Shows
The Pharmacovigilance PodcastEU Pharmacovigilance Regulation 2025/1466: Key Changes ExplainedThis episode covers the most important updates introduced in the new EU Implementing Regulation 2025/1466. We look at changes in PV audits, subcontractor responsibilities, Eudravigilance monitoring, and the end of the signal detection pilot for MAHs. A quick, clear breakdown of what matters and what to do next.Link: Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the CouncilQ&A: Q...2025-08-0512 min
Regulatory Affairs & Life ScienceLocal pharmacovigilance: all requirements, how to be compliantWelcome to a new episode of the Di Renzo Regulatory Affairs podcast, where we explore key topics from the world of pharmaceutical regulatory affairs — with clarity, professionalism, and a practical approach.Today, we’re focusing on a crucial subject for all Marketing Authorisation Holders: Local Pharmacovigilance.It’s a vital system to ensure patient safety and regulatory compliance — often underestimated, but absolutely essential across the European landscape.What does it take to set up an effective local pharmacovigilance network? What are the specific responsibilities of Marketing Authorisation Holders?And how can an e...2025-07-2507 min
BioSpaceUnderstanding the FDA's AI Guidance in PharmacovigilanceIn this episode of Denatured, Archana Hegde from IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they navigate the FDA's first draft guidance for AI in drug development, published in January 2025. Hegde explains that the vagueness of the current framework is like “a recipe with no pictures and mystery ingredients." During the discussion, she highlights areas of existing confusion.This episode is presented in partnership with IQVIA.HostLori Ellis, Head of Insights, BioSpaceGuestArchana Hegde, Senior Director, PV Systems...2025-07-0124 min
Drug Safety Matters#38 Patient perspectives in PV: a fireside chat at the ISoP mid-year symposiumThis special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was Improving information capture for safer use of medicines. The episode is an abridged recording of the concluding fireside chat, where Angela Caro Rojas (president of ISoP), Linda Härmark (director of the Drug Safety Research Unit in the UK), Ghita Benabdallah (national pharmacovigilance centre of Morocco, member of the IsoP advisory board), and Daniele Sartori (senior pharmacovigilance researcher at Uppsala Monitoring Centre), discuss patient eng...2025-06-1934 min
Driving the Business of SciencePharmacovigilance Compliance for Small and Mid-sized SponsorsIn this episode of Driving the Business of Science, Keith Parent, CEO of Court Square Group discusses pharmacovigilance compliance for small and mid-sized sponsors with Betty Cory, President of Regxia. Betty explains that pharmacovigilance monitors drug safety in real-world use, often revealing unforeseen adverse effects. Small companies struggle with managing vast amounts of data, necessitating electronic systems. Betty emphasizes the importance of finding partners who understand small businesses' needs and can provide tailored solutions. Court Square Group's platform, RegDocs365™, is highlighted as a fit-for-purpose solution. Betty also shares her background and the philosophy of Regxia, which focuses on...2025-06-1720 min
PharmaLex TalksChallenges and best practices for managing local pharmacovigilance activitiesIn this episode of the PharmaLex Talks Podcast, sits down with Alex Brenchat, Vice President of Local Affiliate Pharmacovigilance Services at PharmaLex, a Cencora company. Together, they explore the complexities of pharmacovigilance (PV) in a global context, focusing on the unique challenges faced by local affiliates in navigating diverse regulations post-marketing. With over 20 years of experience in the pharmaceutical industry, Alex shares valuable insights on balancing local requirements with global standards, the resource-intensive nature of PV activities, and effective strategies for outsourcing these critical functions. Listeners will gain a deeper understanding of the importance of local expertise, streamlined processes, and...2025-05-0912 min
