Podcasts about Pharmacovigilance

Send us a voicemail!Global pharmacovigilance requires harmonised methods, but solutions must be tailored to the local context. We sat down with Salvador Alvarado and Matthew Barwick from Uppsala Monitoring Centre to explore how local constraints affect drug safety and how a new film series by UMC can inspire PV professionals across borders.Tune in to find out:How the thalidomide tragedy triggered a global pharmacovigilance collaborationHow UMC supports members of the WHO Programme for International Drug MonitoringHow to communicate science effectively on cameraWant to know more?Watch The WHO PIDM in Focus film series on YouTube.Read about the benefits of the WHO PIDM, its members and UMC's role in the programme.Revisit these related episodes from the Drug Safety Matters archive:Unpacking the WHO Global Smart Pharmacovigilance StrategyCommunicating science through filmGot a story to share?We're always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Black box warnings, underreported events, and biased guidelines—Cassels exposes the fragile truth behind drug “safety.” #BlackBoxWarnings #DrugRisks #HealthTransparency #HealthTalks

From suppressed trials to post-drug syndromes, learn how real drug harms are hidden—and who pays the price. #DrugHarms #HiddenData #Paxil #HealthTalks

What happens behind the scenes to ensure new therapies are safe for patients? In this episode of Moving Medicine Forward, we are joined by John Kane, Vice President of Pharmacovigilance and Safety Services at CTI, to explore the critical role of drug safety throughout the clinical development process. John shares how safety teams collect and evaluate adverse event data, navigate complex global regulations, and help protect patients from clinical trials through post-market surveillance. He also discusses the growing impact of AI in pharmacovigilance, the continued growth of North Carolina's Research Triangle, and the rewarding career opportunities available in clinical research. 01:13 – Finding a Career in Clinical Research John shares how he transitioned from nursing into the clinical research industry.  02:14 – CTI's Growth in Raleigh Why North Carolina's Research Triangle continues to attract biotech companies and research talent. 04:55 – Understanding Pharmacovigilance What pharmacovigilance is and how safety teams collect, evaluate, and report adverse events throughout a drug's lifecycle. 07:33 – Protecting Patients Through Drug Development How CTI safety teams monitor risks, identify safety signals, and communicate important findings to regulators and investigators. 09:55 – Navigating Global Regulations The growing complexity of global safety reporting requirements and regulatory compliance. 11:51 – The Role of AI in Drug Safety How AI may improve data processing, signal detection, and scientific literature review. 13:53 – A COVID-19 Success Story John reflects on supporting a large COVID-19 trial and managing high volumes of safety data. 14:38 – Collaboration at CTI Why teamwork and collaboration are key to successful clinical trials and patient impact.  15:32 – Advice for Future Research Professionals Career opportunities in clinical research and how CTI helps new professionals enter the field.

