Podcasts about Regulatory affairs

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.  Who is Carmen Bellebna?  Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye's QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment.     Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Carmen Bellebna LinkedIn:  https://www.linkedin.com/in/men-be-a1828a81/   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 Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ 

In this episode of Seen & Herd, Paul Sousa, Director of Environmental Sustainability and Regulatory Affairs at Western United Dairies, recaps a significant "doubleheader" of meetings held on Cinco de Mayo—a CDFA hearing on Stop QIP Petition #5 and an afternoon Producer Review Board (PRB) meeting. He breaks down procedural updates, introduces new board members, discusses quota administration issues, and explores the intriguing possibility of using a state bond to retire quota. Paul also provides important guidance on ballot signature requirements ahead of June's upcoming referendum and dives into a tense series of hardship relief requests. Stay informed on how these developments may shape the future of the quota program in California.Resources:> Previous Episode: Breaking Down Quota Results with Anja Raudabaugh> CDFA Producer Record Update Form

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we'll let you know when and why you should involve them earlier. Listen to this episode.  Who is Aouda Ouzzaa?  Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD).  Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations.  As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges.  Whether you're developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success.    Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32  SmartQARA website: https://smartqara.com/  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 Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/  

U.S. EPA has made a concerted effort over the past several years to come into compliance with its obligations under the Endangered Species Act. Much of its efforts are driven by what is referred to as the Mega Suit by environmental groups, which are forcing deadlines on EPA to meet its obligations. During Potato Expo 2025, we sat down with two policy experts to talk about what the implementation of EPA's strategy will mean for growers.Guests: Mike Aerts, Vice President of Science and Regulatory Affairs, Florida Fruit & Vegetable AssociationMike Wenkel, Chief Operating Officer, National Potato CouncilThis podcast is possible thanks to our presenting sponsor, Syngenta. Delivering solutions to help producers face the potato industry's complex challenges, Syngenta provides growers with unmatched field expertise along with an array of effective products. Explore syngenta-us.com/spud-doctor to discover solutions for your potato-growing obstacles. 

Decades of trickle-down thinking hollowed out our government—and now the anti-democracy crowd is finishing the job. This week, legal scholar and former Biden advisor K. Sabeel Rahman joins Nick and Goldy to talk about what happens when the rule of law becomes optional, what the Biden administration got right (and what it didn't,) and why simply restoring the old system isn't enough. If we want a real democracy—one that can stand up to corporate power and actually deliver for people—we need to stop playing by outdated rules and start constructing a government that's faster, fairer, and fit for the modern world. K. Sabeel Rahman is a legal scholar, policy expert, and former senior advisor in the Biden administration, where he served as Associate Administrator at the Office of Information and Regulatory Affairs. A leading voice on democracy, governance, and economic justice, he is Demos's former president and a law professor at Cornell University. Social Media: ⁠@ksabeelrahman.bsky.social⁠ ⁠@ksabeelrahman⁠ Further reading:  ⁠Civic Power: Rebuilding American Democracy in an Era of Crisis⁠ Website: ⁠http://pitchforkeconomics.com⁠ Instagram: ⁠@pitchforkeconomics⁠ Threads: ⁠pitchforkeconomics⁠ Bluesky: ⁠@pitchforkeconomics.bsky.social⁠ Twitter: ⁠@PitchforkEcon⁠, ⁠@NickHanauer⁠, ⁠@civicaction⁠ YouTube: ⁠@pitchforkeconomics⁠ LinkedIn: ⁠Pitchfork Economics⁠  Substack: ⁠The Pitch⁠

Earl Adams Jr., Vice President for Policy and Regulatory Affairs, Plus joined Grayson Brulte on The Road to Autonomy podcast to discuss how autonomous trucking is poised to transform local communities, economically, socially, and operationally. In Texas, Plus is actively working to deploy fully autonomous trucks in partnership with International by 2027. As part of the preparation for launch, Earl is meeting with community leaders, elected officials and community colleges in an effort to build transparency and trust with the local communities. When autonomous trucks are deployed, they will make our roads safer and they will have a positive economic benefit on society. The economic benefits of autonomous trucking will be felt in local communities as they will strengthening local businesses through increased spending in local communities.Autonomous trucking isn't just about moving freight, it's about creating opportunity without debt, while revitalizing communities, one route at a time.Episode Chapters0:00 Autonomous Trucking Policy4:20 Economic Impact of Autonomous Trucking5:58 Public Trust10:51 Community Colleges12:28 Impact on Society17:29 California DMV Autonomous Trucking Rulemaking 22:48 Hours of Service 27:57 Building & Maintaining Trust35:21 Autonomous Trucking Industry 40:35 Key Takeaways Recorded on Wednesday, April 30, 2025--------About The Road to AutonomyThe Road to Autonomy provides market intelligence and strategic advisory services to institutional investors and companies, delivering insights needed to stay ahead of emerging trends in the autonomy economy™. To learn more, say hello (at) roadtoautonomy.com.Sign up for This Week in The Autonomy Economy newsletter: https://www.roadtoautonomy.com/autonomy-economy/See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Tuesday on AOA, powered by Cenex, we start the show with a look at this red-hot cattle market with Kyle Bumsted from Allendale. In Segment Two, we look at a new economic impact report commissioned by Clean Fuels Alliance America and get an update on 2026 RVO's with Kate Shenk, Director of Regulatory Affairs for Clean Fuels. In Segment Three, we get an update on the latest trends in the Meat Demand Monitor for April with Glynn Tonsor from Kansas State University. (Find the report here: https://agmanager.info/livestock-meat/meat-demand/monthly-meat-demand-monitor-survey-data) Then, we close the show discussing spring pests and Tick Awareness Week with Dr. Jim Fredericks from the National Pest Management Association.

Send us a textDr. Manfred Stapff, MD, PhD is a physician and pharmaceutical industry leader with over 30 years of experience in internal medicine, clinical research, and drug development, who has worked across a range of therapeutic areas including NASH, CV, CNS, respiratory, oncology, GI, anti-infective, and orphan diseases.Dr. Stapff has held senior roles at Merck & Co., Forest Laboratories (now Allergan), and LG Chem (CMO / COO), specializing in clinical development, regulatory affairs, and global medical operations. As Chief Medical Officer at TriNetX, he helped build the worldʼs largest real-world data (RWD) research network. Dr. Stapff's expertise spans clinical trials, drug development, regulatory affairs, quality management, and real-world studies.As the founder of Candid Advisory (https://candid-advisory.com/), Dr. Stapff helps organizations leverage real-world data and AI to improve healthcare decision-making and regulatory strategies. Dr. Stapff's new book, Real-World Evidence Unveiled: Navigating the Maze of Modern Misinformation ( https://www.amazon.com/Real-World-Evidence-Unveiled-Navigating-Misinformation-ebook/dp/B0F6DWR6MY?ref_=ast_author_mpb ), explores how misinformation shapes science, media, and public health and how we can separate fact from fiction.#RealWorldEvidence #ManfredStapff #ClinicalTrials #RegulatoryAffairs #RealWorldData #DrugRepurposing #RWE #ArtificialIntelligence #FakeNews #MediaBias #Misinformation #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #ViralPodcast #STEM #Innovation #Technology #Science #ResearchSupport the show

Our recent SAM Huddle, Thinking Clearly in Uncertain Times, was recorded on April 21, 2025. With tensions around trade and cross-border relations rising, this conversation brought together industry and policy perspectives to delve into how these developments are reshaping the landscape for travel and resort operations throughout North America. This is episode two of our two-part series covering this conversation.  The J-1 visa program is facing potential cuts, prompting resorts to diversify recruitment strategies. While the program currently remains viable for the upcoming season, H-2B visas are being considered as a more stable—albeit costlier—alternative. Many resorts are preparing to use both to cover seasonal staffing needs.  Plus, efforts to streamline the National Environmental Policy Act or NEPA process are also underway, with more responsibility placed on project sponsors to prepare documentation. Staffing shortages at the federal level are causing some delays, leading to increased use of third-party contractors. But, projects that can align with forest health and wildfire mitigation goals may gain added momentum. Speakers: Dave Byrd, Director of Risk and Regulatory Affairs, NSAA Scott Prior, Senior Associate, Environmental and Permitting, SE Group Nate Riccardi, Pabian Law Listen to part 1 of the conversation here.