From Concept to Medicine - A Comprehensive Drug Development Journey108 – Role of Pharmacovigilance (S8E3)This episode defines pharmacovigilance and explains its critical role in monitoring drug safety after a medication has been approved and is on the market. We delve into the core activities of pharmacovigilance, which include adverse event detection, assessment, understanding, and prevention. The conversation highlights the ongoing nature of safety monitoring, emphasizing that it doesn't end with a drug's approval.Real-world case examples are used to illustrate how potential safety concerns are identified and managed. The discussion covers the difference between observations in clinical trials and real world environments. We discuss the interactions between different medicines, with food...2025-05-0426 min
Progress, Potential, and Possibilities Podcast / ShowDr. Mirza Rahman, MD, MPH - President, American College of Preventive Medicine - The Power Of PreventionSend 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 p...2025-04-261h 07
Regulatory Affairs & Life SciencePharmacovigilance Responsibility: Who Watches Over Our Medicines?Welcome to a new episode of Regulatory Affairs & Life Science, your go-to space for deep dives into the pharmaceutical world—where regulations, innovation, and public health protection meet. Today, we’re tackling a crucial and complex topic: responsibility in pharmacovigilance.Who is truly accountable for the safety of medicines once they’re on the market? What are the roles of pharmaceutical companies, Qualified Persons for Pharmacovigilance (QPPVs), and regulatory authorities?Starting from an insightful analysis by Di Renzo Regulatory Affairs, we’ll explore how the concept of responsibility in pharmacovigilance has evolved—from Europ...2025-04-0706 min
Intro to Clinical ResearchEpisode 41 - PharmacovigilancePharmacovigilance is a big work that we’re going to break down in this episode, to look at the data around safety events, or patient experienced side effects in clinical trials and after a drug is on the market. Where does the data come from, and what is done with it. We are going to dive into the WHO definition of pharmacovigilance, and look out for a special appearance from our favourite shiny rock!
Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments fo...2025-03-3155 min
This Week in PharmacyPharmacists leading in Pharmacovigilance & Hormone Therapies | TWIRxIn this powerful episode of This Week in Pharmacy, TWIRx we're spotlighting the critical leadership roles pharmacists are taking in two vital areas of patient care: pharmacovigilance and hormone treatment therapies.
🧬 Featured Guest #1: Dr. Sara Rogers, PharmD
A trailblazing researcher and healthcare leader, Dr. Sara Rogers is the founder of the American Society of Pharmacovigilance, a national biomedical and healthcare network committed to improving drug safety. She shares her passion for translating genomics into improved patient care and dives deep into the growing importance of pharmacovigilance in modern healthcare. With adverse drug events contributing to over $136 billion in annual heal...2025-03-2942 min
Pharmacy Podcast NetworkPharmacists leading in Pharmacovigilance & Hormone Therapies | TWIRxIn this powerful episode of This Week in Pharmacy, TWIRx we're spotlighting the critical leadership roles pharmacists are taking in two vital areas of patient care: pharmacovigilance and hormone treatment therapies.