Send a text message to the show!Pharmacovigilance has traditionally focused on the patient at the receiving end of a medicine. But what happens to medicines once they leave the body? In this episode, Valentina Giunchi and Joe Mitchell unpack the emerging field of ecopharmacovigilance and explore how the One Health approach is reshaping the way we think about medicine safety across human, animal, and environmental systems. Tune in to find out:Where in the environment pharmaceutical residues are turning up, and why this should be on every pharmacovigilance scientist's radarHow the dramatic collapse of India's vulture populations in the early 2000s speaks to the importance of the One Health approach Practical solutions, from smarter prescribing and greener pharmaceuticals to take-back schemes for unused medicines, that can help curb pharmaceutical pollution.Want to know more?For a deep dive into ecopharmacovigilance, the following references provide foundational information on the topic in pharmacovigilance, most of them penned by Professor Giampaolo Velo, who coined the term:The revised Erice declaration for the inclusion of environmental issues in pharmacovigilanceA book chapter on ecopharmacovigilance in the 2017 SpringerLink book “Pharmacovigilance”, featuring our very own Ralph Edwards and Marie Lindquist as editorsA paper summarising the main concepts in ecopharmacovigilance and pharmaceutical pollutionA paper with Valentina Giunchi as a co-author on environmental sustainability as an essential component of rational medicine use.A recent paper with Joe Mitchell as a co-author, using the One Health approach to investigate pharmacovigilance database reports on antimicrobial resistance. Got a story to share?We're always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send a text message to the show!For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn't abuse this powerful but fragile tool.Tune in to find out:Why we should never treat disproportionality signals as verdictsHow poorly performed analyses affect scientists, regulators and patientsHow to avoid the most common sources of bias Want to know more?Michele and Eugene's paper in Drug Safety is a concrete guide to charting and sidestepping the pitfalls of disproportionality analysis.In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help map and address biases in disproportionality analysis.Michele also reviewed the method's limitations in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality'.Last year, Retraction Watch covered the spike in pharmacovigilance studies in the literature and why some journals decided to ban drug safety database papers.Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV guidelines for reporting disproportionality analyses.In 2016, the IMI PROTECT project published recommendations to improve signal detection practices, especially for quantitative methods like disproportionality analysis.UMC's guidebook on signal detection in small datasets offers step-by-step advice for qualitative methods and manual case review.Got a story to share?We're always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send us a textBeyond Medicines: How Pharmacovigilance Professionals Save Lives Without Wearing a White CoatWhat if saving lives didn't require a stethoscope, a hospital ward, or a white coat?In this deeply insightful episode of The Kapeel Gupta Career PodShow, we explore one of the most underrated yet powerful careers in global healthcare — Pharmacovigilance.Behind every medicine you trust is a silent professional analysing safety reports, identifying patterns, and protecting patients across the world. This episode reveals how Pharmacovigilance Professionals quietly safeguard millions of lives without ever meeting a patient face to face.If you are: ✔ A science student who loves healthcare but not hospital routines ✔ Confused between pharmacy, research, and corporate roles ✔ Looking for a stable, global, future-proof career ✔ Interested in drug safety, ethics, and real-world impact— this episode is for you.In this episode, you'll learn:

In this episode of the Functionally Speaking series, host Lynn Hamilton speaks with Carol Aliyar, Executive Vice President and Global Head of Safety and Pharmacovigilance (PV) at Syneos Health, about the transformation of PV from a highly regulated, task-oriented function into a more strategic and technology-enabled discipline. With over 30 years in the industry and a career that spans commercial, clinical and safety roles, Carol brings a rare full-spectrum perspective. Listeners will gain insight into:How PV is shifting from transactional taskwork to strategic lifecycle integrationWhat AI and automation really mean for safety operations and talent needsThe enduring importance of human judgment, especially in the age of AI agentsWhy functional service provider (FSP) models are now resonating in PVHow consistency, flexibility and subject matter depth strengthen long-term partnerships Whether you're expanding your PV model, exploring AI adoption or rethinking how functional teams deliver value, this conversation offers real-world perspective and practical foresight.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 https://www.syneoshealth.com/insights-hub. 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.