In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode. Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS's application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS's international team developing accessible content to support manufacturers with the regulatory pathways and transitions. 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 from the Video Claire Dyson LinkedIn:  Claire Dyson | LinkedIn  Blogs – 3 part series on U vs UK PMS   UK PMS Regulations: Overview & Key Requirements for Medical Device Safety  UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements  UK PMS vs EU MDR – Key Differences & Impact on CE-Marked Medical Devices  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 Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

Today on the Digging in Podcast. Kayden Guymon, MOFB's Director of Regulatory Affairs & Policy Counsel sits down to talk about the "Purple Paint Law" and how landowners can use this law to notify the general public of when they are approaching privately owned land. Subscribe wherever you listen to podcasts to have Digging In sent directly to your smart device each time it's released! Host: Janet Adkison, Missouri Farm Bureau Director of Public Affairs Guest: Kayden Guymon, Missouri Farm Bureau Director of Regulatory Affairs & Policy Counsel Producer: Jacob King, Missouri Farm Bureau Video & Audio Media Specialist

Jaya Tiwari, Senior Vice President of Clinical and Regulatory Affairs at XVIVO, which is focused on improving organ preservation for transplantation. Current organ preservation methods using ice coolers limit the time and distance organs can be transported.  XVIVO's perfusion technology can significantly extend the preservation time of hearts, kidneys, livers, and lungs, providing hospitals and transplant centers access to more viable organs. The company is passionate about increasing organ availability to give more patients access to life-saving transplants. Jaya explains, "I take it back to 1967 when the first heart transplant was performed in Cape Town, and the way that the heart was preserved and transported in essentially an ice box. The standard of care for the preservation of organs is still an ice or an ice cooler with ice. So, this decreases metabolic activities. So, to try to preserve the organs so that you can get them from the donor to the recipient, the problem is that the organs are not viable for a very long time, and they start to degrade very quickly. That really limits the amount of time that the organs can be on ice, transported from the donor to the recipient hospital. Because of that logistical complexity, a lot of organs are ultimately not transplanted." "There have been some preclinical studies that we've done that have shown viability of the heart tissue for up to 24 hours. But what I think is probably the most remarkable example that we've seen is that the universities in Paris have put together something called an investigator-initiated study, where they actually were able to transport a donor heart from the French West Indies to Paris for transplant. That was about 12 hours that the heart was in transport and using the device. So that's remarkable because that essentially tripled the standard preservation time for hearts. Now, in the US, we have a clinical trial where we're currently seeking approval from the FDA that it's safe and effective to use this device for up to 12 hours." #XVIVO #HealthcareInnovation #LifeSavingTechnology #PatientOutcomes #OrganTransplantation #OrganTransplants xvivogroup.com Download the transcript here

Jaya Tiwari, Senior Vice President of Clinical and Regulatory Affairs at XVIVO, which is focused on improving organ preservation for transplantation. Current organ preservation methods using ice coolers limit the time and distance organs can be transported.  XVIVO's perfusion technology can significantly extend the preservation time of hearts, kidneys, livers, and lungs, providing hospitals and transplant centers access to more viable organs. The company is passionate about increasing organ availability to give more patients access to life-saving transplants. Jaya explains, "I take it back to 1967 when the first heart transplant was performed in Cape Town, and the way that the heart was preserved and transported in essentially an ice box. The standard of care for the preservation of organs is still an ice or an ice cooler with ice. So, this decreases metabolic activities. So, to try to preserve the organs so that you can get them from the donor to the recipient, the problem is that the organs are not viable for a very long time, and they start to degrade very quickly. That really limits the amount of time that the organs can be on ice, transported from the donor to the recipient hospital. Because of that logistical complexity, a lot of organs are ultimately not transplanted." "There have been some preclinical studies that we've done that have shown viability of the heart tissue for up to 24 hours. But what I think is probably the most remarkable example that we've seen is that the universities in Paris have put together something called an investigator-initiated study, where they actually were able to transport a donor heart from the French West Indies to Paris for transplant. That was about 12 hours that the heart was in transport and using the device. So that's remarkable because that essentially tripled the standard preservation time for hearts. Now, in the US, we have a clinical trial where we're currently seeking approval from the FDA that it's safe and effective to use this device for up to 12 hours." #XVIVO #HealthcareInnovation #LifeSavingTechnology #PatientOutcomes #OrganTransplantation #OrganTransplants xvivogroup.com Listen to the podcast here

Send us a textDr. Mirza Rahman, MD, MPH serves as the President of the American College of Preventive Medicine ( ACPM - https://www.acpm.org/about-acpm/governance/executive-officers/mirza-rahman/ ), a professional community, founded in 1954 as a professional community for board-certified physicians to network, share their expertise and advocate for the advancement of prevention. Today, ACPM represents over 2,000 physicians, medical students, non-physicians, and other partners. All believe in the importance of preventive medicine in our society. Dr. Rahman also serves as the Senior Vice President, Patient Safety & Pharmacovigilance at Cybin ( https://cybin.com/our-team/ ), a pharmaceutical company seeking to bring novel, second-generation psychedelics to market. He also and is a Co-Founder and President of the Guyanese Diaspora Charity ( https://www.guyanesediasporacharity.org/ ), a 501(c)(3) non-profit organization focused on helping to improve the lives of Guyanese. In addition, Dr. Rahman is an Adjunct Associate Professor of Epidemiology at Columbia University ( https://www.publichealth.columbia.edu/profile/mirza-i-rahman-md ) and as an Adjunct Associate Professor at the University of Guyana.Most recently, Dr. Rahman was the Vice President & Chief Safety Officer at Organon, a global healthcare company. There, he was responsible for leading and setting the broad strategic direction for pharmacovigilance for this multinational company.Prior to that, Dr. Rahman was the Senior Vice President, Chief Global Pharmacovigilance Officer & European Research & Development Lead at Otsuka Pharmaceuticals, a global Japanese based pharmaceutical company. In 2013, he created the ACPM - Otsuka Pharmacovigilance Physician Program in Global Medical Safety. Dr. Rahman joined Otsuka from Merck Research Laboratories, where he was an Executive Director in the Clinical Risk Management/Global Safety department. Before this, he worked at Johnson & Johnson in a variety of positions, serving as a Worldwide Vice President, Health Economics & Reimbursement at Ortho-Clinical Diagnostics in his last role there.During his 25+ years in the pharmaceutical industry, while Dr. Rahman has worked primarily in Pharmacovigilance, he has also worked in Medical Affairs, Medical Information, Health Economics and Outcomes Research, Quality Management, Clinical Development, Manufacturing, and Regulatory Affairs.Dr. Rahman completed his Public Health & General Preventive Medicine Residency along with his Family Medicine Residency at Stony Brook University. He completed the Advanced Management Program at the Columbia Business School and earned his Master of Public Health degree from the Columbia University School of Public Health. Dr. Rahman earned his Doctor of Medicine degree from the Stony Brook University School of Medicine, and his Bachelor of Science degree from the Sophie Davis School of Biomedical Education at the City College of the City University of New York. #MirzaRahman #AmericanCollegeOfPreventiveMedicine #PatientSafety #Pharmacovigilance #GuyaneseDiasporaCharity #Epidemiology #ColumbiaUniversity #UniversityOfGuyana #MedicalAffairs #HealthEconomics #OutcomesResearch #QualityManagement #ClinicalDevelopment #RegulatoryAffairs #PublicHealth #BrainHealth #DiabetesPrevention #ReducingHypertension #LifestyleMedicine #PopulationHealth #ViolencePrevention #Psychedelics #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #Podcasting #ViralPodcast #STEM #Innovation #Science #Technology #ResearchSupport the show

