (AMCs), health systems, and universities/research institutions. Joined by partner David Peloquin, and counsel Sarah Blankstein and Beth Weinman, the episode explores the…
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1282. Bestselling Author Dean Koontz Bought His Dog A Typewriter
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Dean Koontz is Back Award-winning, best-selling author Dean Koontz returns to Animal Radio airwaves to tell us the story about his dog, Anna. According to Dean, Anna purchased a computer and started answering advice emails. Tune in to hear the rest of the story. Listen Now Dog Food Advisor Dr. Mike Sagman was a dentist until he gave that up to crea…
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The 4 Building Blocks of Using AI in any Pharma Marketing Strategy
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We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use: 1. Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive compliance plan for AI use. Without clear goals, executing a successful strategy becomes challenging. 2. Establish Policies and Procedures: Clearly defined pol…
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Risk Management In Clinical Trials – MedTech CRO: Strategy Development 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.* 🛡️ 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Senior Director of Clinical Oper…
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Insights Into the Irish Food Industry: Interview with Sheelagh Daly, Enterprise Ireland
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This episode of the Xtalks Food Podcast features an interview with with Sheelagh Daly, the Foreign Direct Investment (FDI) manager at Enterprise Ireland, the government organization responsible for the development and growth of Irish enterprises in world markets. Sheelagh begins by talking about her role as FDI manager and discusses some of the lat…
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