This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO's newly finalised Global Smart Pharmacovigilance Strategy. In this episode, you'll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.Want to know more?Read WHO's “Global smart pharmacovigilance strategy” (Geneva: World Health Organization; 2025). Explore WHO's work on pharmacovigilance through the Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team.Learn more about regulatory systems strengthening and the WHO Global Benchmarking Tool (GBT) for medicines and vaccines.Discover the WHO network for regulatory systems strengthening – the Coalition of Interested Parties (CIP), of which UMC is a member.Visit the UMC website to find out more about the WHO PIDM and UMC's role in it. Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn't – go next.Tune in to find out:How to keep up with rapid developments in AI technologyWhy model and performance transparency both matterHow to protect sensitive patient data when using AIWant to know more?Listen to the first part of the interview here.In May 2025, the CIOMS Working Group XIV drafted guidelines for the use of AI in pharmacovigilance. The draft report received more than a thousand comments during public consultation and is now being finalised.Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article.Other recent UMC publications cited in the interview or relevant to the topic include:a pre-print on the revised vigiMatch algorithm for duplicate detectionan article on the pitfalls of disproportionality analysisa pre-print on critically appraising AI applications for rare-event recognitionFor more on the ‘black box' issue and maintaining trust in AI, revisit this interview with GSK's Michael Glaser from the Drug Safety Matters archive. Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn't – go next.Tune in to find out:Why pharmacovigilance needs specific AI guidelinesHow a risk-based approach to AI regulation worksWhere in the PV cycle is human oversight most neededWant to know more?In May 2025, the CIOMS Working Group XIV drafted guidelines for the use of AI in pharmacovigilance. The draft report received more than a thousand comments during public consultation and is now being finalised.Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article. His favourite definition of AI remains the one proposed by Jeffrey Aronson in Drug Safety.For more on maintaining trust in AI, revisit this interview with GSK's Michael Glaser from the Drug Safety Matters archive.The AI methods developed by UMC and cited in the interview include: vigiMatch for duplicate detectionvigiGroup for clusteringvigiRank for signal detectionvigiGrade for case report completeness scoringWHODrug Koda for automated coding Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

In this episode, BioSpace's head of insights Lori Ellis discusses the FDA's first draft guidance for AI in drug development, published in January 2025, with Archana Hegde, Senior Director, PV systems and innovations at IQVIA.

Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.Tune in to find out:Why we need a Patient Safety DayHow to prevent common medication errors in childrenHow to build child-friendly healthcare environmentsWant to know more?Visit the World Health Organization's campaign website to learn more about World Patient Safety Day and download campaign materials.You can also show support for the campaign by joining ISoP's free virtual event on September 18 and 19, or visit ISoP's YouTube channel to access recordings from previous Patient Safety Day events.For more on paediatric pharmacovigilance and ISoP's activities, check out these episodes from the Drug Safety Matters archive:The KIDs ListWhat's trending in pharmacovigilance? Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

While AI excels at repetitive tasks like triaging medical information calls, document retrieval, and adverse event detection, the industry must address valid concerns from physicians (41% are excited but concerned, according to AMA studies) and patients who distrust AI systems. In this episode, IQVIA's Louise Molloy advocates for complete transparency, including clear disclaimers when AI generates or supports responses, arguing that the industry serves as "custodians, not owners" of patient data with ethical responsibilities.This episode is presented in partnership with ⁠IQVIA⁠.Host⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestLouise Molloy, Associate Director Medical Information & Pharmacovigilance, IQVIADisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

In 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 & Innovations, IQVIADisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

This 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 engagement in pharmacovigilance.The symposium was a collaboration between ISoP and UMC. Want to know more?Visit the official website of the 2025 ISoP Mid-Year Symposium to learn more about its sessions, speakers and chairs. Not patient but im-patient – read about Sara Riggare's research on patient engagement and other topics.Listen to Henry Zakumumpa talk about his study on adverse event reporting quality in Uganda in this 2025 episode of Drug Safety Matters.Read about the PhD project of Tommy Emil Dzus, Improving causality assessment in pharmacovigilance for safe and sustainable use of medicines in health emergencies, at Oslo Metropolitan University, Norway.Sabine Koch is Head of the Department of Learning, Informatics, Management and Ethics (LIME), at Karolinska Institutet, Stockholm.Details on Mikael Hoffman's research can be found on his profile page on ResearchGate.Take a look at what's in store for participants at the 24th Annual Meeting of ISoP in Cairo, on October 24–27, 2025.Visit the websites of the Drug Safety Research Unit (DSRU), ISoP, Centre Anti Poison et Pharmacovigilance du Maroc, and Uppsala Monitoring Centre, to find out more about their work. Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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.

Pharmacovigilance 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 for Elyse to read out on the pod. It's fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

In 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.