Are Google and Facebook screwed? That's the question which Keith Teare asks in today's That Was The Week tech newsletter. In our age of nationalist globalization, Teare argues, Facebook and Google, the original darlings of the Web 2.0 revolution are, so-to-speak, half-fucked. On the one hand, they are the victims of a legal witch hunt by a nationalist U.S. government intent on punishing Big Tech innovation; on the other, they continue to reap the benefits of an increasingly globalized digital marketplace. No wonder, then, that Lee-Anne Mullholland, the Google VP of Regulatory Affairs, has claimed a kind of Trumpian half-victory in this week's legal ruling against her company. “We won half of this case and we will appeal the other half,” Mullholland wrote. Perhaps. But as Teare drolly remarks in his editorial, “nobody can accuse the Government of being fast.” No, not even half-fast. In this absurdly anachronistic fight against Google and Facebook, the snail-paced U.S. government is actually fighting the war before the last war. The only Big Tech thing that matters in 2025 is artificial intelligence. And retroactively breaking up half-archaic companies like Meta or Google isn't going to make much difference in today's all-important race to control tomorrow's A.I. economy. * Google and Meta (Facebook) are facing significant antitrust challenges. Meta is undergoing a trial questioning the legitimacy of their acquisitions of Instagram and WhatsApp from 2012 and 2014, while Google has been found guilty of maintaining an advertising monopoly.* Both Keith and Andrew discuss how the government's antitrust actions seem to come too late, with Keith describing it as "government overreach" and noting that "Nobody can accuse the government of being fast," calling these cases against actions from a decade ago "shocking."* Keith argues that these companies are facing existential threats from technological shifts, not just legal challenges. He notes that Google's core business of cost-per-click advertising is shrinking both in usage and revenue per click, and faces additional challenges in the AI era where ads don't fit neatly with AI results.* Then there's China. Keith and Andrew discuss about the decline of Western technological dominance and the rise of the Chinese economy, with references to a shift toward "de-globalization" at the political and military level while economic globalization continues.* They discuss the potential future impact of AI on employment and social structures, with Keith noting that the "unknown unknown" is "the impact of AI on employment and abundance," suggesting two possible futures: either a utopia where "nobody needs to work and everyone can eat, live, feed, be entertained" or an "apocalypse where it's a hellscape for anyone that isn't rich."Keen On America is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit keenon.substack.com/subscribe

Summary: At the heart of any successful self-care business is a portfolio of recognizable and trusted consumer health brands. These brands could play a key role in unlocking the potential of digital self-care in the UK, suggests Michelle Riddalls, in this second part of her Over the Counter interview. As PAGB CEO, Michelle has seen first had how the UK consumer health industry has been transformed, for example also by Brexit. Has the UK's exit from the EU realised the promises of innovation unleashed from bureaucracy? Not so far, Michelle reflects, but it might be too soon to tell. What she can predict is that with its new five-year strategy, PAGB will remain dedicated to supporting UK firms in navigating a continuously evolving industry landscape. Timestamps 2:00 – Digital consumer health in the UK 7:00 – The power of brands 12:00 – Brexit, promise realised? 20:00 – What's next for the UK OTC industry? Guest Bio Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King's 2025 New Year Honours.

In this episode, join scientific consultants Lois Haighton, Jayne Stewart, and Luke Gwenter from Intertek's Food & Nutrition Assuris Group as they explore the requirements for filing a Due Diligence Statement under EUDR.  Tune in as they discuss the due diligence statement or DDS, which is one of the 3 necessary conditions for EUDR compliance, in order to import or export relevant products to or from the EU market. Don't miss this informative podcast on navigating compliance in an evolving regulatory landscape!Speaker:Lois Haighton- Senior Director, Toxicology & Project Operations, Food & Nutrition Group, Intertek AssurisJayne Stewart- Scientific Consultant, Regulatory Affairs & Dietary Intakes, Food & Nutrition Group, Intertek AssurisLuke Gwenter- Associate Dietary Intakes, Food & Nutrition Group, Intertek Assuris Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.

OIRA — the Office of Information and Regulatory Affairs — is an obscure, but powerful federal office around the corner from the White House. President Trump has decided that it should get even more powerful.For the last 45 years, OIRA has overseen most federal agencies by reviewing proposed regulations to make sure they agree with the President's policies and don't conflict with the work of other agencies. But one set of federal agencies has always been exempt from this review process — independent federal agencies like the SEC, FTC, FCC, and Federal Reserve. Until now.According to a new executive order, those independent agencies are about to get a lot less independent. We take a look at what this change could mean for financial markets...and the future of American democracy.This episode was produced by James Sneed and Willa Rubin. It was edited by Jess Jiang and engineered by Jimmy Keeley. It was fact-checked by Sierra Juarez. Alex Goldmark is our executive producer.Find more Planet Money: Facebook / Instagram / TikTok / Our weekly Newsletter.Listen free at these links: Apple Podcasts, Spotify, the NPR app or anywhere you get podcasts.Help support Planet Money and hear our bonus episodes by subscribing to Planet Money+ in Apple Podcasts or at plus.npr.org/planetmoney.Music: Universal Music Production - "Tanga," "The Jump Back," and "Kumbatia."Learn more about sponsor message choices: podcastchoices.com/adchoicesNPR Privacy Policy

In this episode of the Almond Byte, the Almond Board of California's Global Technical and Regulatory Affairs team highlights two major regulatory developments shaping almond exports.First, a major milestone for U.S. almond trade with Japan: USDA and Japan's Ministry of Health, Labor & Welfare have signed a voluntary aflatoxin pre-testing protocol. Years in the making, this agreement significantly reduces Japan's inspection frequency for protocol participants, helping streamline exports and reduce costs. The episode discusses how handlers can participate and what to expect from implementation.Then, we shift to the European Union, where the European Commission recently unveiled its “Vision for Agriculture and Food.” In response to last year's farmer protests, the EU is moving toward tighter import controls — emphasizing mirror clauses, food safety, pesticide regulations and sustainability requirements for imported goods.