🧬 Featured Guest #1: Dr. Sara Rogers, PharmD
A trailblazing researcher and healthcare leader, Dr. Sara Rogers is the founder of the American Society of Pharmacovigilance, a national biomedical and healthcare network committed to improving drug safety. She shares her passion for translating genomics into improved patient care and dives deep into the growing importance of pharmacovigilance in modern healthcare. With adverse drug events contributing to over $136 billion in annual heal...2025-03-2942 minDrug Safety Matters#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara VidlinThere are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patients and healthcare professionals to make informed decisions.The Research section at Uppsala Monitoring Centre has a team that is currently focussing their efforts on pregnancy-related pharmacovigilance (PV). In this episode, data scientists Sara Vidlin and Levente Papai, and senior pharmacovigilance...2025-03-2736 min
Cannabinoid and Psychedelic Pharmacology and Drug Development30 Day FDA Drug Development in Cannabinoid and Psychedelic Spaces - Day 23 Pharmacovigilance and Post-Marketing SurveillanceThis podcast episode explores pharmacovigilance and post-market surveillance in cannabinoid and psychedelic therapies. The discussion covers how the FDA monitors drug safety after approval, the importance of real-world data collection, and the role of Risk Evaluation and Mitigation Strategies (REMS) in ensuring patient safety. The speakers examine unique challenges in monitoring these therapies, including drug interactions, subjective effects, and the importance of set and setting. They also discuss how technology and collaborative efforts between healthcare providers, researchers, and patients contribute to building a comprehensive safety framework for these emerging treatments.2025-01-3123 minDrug Safety Matters#35 Veterinary pharmacovigilance, part 2 – James MountHuman and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous animal species that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. Tune in to find outHow the types of ADRs reported for animals and h...2025-01-2841 min
The Pharmacovigilance PodcastA New Era For Drug SafetyIn episode #4 of The Pharmacovigilance Podcast, titled “ A
New Era for Drug Safety”, we explore the impact of artificial intelligence AI on drug safety. From automating routine processes like case processing and literature monitoring to enhance advanced analyses such as signal detection
and risk assessment, AI is reshaping the field of pharmacovigilance.
We also delve into critical topics like AI governance and regulatory compliance (including the EU AI Act), highlighting that combi ning AI with human expertise can deliver optimal results.
Discover the specific AI tools and platforms to gain
insights into t...2024-12-2517 minDrug Safety Matters#34 Veterinary pharmacovigilance, part 1 – James MountHuman and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. Tune in to find out:What are the similarities and differences between ve...2024-12-1747 min
The Good Bot: Artificial Intelligence, Health Care, and the LawAI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology ProgramJoin Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law.In this installment of The Good Bot, host Brett Mason is joined by Partner Judy O'Grady and Associate Kyle Dolinsky to discuss the FDA’s new Emerging Drug Safety Technology Program (EDSTP) and how this program encourages the use of AI to improve the efficient collection, processing, and evaluation of single and aggregate patient safety data. They further discuss how the use of AI technologies is expected to reduce costs associated with pharmacovigilance in the fu...2024-12-1122 min
The Pharmacovigilance PodcastRoadmap to Regulatory Excellence in PharmacovigilanceRoadmap to Regulatory Excellence in Pharmacovigilance – Episode 3
Are you ready to take the next step in mastering regulatory intelligence for pharmacovigilance? This episode of Roadmap to Regulatory Excellence in Pharmacovigilance focuses on what makes an effective and future-ready pharmacovigilance system.
This episode discusses the book Pharmacovigilance Regulatory Intelligence: A Journey from Strategy to AI-Powered Implementation by Julia Appelskog. We explore key themes, including why pharmacovigilance is more than just compliance—it’s about protecting patients, building trust, and ensuring systems are equipped to handle the ever-changing pharmaceutical landscape.
We’ll also discuss practical strategies...2024-12-0330 min
The Pharmacovigilance PodcastThe AI Act: What It Means for PharmacovigilanceIn this 1st episode of The Pharmacovigilance Podcast, we examine the groundbreaking AI Act (Regulation (EU) 2024/ 1689), a European Union regulation designed to establish a comprehensive framework for the governance of AI systems.
The AI Act categorizes AI systems into two key groups: high-risk systems and general-purpose AI models. We’ll discuss how these categories are defined and explore the stringent requirements imposed on high-risk AI systems, such as those used in healthcare, including pharmacovigilance processes.
We’ll also examine the special rules for general-purpose AI models, subject to transparency and accountability requirements. Focusing on managing syst...2024-11-2615 minDrug Safety Matters#32 Pharmacovigilance in older adults – Giovanni FurlanMedication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan, Worldwide Safety Site Lead for Thessaloniki of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poor representation and using age alone to define older adults exacerbates this problem, and suggests ways forward in monitoring drug safety in older patients. Tune in to find out:What makes older adults especially at risk of experiencing adverse drug reactions and medication errorsWhy f...2024-10-2547 min
Voices of PharmaAI Meets Pharmacovigilance: Discover Sridivya's Startup Story | #E22-Voices of Pharma | Pharma NowIn this episode, we’re joined by Ms. Sridivya Palacharla, the Founder of SafeVig Solutions, who shares her inspiring journey from a successful career in clinical research to founding her own pharmacovigilance startup.