There 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 scientist Lovisa Sandberg from this team, discuss complexities and challenges of pregnancy-related PV, and new solutions for addressing those challenges. Tune in to find outWhy is the world still behind when it comes to pregnancy-related pharmacovigilance?What are the challenges faced by pharmacovigilance assessors wanting to look at pregnancy cases?How can healthcare professionals, patients and carers help assessors overcome these challenges, when reporting pregnancy-related adverse drug events?How can the VigiBase pregnancy algorithm, and other algorithms, support the identification of pregnancy cases?How to use the VigiBase pregnancy algorithmUsers of VigiLyze and VigiBase Custom Searches can use the VigiBase pregnancy algorithm as a filter when performing searches. In the qualitative view in VigiLyze, click on “Filter” -> “Patient” -> “Pregnancy” to apply the filter.Want to know more?Read about the VigiBase pregnancy algorithm in this Uppsala Reports article and in this poster, presented at the International Society for Pharmaceutical Engineering (ISPE) 2024 annual meeting. EURAP – an international prospective observational study of pregnancies with antiepileptic drugs. EURAP - International Registry of Antiepileptic Drugs and PregnancyThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files: ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-filesThe concePTION project: https://www.imi-conception.eu/Medical Dictionary for Regulatory Activities (MedDRA®) support documentation: https://www.meddra.org/how-to-use/support-documentation/englishZaccaria C, Piccolo L, Gordillo-Marañón M, et al. Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance. Drug Saf. https://doi.org/10.100Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

David Liew talks to Claire Larter, a medical officer at the pharmacovigilance branch of the TGA, about her paper on adverse event reporting. Claire explains why pharmacovigilance is important for clinicians, and outlines what type of adverse events should be reported. The conversation also covers the process of reporting adverse events and how the TGA handles reports. Read the full article by Claire and her co-authors in Australian Prescriber.

Human 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. In part 2, you will hear aboutdifferences in types of ADRs reported for animals as compared to humans,when humans are accidentally exposed to medicines for animals, and vice versa,how the many species and breeds included in veterinary PV affects the coding of ADR reports, breed-specific ADRs – what is safe for one breed of e.g. dog or pig, may not be appropriate for another, the EU Veterinary Big Data Strategy,... and much more! Links for further readingThe public portal of the European Union Veterinary Pharmacovigilance Database.One Health – an integrated approach to the well-being of people, animals and the environment.A survey of veterinary professionals in Sweden, about practices and attitudes in relation to ADR reporting.A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicines. The EMA Big Data strategy for veterinary medicines. Data quality framework for medicines regulation | European Medicines Agency (EMA)Small Animal Veterinary Surveillance Network (SAVSNET) - University of LiverpoolVetCompass - Royal Veterinary College, RVCReflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA)Veterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA)Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) | European Medicines Agency (EMA) Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Clinical research is undergoing a revolution in light of new demands for speed and opportunities from a technological standpoint. These trends have given rise to a debate about the quality and clinical meaning of traditional methods of investigations versus modern types of clinical studies to collect real world evidence. This debate at the 3rd annual Medical Affairs Innovation Olympics #MAIO2024 in a unique and exciting format with a live poll at the conclusion, features an animated discussion from three speakers: Rashad Massoud, MD, MPH, CEO of Rashad Massoud Associates, LLC., globally recognized healthcare quality expert, physician, formerly visiting faculty at the T.H. Chan School of Public Health; Suzanne Pavon (moderator), Doctor of Pharmacy, Board Member at Iethico, former Vice President of Pharmacovigilance and Quality at Argenx; and Sana Syed, Senior Medical Director - Clinical Lead at Sanofi and public health expert formerly at T.H. Chang School of Public Health. Debate Objectives: ● To discuss the utility of RCTs in research and learning ● To discuss the challenges in translating RCT findings into the real-world environment ● To review the utility of the RCT approach to facilitate real world implementation ● To review the impact of the RCT approach for impact and limitations ● To discuss alternative research methods for research and learning ● To conclude with the research approaches that fit best for clinical trials and the real world; indicating a need for an adaptive, dual approach. 0:00 Alloutcoach Intro Music 0:09 Episode Highlight 3:09 Innovation Olympics Introduction 4:44 Debate Rules & Introduction 6:30 RCTs are the Gold Standard for Research and Learning - For the Motion - Sana Syed 8:12 The Scientific Method - Standard RCT Design 9:46 Rare Disease Case Study 11:38 Translating Biology vs Translating Real World Factors 14:34 Diversity of patients critical for data to represent populations 18:50 RCTs are NOT the Gold Standard for Research: Against the Motion - Rashad Massoud 20:27 Properties of an RCT 21:19 Other Research Questions to Eliminate Other Factors that may influence the results 24:13 Access Questions and Outcomes of Interest - Discovery and Delivery 24:48 Agency for Healthcare Research and Quality (AHRQ) - ~17 yrs to translate data into real world 26:33 Efficacy vs. Effectiveness Research 31:02 Concluding Remarks - case study in which RCT designs are not beneficial 35:30 Question: Health Avatar and AI to create real and virtual control arm Using virtual control arm using real world databases using Bayesian statistical methods 39:23 Case study to emphasize Harnessing Tacit knowledge 42:02 Comment: Weaknesses in generating data we can translate into populations 43:44 Question: Are we creating RCTs from virtual patients or classical RCT design? 47:34 Final Comments - For the Motion, Sana Syed Clinical Studies and Scientific Method - adjustments in diverse patient recruitment tactics 49:31 Final Comments - Against the Motion, Rashad Massoud 53:14 Live Voting Results