Just weeks before the summer concert season kicks off, President Trump recently signed an executive order to combat ticket scalping in the live entertainment industry.   Despite efforts from several past presidents and lawmakers to address this issue, ticket scalping continues to be a significant problem. Further, the soaring costs of some tickets have been a major headache for music, theater, and sports fans.   Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, recently spoke with FOX News Rundown host Chris Foster to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry.   Wall also explained how ticket pricing works, who collects the widely hated added fees, and what is being done to combat scalpers and bots.   We often must cut interviews short during the week, but we thought you might like to hear the full interview.   Today on Fox News Rundown Extra, we will share our entire interview with Live Nation's Dan Wall and let you hear more about his take on the live entertainment industry and what can be done to give fans some relief.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Just weeks before the summer concert season kicks off, President Trump recently signed an executive order to combat ticket scalping in the live entertainment industry.   Despite efforts from several past presidents and lawmakers to address this issue, ticket scalping continues to be a significant problem. Further, the soaring costs of some tickets have been a major headache for music, theater, and sports fans.   Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, recently spoke with FOX News Rundown host Chris Foster to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry.   Wall also explained how ticket pricing works, who collects the widely hated added fees, and what is being done to combat scalpers and bots.   We often must cut interviews short during the week, but we thought you might like to hear the full interview.   Today on Fox News Rundown Extra, we will share our entire interview with Live Nation's Dan Wall and let you hear more about his take on the live entertainment industry and what can be done to give fans some relief.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Just weeks before the summer concert season kicks off, President Trump recently signed an executive order to combat ticket scalping in the live entertainment industry.   Despite efforts from several past presidents and lawmakers to address this issue, ticket scalping continues to be a significant problem. Further, the soaring costs of some tickets have been a major headache for music, theater, and sports fans.   Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, recently spoke with FOX News Rundown host Chris Foster to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry.   Wall also explained how ticket pricing works, who collects the widely hated added fees, and what is being done to combat scalpers and bots.   We often must cut interviews short during the week, but we thought you might like to hear the full interview.   Today on Fox News Rundown Extra, we will share our entire interview with Live Nation's Dan Wall and let you hear more about his take on the live entertainment industry and what can be done to give fans some relief.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Join us for our special edition show bringing on guests from reputable organizations and companies based in Canada. As many know, CPG is alive and well in Canada with many brands that are growing in their home country and many entrepreneurs choose to expand to the United States and abroad.We will be bringing on (in no particular order)Sonia Parmar - VP of Reg Affairs & Gov Relations for CHFAJules Gorham - Director of Regulatory Affairs & Policy for CHFASteve Dontigny - Foundry President Megan Silk - Co-Founder of GingerBug Robert Cogan - Owner of Power Full Energy DistributionThis episode is also sponsored by Power Full Energy Distribution.

In this episode of The Med-Tech Talent Lab podcast, host Mitch Robbins interviews Mary McNamara-Cullinane, Vice President of Regulatory Affairs at ClearPoint Neuro, about her 25+ year journey in the medical device regulatory space.Key Highlights:Mary shares her background as the youngest of eight children and how her early work ethic shaped her career pathLearn how Mary transitioned from research to regulatory affairs through roles at Brigham and Women's, CRBARD, and a 17-year consulting careerDiscover what makes an outstanding regulatory professional in today's environmentUnderstand the challenges regulatory executives face when balancing company goals with regulatory requirementsPractical Takeaways:Why proactive research and understanding the "why" behind regulations separates exceptional regulatory professionalsThe importance of managing leadership expectations around FDA timelinesWhy submitting complete FDA submissions is more efficient than rushing deficient onesThoughts on remote work effectiveness in regulatory rolesMary also discusses ClearPoint Neuro's exciting work with gene therapy companies and their recent partnership with PTC Therapeutics to address rare diseases in children.Whether you're a regulatory professional looking to advance your career or an executive trying to better understand the regulatory landscape, this conversation offers valuable insights from a seasoned industry leader.Mary McNamara-Cullinane on LinkedIn: https://www.linkedin.com/in/marymcnamaracullinane/ClearPoint Neuro on the web:https://www.clearpointneuro.com/

On this episode of the Scouting For Growth podcast, Sabine VdL talks to Lisa Bechtold, global executive and strategic leader in technology and law who currently serves at the head of AI governance from a transformative viewpoint at Zurich Insurance Group. In this episode, we explore the challenges and opportunities of the current AI transformation, what it takes to drive innovation in insurance while minimizing potential risks about AI, the role of digital trust and sustainability in leveraging AI for long-term growth, and how leaders can prepare their teams for the digital transformation ahead of us. KEY TAKEAWAYS AI governance is about how we use AI, which already affects all areas of our private and business lives. The acceptance and potential success of AI applications, tools and use cases correlate with the respect of legal systems and the culture of the country or region. With the tools, systems and platforms we’ve built at Zurich, we’ve driven and scaled AI adoption, including the reuse of solutions which have proven extremely successful. In parallel, we drive AI literacy to foster adoption, but also to ensure AI tools are being used in an optimal way. For example, setting the right prompts is crucial for generating the most valuable output from GenAI tools. On one hand, we invest in the education of our workforce, with digital upscaling and AI literacy in particular. On the other hand, it’s crucial to allow for experimentation in a safe sandbox environment so that everyone is embrace the technological opportunities. Insurance has always been a data-driven industry, so the adoption of AI techniques is very well founded in insurance, from risk modelling to all phases of the insurance business value chain. Looking ahead, with the AI revolution taking place this year, both opportunities and risks will be taken to another level. Today,AI systems are beginning to autonomously interact with one another and adapt their behaviours accordingly. I expect, as things increase within both the interaction of individual AI agents as well as in the creation of high-performance, multi-agent systems. Such multi-agent systems bring a multitude of business opportunities but also trigger challenges, such as potential information asymmetries and miscoordination, all of which need to be understood and managed. BEST MOMENTS ‘The goal of deploying AI solutions must be to optimise the benefits of the technology while effectively minimising the risks.’‘AI governance is the foundation of being a catalyst of AI innovation and ensures high-quality outcomes and inspires trust in customers.’‘Today we’re focusing on the scalability and further optimisation of our AI capabilities.’‘Managing the complexity of multi-agent systems in a safe and lean way while optimising business value will be one of the key priorities for 2025.’ ABOUT THE GUEST Lisa Bechtold: As a Global Executive and Strategic Leader and Leader in Technology & Law, I have profound expertise and experience in Data, AI, Governance, Digital Risk and Regulatory Affairs to protect corporate assets and optimise business performance. In my current role as Head of AI Governance at Zurich Insurance Group, I have pioneered and led the operationalisation of a framework for AI Quality & Safety to oversee the development and deployment of AI solutions globally. My multifaceted background positions me perfectly to provide strategic advice on data, digital solutions, and technology topics, integrating legal & risk considerations, to generate sustainable business value and digital trust as a competitive edge. LinkedIn ABOUT THE HOST Sabine is a corporate strategist turned entrepreneur. She is the CEO and Managing Partner of Alchemy Crew a venture lab that accelerates the curation, validation, & commercialization of new tech business models. Sabine is renowned within the insurance sector for building some of the most renowned tech startup accelerators around the world working with over 30 corporate insurers, accelerated over 100 startup ventures. Sabine is the co-editor of the bestseller The INSURTECH Book, a top 50 Women in Tech, a FinTech and InsurTech Influencer, an investor & multi-award winner. Twitter LinkedIn Instagram Facebook TikTok Email Website