Ms. Sridivya dives into the essential role that drug safety monitoring plays in safeguarding patients, and how SafeVig Solutions is at the forefront of integrating AI and machine learning to revolutionize pharmacovigilance practices. In addition to her work in pharmacovigilance, Sridivya also speaks about her dedication to empowering women entrepreneurs, especially in rural areas, providing them with opportunities for growth and success.
2024-10-1114 minDrug Safety Matters#31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele SartoriDisproportionality analyses are a mainstay of pharmacovigilance research, but without clear guidelines, they often lead to confusion and misinterpretation. Enter the READUS-PV statement: the first-ever guide for reporting disproportionality analyses that are replicable, reliable, and reproducible. Tune in to find out: The history of reporting guidelines in pharmacovigilance and why the READUS-PV guidelines were created Why there has been a spike in the publication of disproportionality analyses in recent years and what this means for their reliability What it means to publish “good” pharmacovigilance science Want to know more? Re...2024-09-3042 minDrug Safety MattersUppsala Reports Long Reads – Weeding out duplicates to better detect side effectsDuplicate reports are a big problem when it comes to signal detection, but with the help of machine learning and new ways of comparing reports, we may more effectively detect them. This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.After the read, we speak to author Jim Barrett, Senior Data Scientist at UMC, to learn more about the duplicate detection algorithm and UMC’s work to develop AI resources for pharmacovigilance.2024-08-2625 min
Health WealthHow does pharmacovigilance work in India? | Health Wealth, Ep 55Are you googling ‘side effects’ of your medicine even before you’ve left the doctor’s office? But did you know that every chemical (laboratory-made or naturally occurring) taken into our bodies can have a series of effects? We hope some of these effects will cure diseases or disorders of the body and mind. So when you pop a Paracetamol into your mouth, you know it will reduce your fever. It might also give you acid reflux (a common secondary effect of the chemical), and to prevent that, you might also take an antacid. But it is worth the risk...2024-08-1239 min
Cleveland Clinic Cancer AdvancesOncology Pharmacovigilance ClinicThe Cancer Advances podcast is joined by Wen Wee Ma, MBBS, Director of the Novel Cancer Therapeutics Center, and Lucy Boyce Kennedy, MD, Director of the Oncology Pharmacovigilance Clinic. Listen as they discuss how this new Oncology Pharmacovigilance Clinic enhances patient care by addressing complex toxicities and side effects from immunotherapy treatment, and integrates specialists from rheumatology, endocrinology, pulmonology and more.2024-06-2719 minDrug Safety MattersUppsala Reports Long Reads – Ensuring trust in AI/ML when used in pharmacovigilanceEnsuring trust in AI is vital to fully reap the benefits of the technology in pharmacovigilance. Yet, how do we do so while grappling with its ever-growing complexity?This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.After the read, we speak to one of the authors of the article, Michael Glaser, to learn more about how AI and ML has been used in pharmacovigilance so far, and what needs to happen to e...2024-06-2730 min
Innovation and the Future of PharmacovigilanceNicole BakerSend us a textEmbark on a captivating journey with Nicole Baker, the pioneering CEO of Biologit, as she shares her remarkable transition from academia to the forefront of pharmacovigilance on Truliant Talks. Nicole's narrative is not just about her personal evolution but also serves as an illuminating guide through the labyrinth of safety regulations and drug monitoring. Her candid conversation is a deep dive into the importance of patient safety, the impact of regulatory shifts, and the ever-present need for industry adaptability. We examine the significance of professional networks and the influence of major events like...2024-04-0850 min
Xtalks Life Science PodcastPeople in Life Sciences Series: Day-in-the-Life of a Pharmacovigilance Professional – Interview with Ashish Jain, Senior Director of Clinical Safety a...In this featured episode of Xtalks People in Life Sciences, Ayesha spoke with Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance (PV) at Curis, a pioneering biotech company specializing in cutting-edge cancer therapies.