Human 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 veterinary and human pharmacovigilance?How is animal health connected to public health? What types of adverse events are reported on the veterinary side compared with the human side? What can be found in the EU veterinary pharmacovigilance database?  Want to know more?The new veterinary medicines regulation (Regulation (EU) 2019/6) can be found here. The public portal of the European Union Veterinary Pharmacovigilance Database.WHO's information page on One Health, an integrated approach to the well-being of people, animals and the environment.A survey of veterinary professionals in Sweden, about current practices and attitudes in relation to adverse events reporting and the accessibility of product safety information.A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicinal. A study looking at suspected adverse drug reaction reporting in veterinary free‐text clinical narratives.The EMA Big Data strategy for veterinary medicines in the EU. Data quality framework for medicines regulation | European Medicines Agency (EMA)Small Animal Veterinary Surveillance Network (SAVSNET) - University of LiverpoolVetCompass - Royal Veterinary College, RVCReflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA)The Swedish Medical Products Agency's online reporting form for suspected adverse drug reactions in animals (In Swedish).  Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

In this heartfelt episode of The Patient From Hell, host Samira Daswani talks to Jill Massey, a pharmacist and pharma industry veteran whose path through cancer has been both personal and professional. Jill shares her experiences as a caregiver for her sister, mother, and husband—all cancer patients—before becoming a patient herself. They discuss the emotional and practical challenges of navigating caregiving, the complexities of the healthcare system, and how Jill's unique perspective as both a medical professional and a patient shaped her approach to advocacy, treatment decisions, and resilience. Key Highlights: 1. A Personal and Professional Journey: Jill reflects on how her family's battles with cancer shaped her career in the pharmaceutical industry, blending personal empathy with professional expertise. 2. Balancing Roles and Emotions: From sibling to spouse to patient, Jill shares the unique emotional dynamics of each role and the coping mechanisms she developed. 3. Empowerment Through Knowledge: Jill emphasizes the importance of patient education, advocating for personalized care, and the evolving role of pharmaceutical companies in supporting patient-centric care. About our guest: Jill Massey, PharmD, MBA, BCMAS is Vice President, Global Medical Strategy and Operations (GMSO) for Gilead Medical Affairs.  In this role, Jill oversees the Patient-focused Implementation Science team, Medical Strategy and Planning, Insights, Data & Analytics and Digital Innovation, Medical Excellence, Medical Affairs Technology, and Scientific Communications including global publications, medical information, medical external affairs and education, and library and information services.   Jill joined Gilead Sciences from Immunomedics where she led the Medical Affairs, Safety and Pharmacovigilance organizations.  Prior to that, she led Medical Affairs at Janssen, The Medicines Company and Melinta Therapeutics as well as the Melinta Global Antimicrobial Resistance Program. She began her career in the pharmaceutical industry at Bristol-Myers Squibb Company.  Previous to her industry roles, Jill was clinical faculty at the Saint Louis College of Pharmacy, Jewish Hospital and the Program on Aging at Washington University School of Medicine.  Jill is a member of the Board of Directors for the Morris County Chamber of Commerce and serves on the Life Sciences Council Steering Committee.  