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA.  Who is Cyrille Michaud?  Co-founder and managing partner of MD101 Consulting. Consultant in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices. Specialties: Software Processes Management. CE Mark & FDA 510k 21 CFR 820 - ISO 13485 - ISO 14971 - IEC 62304 - IEC 62366 - IEC 60601 - IEC 82304-1 - UL 2900-1 - IEC 81001-5-1 Agile Methods applied to medical device software design. Cybersecurity applied to medical devices. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Cyrille Michaud LinkedIn:  https://www.linkedin.com/in/cyrillemichaud/  MD101 : www.MD101.io  Trainings on Cybersecurity : https://blog.cm-dm.com/pages/Medical-Device-Software-Trainings  Blog post sur cyber et normes : https://blog.cm-dm.com/post/2023/10/06/Final-2023-FDA-Premarket-Cybersecurity-guidance-released  FDA resources on cybersecurity : https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity IG NB checklists : https://www.ig-nb.de/veroeffentlichungen (page in German but download links in the page are in English)  Standard IEC 81001-5-1 and 81001-5-2: https://blog.cm-dm.com/post/2024/10/04/IEC-81001-5-2%3A-AAMI-SW96-cousin-and-IEC-80001-5-1-sister  Blog IEC 81001-5-1: https://blog.cm-dm.com/post/2024/02/23/IEC-81001-5-1-Right-Here-Right-Now 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

President Trump's "Liberation Day," tariffs have been announced, and some Americans fear the results. The Trump administration is sticking to its guns, aiming to see countries come to the table and companies reset their supply chains. President Trump's Department of Government Efficiency continues its pursuit of cutting government waste while slashing money that goes towards diversity, equity, and inclusion grants. Senator Marsha Blackburn (R-TN) joins the Rundown to discuss President Trump's tariffs and his effort to address waste, fraud, and abuse in the federal government. She also relays an important message to the people of Tennessee after devastating storms impact their state.  Last week, President Trump signed an executive order aimed at combating ticket scalping in the live entertainment industry. Despite efforts from several past presidents to reform this issue, ticket scalping continues to be a significant problem. Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, joins to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

Exerting maximum influence on stakeholders, helping companies navigate regulatory complexity and promoting industry best practice are three big jobs that the UK consumer healthcare industry association, PAGB, has set itself for the next five years. In the last five years, PAGB has made significant headway with UK government, reports PAGB CEO Michelle Riddalls, establishing the economic and social value of self-care and ensuring that self-care is part of the UK's national healthcare strategy. Rx-to-OTC switch has been a major area of success, Michelle notes in this episode of the Over the Counter podcast. The Department of Health and Social Care recently published a list of switches it would like to see applications for, and PAGB is now facilitating members to take advantage of this opportunity. But there's always more work to be done. Switch involves significant risk, which PAGB is trying to reduce through further work with policy makers, and with a new government, the association must ensure that self-care remains high up on the agenda for politicians. Given the breadth of PAGB's work discussed by Michelle, we have split this episode into two, so watch out for the second part in two weeks' time on your favourite podcast provider and on Citeline's HBW Insight. Timestamps 2:10 – Introductions 2:40 – PAGB's new five-year strategy 5:40 – Evolution not revolution 8:00 – Self-care and UK government policy 10:30 – Quantifying the value of self-care 12:30 – Lobbying around AMR and OTCs 16:00 – Rx-to-OTC switch in the UK 24:00 – The power of brands Guest Bio Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King's 2025 New Year Honours.

President Trump's "Liberation Day," tariffs have been announced, and some Americans fear the results. The Trump administration is sticking to its guns, aiming to see countries come to the table and companies reset their supply chains. President Trump's Department of Government Efficiency continues its pursuit of cutting government waste while slashing money that goes towards diversity, equity, and inclusion grants. Senator Marsha Blackburn (R-TN) joins the Rundown to discuss President Trump's tariffs and his effort to address waste, fraud, and abuse in the federal government. She also relays an important message to the people of Tennessee after devastating storms impact their state.  Last week, President Trump signed an executive order aimed at combating ticket scalping in the live entertainment industry. Despite efforts from several past presidents to reform this issue, ticket scalping continues to be a significant problem. Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, joins to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

President Trump's "Liberation Day," tariffs have been announced, and some Americans fear the results. The Trump administration is sticking to its guns, aiming to see countries come to the table and companies reset their supply chains. President Trump's Department of Government Efficiency continues its pursuit of cutting government waste while slashing money that goes towards diversity, equity, and inclusion grants. Senator Marsha Blackburn (R-TN) joins the Rundown to discuss President Trump's tariffs and his effort to address waste, fraud, and abuse in the federal government. She also relays an important message to the people of Tennessee after devastating storms impact their state.  Last week, President Trump signed an executive order aimed at combating ticket scalping in the live entertainment industry. Despite efforts from several past presidents to reform this issue, ticket scalping continues to be a significant problem. Dan Wall, the Executive Vice President of Corporate and Regulatory Affairs at Live Nation, joins to explain why his company supports the President's executive order and to debunk myths surrounding scalpers and dynamic pricing in the industry. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman.  Learn more about your ad choices. Visit podcastchoices.com/adchoices

If President Trump's tariff strategy succeeds in sparking a revival in US manufacturing, one consequence will be surging demand for power. We are already seeing electricity demand starting to pick up after 15 years of stagnation, driven by new data centers for AI and a wave of factory-building for semiconductors and batteries that is already under way. How can the electricity industry increase capacity to meet that growing demand and provide the power that the country needs?That's the question for this special episode of the Energy Gang, recorded live in front of an invited audience at the headquarters of the American Clean Power association in Washington DC. Host Ed Crooks talks to Chris Shelton, the Chief Product Officer at AES, Travis Kavulla, the Vice-President for Regulatory Affairs at NRG Energy, and MJ Shiao, the Vice President of Supply Chain and Manufacturing at American Clean Power.They discuss whether electricity demand growth is really happening, which technologies are best placed to provide new supply, and who will end up paying for the investment needed to increase capacity. The Trump administration's focus has been on “baseload” power, particularly new natural gas power plants. But there are reasons why they cannot be a complete solution. Renewable energy and battery storage also have important roles to play.The group also assess the impacts of changing energy policies under a Republican administration and Congress. What will be the fate of tax credits for low-carbon energy under the Inflation Reduction Act? And will moves to expedite permitting and environmental approvals make it easier to build all kinds of new infrastructure, including power and energy facilities, in the US?See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

As the world increasingly moves toward cleaner energy solutions, the demand for long-duration energy storage is at an all-time high. Hydrostor, a global leader in compressed air energy storage, is addressing this challenge by providing scalable, efficient, and sustainable alternatives to traditional battery technology. In this episode of Alternative Power Plays, hosts Alan Seltzer and John Povilaitis speak with Scott Bolton, Executive Vice President of Global Policy and Regulatory Affairs at Hydrostor. They discuss how the company's innovative storage technology is helping to stabilize power grids around the world. Scott explains the mechanics of compressed air energy storage and compares it to lithium-ion batteries and pumped hydro, illustrating why this technology is positioned to play a crucial role in the transition to clean energy.The conversation also highlights Hydrostor's flagship projects—the Silver City Energy Center in Australia and the Willow Rock project in California—showing how these large-scale storage solutions meet various energy market needs. Additionally, Scott addresses the regulatory challenges that Hydrostor faces, discusses how they collaborate with policymakers to facilitate energy storage deployment, and shares insights on the future of energy infrastructure development.To learn more about Hydrostor, visit: https://hydrostor.ca/ To learn more about Scott Bolton, visit: https://www.linkedin.com/in/scott-bolton-72489/To learn more about Alan Seltzer, visit: https://www.bipc.com/alan-seltzer⁠   To learn more about John Povilaitis, visit: ⁠https://www.bipc.com/john-povilaitis