Jain shared his journey into clinical safety and PV, highlighting key milestones along the way. Delving into his daily routine at Curis, he revealed his strategies for prioritizing tasks and staying informed of the latest developments in PV.
Throughout the interview, Jain offered invaluable insights into career advancement in clinical safety and PV. He emphasized the indispensable skills and competencies vital...2024-03-2034 min
SynceIt With MurunwaDikeledi’s career Journey from Medical Affairs graduate, Pharmacovigilance &Medical writerIn this episode am joined by Dikeledi Matlebjane, who hold Science degree from the University of Pretoria. She shares her journey as a Medical Affairs graduate, Pharmacovigilance Officer and Medical writer . I hope her journey ignites hope in you & inspires you!2024-02-291h 09Drug Safety Matters#28 Catching black swans – François MontastrucSerious and unexpected adverse drug reactions – the ‘black swans’ of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the unpredictable.Tune in to find out:What Nassim Nicholas Taleb’s ‘black swan’ theory has to do with pharmacovigilanceWhat makes an adverse drug reaction a black, white, or grey swan Why flexibility and communication are key to patient safetyWant to know more?Here are the research articles cited i...2024-02-2927 minInnovation and the Future of PharmacovigilanceColleen WalshSend us a textDiscover the intricate world of pharmacovigilance as Colleen Walsh, the Vice President of Global Patient Safety Operations at Alnylam, unveils her personal journey through the ever-evolving landscape of patient safety. In this enthralling episode of Innovation and the Future of Pharmacovigilance, I sit down with Colleen to unravel the complexities she's encountered, from the pivotal Tysabri incident at BioGen to leading R&D compliance at Alexion. Her story is a testament to the resilience required in the face of regulatory upheavals and the innovative spirit needed to navigate from clinical trials to post-market...2024-02-2649 minInnovation and the Future of PharmacovigilanceMichael Braun-BoghosSend us a textEmbark on a journey through the dynamic world of pharmacovigilance with Michael Braun-Boghos, the seasoned Senior Director of Safety Strategy at Oracle. In our first episode of the season, Michael unpacks his three-decade odyssey from the analog days of adverse event forms to the digital frontier of pharmacovigilance. As we traverse his career landscape, the evolution from paper trails to strategic IT roles unfolds, highlighting pivotal shifts and the integrative prowess of systems like Argus. Michael's anecdotes from the merge that birthed Astellas to the strategic tides at Relsys before its acquisition by O...2024-01-2953 min
Research in ActionAutomation, innovation, and the future of drug safetyInternational Data Corporation reports safety caseloads are increasing by 30% to 50% each year, and emerging technology will be the only way to keep up. But how are powerful technologies like generative AI advancing safety and pharmacovigilance? Is touchless case processing a good or bad thing? And how do we balance AI, automation, and the human touch? We will get answers to those questions and more in this episode with Bruce Palsulich, Vice President of Safety Solutions at Oracle Life Sciences. His portfolio includes Argus Safety, the industry-leading adverse event case processing and analytics solution, and Empirica Signal, the standard for...2024-01-0935 min
Pharmaceutical ExecutiveReshaping Pharmacovigilance in the age of AISameer Lal, Sr. Vice President, Enterprise Medical Solutions at Indegene, discusses findings from their new study about Reshaping Pharmacovigilance in the age of AI, digital/generative AI opportunities, how quickly the industry is adopting this technology, and much more.2024-01-0417 minInnovation and the Future of PharmacovigilanceCo-Founders End of Year Extravaganza!Send us a textPrepare to have your perceptions of pharmacovigilance revolutionized as we're joined by the trailblazing co-founders of Truliant Consulting. We're peeling back the layers of AI's