We're excited to welcome Oeystein Kjoersvik to AI Uncovered. Oeystein leads the Generative AI program within the Quality Assurance team at Merck, where he focuses on developing AI tools and applying a quality-first approach to ensure safe, effective use of AI in GxP-regulated environments.In this episode, Tim and Oeystein delve into the challenges of adopting AI in regulated settings, the complexity of validating GenAI tools, and the transition from traditional processes to AI-augmented systems. They also explore Oeystein's work with the IMPALA Consortium and the importance of cross-industry collaboration to identify and scale high-value use cases for Generative AI.Before his current role, Oeystein served as a Product Owner in Analytics at Merck IT, building analytics platforms and integrating data science across systems. He also contributed as a Machine Learning Subject Matter Expert to TransCelerate's Intelligent Automation Group, advancing AI applications in pharmacovigilance.Oeystein brings a rare blend of technical expertise and regulatory insight. He's passionate about helping teams adopt AI responsibly and transparently—ensuring innovation aligns with quality across the pharmaceutical landscape.Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

In episode 74 of Revamping Retirement, hosts Jennifer Doss and Pete Ruffel discuss governmental affairs with Scott Eckel, Managing Director of Legislative and Regulatory Affairs at Charles Schwab. Scott discusses his role as a lobbyist and they cover key issues such as financial regulations, e-delivery of documents, and the new administration's potential impact on tax reform and retirement policies. Scott also touches on the budget reconciliation process and its implications.

Join us for an insightful episode of Seen & Herd as we welcome back Paul Sousa, Western United Dairies' Director of Environmental Sustainability and Regulatory Affairs. Paul dives into the latest regulatory updates, including recent changes to CARB's air quality rules, ongoing water quality discussions, and what dairy producers should prepare for in the coming years. Plus, we highlight the upcoming California Dairy Sustainability Summit and why it's a must-attend event for the industry.Tune in to stay informed, and don't forget to check the links in the show notes for more details, including access to past episodes and registration info for the summit.> Click HERE to hear Paul's previous update.> Click HERE to read WUD's SWRCB Dairy Order Comments> Click HERE to learn more about the Dairy Sustainability Summit

In this episode, Harriet Edwards from Boyds hosts a discussion on 2025 predictions in drug development and regulatory affairs. Joined by regulatory experts Dr. Katherine Bowen and Dr. Eric Harder, the conversation covers the anticipated trends in the realm of cell and gene therapy, rare diseases, and the increasing role of artificial intelligence (AI). As we look ahead to 2025, Boyds' regulatory experts discuss the evolving regulatory landscape, legislative changes in the US and EU, and the importance of patient-centric approaches. Join us for this insightful journey as we uncover what 2025 has in store for drug development and regulatory strategies. 

With the latest VAT increase, South Africa is set to lose R29 billion in excise tax revenue a year. In this interview, Johnny Moloto, the Sub-Saharan Head of Corporate and Regulatory Affairs of  British American Tobacco (BAT), describes how the illicit cigarette trade exploded during the 2020 COVID-19 tobacco sales ban - and now accounts for 75 percent of the total cigarette market. He says the industry still has not seen the effects of the dismantlement of an illicit gold and tobacco network announced by President Cyril Ramaphosa in his recent SONA speech. “It took us all by surprise…We would like to hear more about which syndicate that was,” he says. As for persistent rumours that the cigarette barons have friends in high places, he says: “Why is it always the usual suspects that are always being picked up by … research? Maybe we ought to look into this, if only to satisfy our curiosity and put this matter to bed so that there isn't this speculation about the complicity of politicians as well as government authorities.” Moloto lists proposed solutions to combat this arm of organised crime more effectively.

March's Almond Byte brings you the latest insights from the Almond Board of California's Global Technical and Regulatory Affairs team. This month, ABC made waves at Gulfood 2025, connecting with key buyers and exploring future opportunities in Dubai's expanding trade landscape. Meanwhile, new tariffs on Chinese imports are impacting the global almond market, with retaliatory duties adding more challenges for exporters. On the opportunity front, Morocco's booming almond demand is creating exciting prospects for U.S. growers, while an upcoming exploratory trip to Turkey aims to strengthen ties with major processors. Stay tuned for more details on these industry-shaping developments.

SymPhysis Medical, the Galway MedTech company seeking to address the distressing condition of fluid in the chest in cancer patients, has announced a significantly strengthened senior team and plans for rapid growth as it prepares for its device's US launch. With clearance from the US Food and Drug Administration (FDA) targeted by 2026, SymPhysis Medical aims to launch its device within the next 18 months and to reach €40M in revenue by 2030. Founded by CEO Tim Jones and Chief Scientific Officer, Dr Michelle Tierney, SymPhysis Medical has developed a device, releazeTM, which can be used by cancer patients who are receiving palliative care to relieve the symptoms of fluid in the chest. These symptoms include shortness of breath, discomfort and pain. The condition, experienced by approximately 50% of late-stage cancer patients, limits movements and activities, while necessitating regular medical appointments at a time when many wish to be at home and spending time with loved ones. The company founders expect their device's launch in the US to mark a transformation in the care, and quality of care, of these patients. In the most recent funding round, SymPhysis Medical has raised €2.8M and expects to close a further €3.7M from a combination of current and new investors by April 2025. Investors have been impressed by SymPhysis Medical's ambitious growth plans and focus on a market, worth €860M in the US and Europe alone, which has lacked innovation over the last 25 years. The company was endorsed by the European Innovation Council (EIC) in February 2025, receiving the Seal of Excellence, which highlights the value and impact of the innovation. SymPhysis Medical expects to represent 20% of the US market by 2030 and 10% of the European market in the same period. This will mean that 35,000 patients could be benefiting from releazeTM by 2030. Driving SymPhysis Medical's post-launch growth and momentum will be an enhanced senior team whose track record covers some of the world's largest MedTech and life sciences companies. Their expertise includes sales and distribution of medical devices, business strategy and regulatory affairs. Joe Villanova, VP Sales and Marketing, will drive SymPhysis Medical's penetration of the US market. He has more than 35 years of experience in commercialising medical devices, with 15 years of experience in those addressing fluid in the chest. He has held leadership roles in multinationals including Baxter Healthcare and Becton Dickinson. Meanwhile, Niamh St John Lynch, Director of Quality Assurance and Regulatory Affairs, has 30 years of international experience in the pharmaceutical and medical device industries. Her knowledge of medical device regulations, FDA clearance and risk management, through previous work with Johnson & Johnson and Boston Scientific, among others, will help to drive global regulatory approval and adoption of releazeTM. The team will also benefit from a strengthened board of directors. David Uffer has almost 35 years of experience in the life sciences industry. His experience has seen him lead business development for multinationals including Boston Scientific, Abbott and Medtronic. With extensive experience in the commercialisation and launch of early stage medical device companies, he will be pivotal to SymPhysis Medical's launch and success in the US. Meanwhile, Gerard Ryan is a serial entrepreneur and experienced investor. Gerard founded Longboat Clinical (sold to Advarra in 2020 in a multimillion Euro deal) and Firecrest (sold in 2011 to ICON plc for €50M). One of SymPhysis Medical's first investors, Ryan will help to drive SymPhysis Medical's strategic direction. Tim Jones, CEO, SymPhysis Medical, said: "This is an exciting time for our company. For six years, we have been laser-focused on our mission to help late-stage cancer patients - and, indirectly, their loved ones - to ease a very distressing condition at an extremely difficult time for them. I am immensely proud of our...