profound impact on the pharmaceutical industry, revealing how 2023's tech leaps are changing the game for drug safety. From the fascinating convergence of wearables and social media data to the necessity of keeping a laser focus on patient safety, this episode is a treasure trove of insights into the tools and success stories shaping the future of medicine. Navigating the complexities of global regulatory landscapes, we d...2023-12-2541 minDrug Safety Matters#26 What's trending in pharmacovigilance? – Angela CaroWhat did the drug safety community achieve in 2023 and how will the field develop in 2024? As the year comes to a close, we asked Angela Caro, president of the International Society of Pharmacovigilance (ISoP), to walk us through current and future trends in pharmacovigilance.Tune in to find out:Why patient engagement is a growing priorityWhat challenges exist in the Latin American regionWhich topics will be in the spotlight next yearWant to know more?ISoP is a non-profit society open to anyone with an interest in pharmacovigilance.2023-12-2028 min
The Emerging Biotech LeaderWhen's the Best Time to Think About Safety? It's Now - Gregory Fiore : 25“The reality is that the earlier one thinks about and invests in a safety process and a safety system, the more dividends that early thinking pays downstream.” Dr. Greg FioreHarvard-Trained Physician. McKinsey Consultant. Startup Advisor. These are just a few of the titles that describe our next guest, Dr. Greg Fiore. As one might imagine, with these titles comes a unique lens and broad array of experience within the world of pharmacovigilance (PV). Expanding upon the topic of PV and safety from Episode 24, “Cultivati...2023-11-2927 min
Transformation in TrialsHarnessing the Power of Open-Source in Pharmacovigilance with Lionel Van HolleSend us a textReady to lift the lid on the untapped potential of open-source technology in clinical trials? Strap in for a fascinating journey with our guest Lionel van Holle, the founder of Open Source PV. We'll unveil the transformative power of open-source tech in the life sciences industry, including its innate transparency, parallel development capabilities, and cost-effectiveness. Lionel shares insights into the diversity of SAS, R, and Python programmers involved in this field, revealing how the open-source revolution is just around the corner.The collaboration between code and pharmacovigilance is changing the game...2023-11-0141 minInnovation and the Future of PharmacovigilanceFraser McCullumSend us a textFeeling intimidated by the thought of AI transforming the world of pharmacovigilance? Join us as we sit down with Fraser McCullum, founder of Imagine Pharmacovigilance Limited, who has spent over 20 years navigating the dynamic landscape of this industry. From his time as a bench scientist to establishing his own company, Fraser offers an insightful perspective on case processing to signal detection, and the future of risk management in pharmacovigilance. Our conversation also delves into the feared impact of AI on the conservative PV industry. Fraser clears the air on some widespread m...2023-10-3050 minInnovation and the Future of PharmacovigilanceInnovation and the Future of PharmacovigilanceSend us a textWelcome to Truliant Talks, your definitive source for the world of pharmacovigilance amd risk management.As we enter an era defined by innovation and technological advancement, Truliant Talks is proud to announce a new podcast series, 'Innovation and the Future of Pharmacovigilance'.This holistic series will tackle every perspective of pharmacovigilance - from the role of regulators, the importance of vendors, to embracing AI, data privacy, and much more.We'll feature leaders, innovators, and visionaries - the people shaping pharmacovigilance. They'll share their experiences, insights, tips, and...2023-10-2601 minDrug Safety MattersUppsala Reports Long Reads – The colour of signalsHerbal remedies have been used for thousands of years to treat what ails us. Yet why do we still know so little about their potential side effects compared to modern medicines?This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.After the read, we speak to author Daniele Sartori to learn more about the challenges in herbal pharmacovigilance.Tune in to find out:Why the risks of herb...2023-09-2933 min
elinciaherwynnEbook READ ONLINE Cobert's Manual of Drug Safety and Pharmacovigilance 3rd Edition ^DOWNLOAD@PDF#)}**Download Cobert's Manual of Drug Safety and Pharmacovigilance: 3rd Edition Full Edition,Full Version,Full Book**by Barton L. CobertReading Now at : https://happyreadingebook.club/?book=9811215235ORDOWNLOAD EBOOK NOW!Read PDF Ebook READ ONLINE Cobert's Manual of Drug Safety and Pharmacovigilance: 3rd Edition ^*DOWNLOAD@PDF#)} Ebook Online PDF Download and Download PDF Ebook READ ONLINE Cobert's Manual of Drug Safety and Pharmacovigilance: 3rd Edition ^*DOWNLOAD@PDF#)} Ebook Online PDF Download by Barton L. Cobert2023-09-1000 minDrug Safety MattersUppsala Reports Long Reads – Empowering patients as partnersA patient's perspective can ensure safe medical care and lead to new insights that traditional research may overlook. But how do we best harness that perspective to improve patient outcomes?This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.After the read, we speak to Manal Younus, who authored the article, to learn more about patient engagement and its benefits for medicines safety.Tune in to find out:Ho...2023-09-0542 min
Medtalks DailyNow its Reality! Wearable device in Pharmacovigilance systemIn today's episode of 14th August 2023, we will talk about use of wearable device in the field of Pharmacovigilance2023-08-1403 min
Medtalks DailyChatGPT is disrupting the Pharmacovigilance ?In today's episode of 28th July 2023, we will talk about applications of ChatGPT in the field of Pharmacovigilance and will it impact the Pharmacovigilance professionals ?2023-07-2805 min
Cracking the code - pharmaceutical industry careersEpisode 12: Nav Lee, pharmacovigilance expert and big supporter of new talentsNav has worked in the pharmacovigilance world for a considerable amount of time now. She also created an internship program out of her own time for university students to explore pharmacovigilance. Of the 4 she recruited, ALL of them were able to find jobs afterwards in the pharmaceutical industry!Tune in to hear more. 2023-07-1717 min
PharmaLex TalksSafety Reporting Requirements for Marketing in the EUFor US-based companies seeking to market their product in the EU, it can be a struggle to navigate a different market, and, in particular, to manage requirements from a safety reporting perspective. The podcast explores the challenges faced managing not only the European pharmacovigilance legislation but also dealing with each EU Member State, which can implement these requirements in their own way at the national level.
Bios:
Monica Buchberger is senior director of pharmacovigilance at PharmaLex, drawing on her many years in industry in pharmacovigilance and regulatory roles, including quality assurance systems and serving as the...2023-07-0620 minDrug Safety Matters#22 Reforming pharmacovigilance education – Michael ReumermanHealthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers.Tune in to find out:How real-life education can benefit healthcare studentsWhich educational intervention can be most impactfulHow adverse drug event managers can improve pharmacovigilanceWant to know more?In his PhD thesis, Michael details the current state of pharmacovigilance education and all the real-life interventions he...2023-05-0832 min
Caris Molecular Minute Podcast SeriesInterview with Dr. R. Donald Harvey: Pharmacovigilance and PharmacoadherenceCaris Precision Oncology Alliance™ Chairman, Dr. Chadi Nabhan, sits down with Dr. R. Donald Harvey, Professor, Department of Hematology and Medical Oncology at Emory University School of Medicine and Director of Winship Cancer Institute's Phase I Clinical Trials Unit. Together they discuss the role of the pharmacist in pharmacovigilance and pharmacoadherence, and how we can ensure that patients are being properly educated and compliant with the new products being approved each day.