Athena GTX has been at the forefront of innovative medical technology since its founding in 2003, originally developing solutions for military applications. Today, the company serves a diverse range of industries, bringing cutting-edge patient monitoring systems to high-risk environments. Sean Mahoney, VP of Engineering and Regulatory Affairs, joins us to share an exclusive look at Athena GTX's newest product and the complex journey of bringing it to market. With stringent FDA regulations and a responsibility to safeguard personal health data, Athena GTX operates within one of the most challenging regulatory landscapes in med-tech. In this episode, Sean walks us through the rigorous development process, from prototype to commercialization, and how Athena GTX ensures compliance without stifling innovation. We explore the future of wearable medical technology, the intersection of military and civilian healthcare applications, and the company's role in shaping next-generation patient monitoring. Whether you're in healthcare, technology, or manufacturing, this conversation provides valuable insights into navigating regulatory challenges while driving innovation forward. Hear the full show: https://iowapodcast.com/sean-mahoney-athena-GTX    

THE TIM JONES AND CHRIS ARPS SHOW 0:00 SEG 1 Speaker’s Stump Speech is brought to you by https://www.hansenstree.com/ Congressman Eric Burlison Representing Missouri's 7th | TOPIC: Introducing the Ending the Cycle of Dependency Act of 2025 to restore integrity to America’s welfare system | Trump’s speech last night | the first hearings of the Subcommittee on Economic Growth, Energy Policy, and Regulatory Affairs. Eric is the Chairman. | Bill Clinton and Al Gore once recommended abolishing the ATF | Continuing resolution | “I trust Trump to do what he says” https://burlison.house.gov/ https://x.com/RepEricBurlison 19:19 SEG 2 Rep. Louis Riggs, 5th District State Representative | TOPIC: The Ukrainian war and the money the U.S. has sent the country | Federal spending and Trump's work to root out waste | Missouri's state budget | Riggs is a member of the Budget Committee https://x.com/riggs4missouri 35:33 SEG 3 Al Green planned his ruckus way ahead of time https://newstalkstl.com/ FOLLOW TIM - https://twitter.com/SpeakerTimJones FOLLOW CHRIS - https://twitter.com/chris_arps 24/7 LIVESTREAM - http://bit.ly/NEWSTALKSTLSTREAMS RUMBLE - https://rumble.com/NewsTalkSTL See omnystudio.com/listener for privacy information.

THE TIM JONES AND CHRIS ARPS SHOW 03.05.2025 Congressman Eric Burlison Representing Missouri's 7th | TOPIC: Introducing the Ending the Cycle of Dependency Act of 2025 to restore integrity to America’s welfare system | Trump’s speech last night | the first hearings of the Subcommittee on Economic Growth, Energy Policy, and Regulatory Affairs. Eric is the Chairman. | Bill Clinton and Al Gore once recommended abolishing the ATF | 7:21 Chris asks about the Continuing Resolution | Eric: “I trust Trump. He hasn't let me down yet. He's a man of his word.” https://burlison.house.gov/ https://x.com/RepEricBurlison https://newstalkstl.com/ FOLLOW TIM - https://twitter.com/SpeakerTimJones FOLLOW CHRIS - https://twitter.com/chris_arps 24/7 LIVESTREAM - http://bit.ly/NEWSTALKSTLSTREAMS RUMBLE - https://rumble.com/NewsTalkSTL See omnystudio.com/listener for privacy information.

Nicholas Capman of The FDA Group welcomes David Festa, Director of Corporate Quality at Thermo Fisher Scientific, to explore whether pharmaceutical and medical device companies are auditing suppliers too frequently and with the right personnel.With over 25 years of experience in quality management and oversight of tens of thousands of suppliers, David advocates for a more strategic approach that balances quality, compliance, and business needs through "exception-based" auditing.Rather than rigidly adhering to calendar-based audit schedules, David suggests companies should assess suppliers based on performance metrics, risk factors, and the criticality of materials they provide. He challenges the industry norm that every supplier must be visited at predetermined intervals, arguing that well-performing suppliers with stable processes may not require frequent on-site visits.David emphasizes the importance of matching auditor expertise with supplier categories. For example, an auditor with deep knowledge of plastics manufacturing will provide far more valuable insights when evaluating a plastics supplier than someone familiar only with general standards. This targeted approach has helped Thermo Fisher predict quality issues and decrease the percentage of poor-performing suppliers.The conversation explores how post-pandemic practices have evolved, with companies developing more harmonized approaches to global auditing and implementing centralized audit portals. David also introduces the concept of a "supplier pricing index" that quantifies the true cost of poor quality, providing a more accurate picture of supplier value than piece price alone.While ISO certifications provide a foundation for quality systems, David cautions against over-reliance on certifications or imposing unnecessary standards on suppliers. The most effective approach focuses on whether suppliers can maintain control of their manufacturing processes and consistently deliver quality products, regardless of certification status.For companies looking to optimize their supplier quality programs, the key is putting the right people in the right places, implementing quantifiable metrics, and taking a holistic view that integrates quality with other business functions.____The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit: ⁠⁠⁠⁠⁠⁠thefdagroup.com⁠⁠⁠⁠⁠⁠.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. J&J is currently involved in a legal battle with Samsung Bioepis, alleging unlawful sublicensing of a Stelara biosimilar. Meanwhile, Takeda has made a significant investment in a new BridGene partnership aimed at targeting undruggable targets. In other news, Regeneron has made strides in developing a gene therapy that can restore hearing in patients with rare genetic deafness. However, Deerfield Management claims that Alcon is hindering Aurion Biotech's IPO progress. Additionally, Trilink is offering mRNA designs that ensure reliable performance across various applications. There have also been reports of compounders suing the FDA, Reperio Therapeutics downsizing their staff, and discussions on how to support small molecule innovations in the industry. And if you missed it, recent developments include Trump threatening big pharma with tariffs, the FDA rehiring scientists, and advancements in pain treatment, RNA editing, and gene therapies being highlighted. Opportunities in neuroscience sales, regulatory affairs, and marketing are currently available for those interested. Thank you for tuning in to Pharma and Biotech Daily for the latest updates in the industry.