For more information, please visit: www.CarisLifeSciences.com2023-04-2623 min
Caris Molecular Minute PodcastsInterview with Dr. R. Donald Harvey: Pharmacovigilance and Pharmacoadherence
Caris Precision Oncology Alliance™ Chairman, Dr. Chadi Nabhan, sits down with Dr. R. Donald Harvey, Professor Department of Hematology and Medical Oncology at Emory University School of Medicine and Director of Winship Cancer Institute's Phase I Clinical Trials Unit. Together they discuss the role of the pharmacist in pharmacovigilance and pharmacoadherence, and how we can ensure that patients are being properly educated and compliant with the new products being approved each day.
For more information, please visit: www.CarisLifeSciences.com
2023-04-2623 min
AI For Pharma GrowthE57 | How to use AI for Drug Safety and PharmacovigilanceIn this episode of AI For Pharma Growth, Dr Andree Bates is joined by Raj Vaghela, CEO of PubHive, a company leveraging AI to automate drug safety and pharmacovigilance processes. Pharmacovigilance professionals now face a significantly increased workload to evaluate this high volume of data. AI-powered technologies can help alleviate this burden, while ensuring a more precise and systematic evaluation of available data. Raj discusses the use of AI in improving drug safety and pharmacovigilance across different areas such as literature monitoring, safety reviews, aggregate reporting, signal surveillance, and detection. In th...2023-04-1918 minDrug Safety Matters#21 Unlocking the power of real-world data – Patrick RyanThe vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson & Johnson discusses how to harness real-world data for patient safety.Tune in to find out:How real-world data is collected and analysedWhich pharmacovigilance processes will benefit most from itHow to make data accessible without infringing patient privacy Want to know more?Review the basics of real-world data and its use...2023-03-3033 min
EMJ GOLD: Pharma marketing, medical & morePav Rishiraj on pharmacovigilanceThis GOLD Nugget episode sees Helena reflect on some of the best insights offered by Pav Rishiraj, Director and Head of Pharmacovigilance at Ipsen. She shares some of Pav's thoughts on how the often under-recognised field of pharmacovigilance has changed – particularly its rapid evolution during the COVID-19 pandemic – and its importance as a strategic enabler, as well as Pav's advice on what pharma should do to ensure teams feel valued and integral to the businesses they serve. If you’re interested in learning more about the topic areas discussed in this episode, check out the following content: ...2023-01-1711 minDrug Safety Matters#19 Lessons in pandemic pharmacovigilance – Elena RoccaThe COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety.Tune in to find out:How to handle uncertain evidenceWhy clinical expertise matters in the age of big dataWhy pharmacovigilance requires interdisciplinary thinking Want to know more?In the article that inspired this episode, Elena Rocca and Birgitta Grundmark describe the pra...2022-12-1533 min
Astrix Digital Transformation PodcastEpisode #12 The impact of Artificial Intelligence (AI) and Machine Learning (ML) in PharmacovigilanceEpisode #12 November 2022In this Episode, we focus on the impact of Artificial Intelligence (AI) and Machine Learning (ML) in Pharmacovigilance. We discuss some of the key terminology associated with AI, some of the drivers of AI and ML in PV, as well as how these technologies are answering the call of duty today and how they will continue to impact the PV area into the future.2022-11-0729 min
EMJ GOLD: Pharma marketing, medical & moreS03E2: Pharmacovigilance past, present and futureThis week, Marc and Helena are joined in the podcast studio by Pav Rishiraj, Director and Head of Pharmacovigilance at Ipsen, to shed some light on this often-overlooked field of pharma. He discusses his career journey in pharmacovigilance and how, in his experience, the field has changed; the importance of pharmacovigilance as a strategic enabler within businesses; and the outlook for the future of the field in terms of AI and automation. Helena also leads a short tribute to Her Majesty Queen Elizabeth II. If you’re interested in learning more about the topic areas discussed in this...2022-09-1335 min