Dean's Chat hosts, Drs. Jensen and Richey, welcome Dr. Gerit D. Mulder to the podcast!  Dr. Mulder gave Dr. Jensen an opportunity to join his practice at the Wound Healing Institute after residency, providing a tremendous foundation for future research that included the National Institutes of Health, and Department of Defense opportunities.  Dr. Mulder has a storied history in podiatric medical research in the wound care space.  He received his BS at University of Redlands; a masters degree from Cal State - San Bernadino, then received his DPM from the College of Podiatric Medicine. He received his PhD from Chulalongkorn University through University of California San Diego specializing in Biomedical Sciences/Stem Cells.  Gerit speaks 5 languages and has taught wound care, and implemented wound care programs around the world.  Tune in for a fabulous interview! Below is a brief history of Dr. Mulder's activities and qualifications: • Extensive expertise in the development, implementation and management of clinical trials, clinical operations and teams.  Experience as a lead Principal Investigator interacting with and guiding multicenter trials.  Direct interaction with the FDA, Pharmaceutical Industry and Academic Research Centers.  Focus on Inflammatory Diseases, Dermatology and Infectious Disease.  • Responsible for development and oversight than 120 clinical trials. • Supervised, educated, and guided research teams globally. • Developed project budgets, protocols, guidelines, and implementation plans for developing wound clinics. • Provided strategic and tactical input to the medical industry related to clinical trials with emphasis on Phase 1,2 and 3 studies.  • Created tissue and wound repair programs to increase product understanding to assist Emerging Markets. Additional Expertise and Affiliations Include: • Understanding of Regulatory Affairs. • International experience with monitoring and overseeing clinical trials. • Served as a national and international  • Provided input on new product development for novel disease states.  • Conversational skills in English, Spanish, Italian, French, and German • Extensive experience with KOLs and medical advisory boards. Physician at Christus St. Vincent Medical Center, Wound & Hyperbaric Center. December 2021 to current. • Provide advanced clinical care for chronic wounds of all etiologies including diabetic, venous, pressure, trauma and other wounds. • Direct wound and tissue repair and regeneration research Medical Research Consultant – Independent 2019 – current Clinical Tissue Repair and Regeneration Specialist – 2019-current • Consult internationally on Phase 1,2, and 3 clinical trials • Provide input for development and implementation of clinical trials and educational materials for health care providers related to phase 1, 2 and 3 studies as well as approved products. • Provide clinical care to patients with acute and chronic wounds of all etiologies Director, Professor of Surgery and Orthopedics University of California San Diego Medical Center, Wound Treatment and Research Center   April 1998- December 2013 •  Provided clinical and surgical care, conducted medical student, resident and staff education, oversaw clinical research.  Treated more than 3000 patients per year.  Published in peer reviewed medical journals and key presenter at medical conferences globally. • Oversaw research within my division of the Department of Trauma, with focus on tissue regeneration and repair, inflammatory and infectious related diseases and cell regeneration. June 1986-April 1998: President of WCI (Wound Consultants Inc., previously Wound Healing Institute)    WCI offered consulting services to the biotechnology and pharmaceutical industry related to clinical protocols and trials, implementation of related patient care, planning and managing medical education.  Advised on development of new products related to tissue regeneration and repair. Patient Care    Vice President of Marketing and Medical Affairs DermaRx  May 1995- March 1998 Vice President of Clinical and Regulatory Affairs Organogenesis, Inc.   May 1994-May 1995     Wound Clinic Director Veterans Administration Hospital Denver June 1983- Jne 1992 FDA Experience: • Participated as an advisor to the FDA and companies working with the FDA • Completed and submitted 510k for hydrogel, foam, and other wound treatment devices • Completed clinical section of PMA submission on Apligraf for Organogenesis • Consulted as wound care expert on panels for medical and pharmaceutical industry. • Chaired Human Subjects Committee in Denver for two years for a major IRB. • Interacted with FDA on Dermatology and Inflammatory Diesease Dr. Mulder can be reached at (619) 417-9249 or at gerit.mulder@gmail.com;  gerit.mulder@stvin.org  or on LinkedIn at http://www.linkedin.com/pub/gerit-mulder/a/321/6b5

In today's episode Earl Adams, vice president of Public Policy & Regulatory Affairs at Plus joins us to give us an update on autonomous vehicle and transportation regulations. We'll dive into what to expect with a new administration and what that means for their regulatory priorities. Before coming to Plus, Adams was the former Chief Counsel then Deputy Administrator of the FMCSA. Follow the Loaded and Rolling Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices

In today's episode Earl Adams, vice president of Public Policy & Regulatory Affairs at Plus joins us to give us an update on autonomous vehicle and transportation regulations. We'll dive into what to expect with a new administration and what that means for their regulatory priorities. Before coming to Plus, Adams was the former Chief Counsel then Deputy Administrator of the FMCSA. Follow the Loaded and Rolling Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of the Syneos Health Podcast, series host Dr. Wael Harb, Vice President of Medical Management at Syneos Health, continues the exploration of FDA's groundbreaking Project Optimus and its profound implications for oncology drug development. He is joined by Zohra Lomri, Executive Director, Regulatory Affairs at Syneos Health, to discuss how this initiative is transforming dose optimization strategies and reshaping the clinical trial landscape.The conversation delves into the FDA's emphasis on balancing efficacy and tolerability, the shift away from maximum tolerated doses, and the integration of patient-reported outcomes. Zohra provides valuable insights on the regulatory expectations for dose-ranging studies, the importance of leveraging non-clinical data, and the role of pharmacokinetics (PK) and pharmacodynamics (PD) modeling in optimizing trial designs.Whether you're in oncology drug development or interested in regulatory innovation, this episode offers actionable advice and a glimpse into the future of patient-focused drug development.The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you'll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at insightshub.health. Like what you're hearing? Be sure to rate and review us! We want to hear from you! If there's a topic you'd like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Join us for an in-depth discussion with three different perspectives on the future of energy. We'll explore the potential impacts of Trump's policies on renewable energy, fossil fuels, and the environment. With the Inflation Reduction Act (IRA) driving historic clean energy investments, we're at a critical juncture as Trump begins his second term. Tune in as we navigate the complex landscape of the energy industry's future.The solar industry has proven its resilience time and again. During Trump's first term, solar capacity in the U.S. surged by 128%, exceeding 100 GW despite a federal focus on fossil fuels, according to SEIA. That same spirit of adaptation is palpable today, as the clean energy sector braces for a second term marked by deregulation, energy “trade-offs,” and a growing corporate appetite for renewables. David Roberts, respected journalist and progenitor of Volts.wtf, explores the unpredictability of the Trump's energy policies and how coalitions have become a vital counterbalance to federal uncertainty. Travis Kavulla, Vice President of Regulatory Affairs at NRG Energy, provides a detailed look at regulatory developments, including the potential impact of Chris Wright's leadership at DOE and how the Federal Energy Regulatory Commission's (FERC) evolving role could shape market dynamics.Aaron Nichols, Marketing and Advocacy Specialist at Exact Solar, scoured dozens of articles on the subject and reflects on how Trump's initial term unexpectedly mobilized the solar industry, sparking collaboration that continues to fuel growth. Despite the challenges, there are significant opportunities. Corporate renewable investments, driven by the AI boom and energy-hungry data centers, are reshaping market demand. Industry coalitions are demonstrating the power of collective advocacy in influencing policy and preserving growth. Federal agencies like FERC and DOE are at the forefront of decisions that could redefine the balance between fossil fuels and clean energy. The solar sector is once again proving its resilience, channeling innovation and determination to meet the moment.With Inauguration Day just around the corner, the direction of U.S. energy policy hangs in the balance. Will deregulation spur clean energy growth, or will shifting priorities pose new challenges? Tune in to find out more.If you want to connect with today's guest, you'll find links to his contact info in the show notes on the blog at https://mysuncast.com/suncast-episodes/.Our Platinum Presenting Sponsor for SunCast is CPS America!SunCast is proudly supported by Trina Solar.You can learn more about all the sponsors who help make this show free for you at www.mysuncast.com/sponsors.Remember, you can always find resources, learn more about today's guest and explore recommendations, book links, and more than 730 other founder stories and startup advice at www.mysuncast.com.Subscribe to Valence, our weekly LinkedIn Newsletter, and learn the elements of compelling storytelling:

This week's episode of Parsing Immigration Policy highlights the pivotal role regulations and litigation will play in shaping U.S. immigration policy under the Trump administration. The episode features Elizabeth Jacobs, the Center's Director of Regulatory Affairs and Policy, who talks through the top immigration regulatory moves and legal battles likely to occur during the Trump […]