She is a member of the National Advisory Committee for the Robert A. Winn Diversity in Clinical Trials Award Program, a member of the Accreditation Council of Medical Affairs Executive Leadership Board and a member of the Seton Hall University Transformative Leadership Advisory Board.   Jill earned her Doctor of Pharmacy degree from the University of Nebraska Medical Center and her MBA from Drexel University LeBow College of Business. She completed a residency at Mercer University School of Pharmacy and Emory University. She is Board Certified by ACMA.   Jill loves running, baking and spending time with her two kids, Maddie and Alex, and her loved ones, sometimes including her two dogs and cat. Disclaimer: All content and information provided in connection with Manta Cares is solely intended for informational and educational purposes only.  This content and information is not intended to be a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient's full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other questions were addressed in an exploratory interview study by UMC researchers Joana Félix and Alem Zekarias.  Tune in to find out:What challenges are PV assessors faced with, when working with narratives? How could automation of certain tasks help streamline narrative analyses in the future?How can reporters craft narratives that effectively document adverse events? Want to know more?Pharmacovigilance assessors' experiences interacting with narrative fields in spontaneous reports: an exploratory interview study – poster presented at the 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”, 1–5 October 2024 Montreal, Canada.Current Challenges in Pharmacovigilance: Pragmatic Approaches, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices. Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Medication-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 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 frailty is far more useful than age in predicting adverse drug reaction riskHow pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials.Want to know more?This interview all started with Giovanni's Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it here.For a summary of the key points discussed in this interview, read Giovanni's paper on the status of drug safety in geriatric patients.If our discussion of frailty piqued your interest, read this paper on the biology of frailty and how this impacts clinical pharmacology, this multi-centre cohort study that shows frailty is significantly correlated with MRH, and this commentary advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such. As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his paper.For more on prescribing cascades, their prevention, detection, and reversal, read this paper by Brath and colleagues.Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Imagine knowing how your body will respond to a medication before you even take it! In this episode, Harsh Thakkar interviews Sarah Rogers, co-founder and president of the American Society of Pharmacovigilance (ASP) and an Assistant Professor at Texas A&M. Together, they dive deep into the fascinating world of pharmacogenomics—how your genetic makeup affects your response to medications. They discuss the challenges of pharmacogenomic testing, real-world examples of adverse drug reactions, and the future of personalized medicine. Chapters:00:00 - Intro00:16 - Breaking Down Pharmacogenomics01:39 - Guest Introduction: Sarah Rogers  02:18 - Explaining Pharmacogenomics to a Child03:24 - Sarah's Start in Pharmacogenomics  04:54 - The Power of Pharmacogenomics07:00 - Pharmacogenomics Clinic at Texas A&M  09:02 - Challenges of Standardizing PGX Testing11:14 - The Ideal Pharmacogenomics Workflow13:39 - Real-World Example of PGX in Action15:44 - Importance of Integrating PGX into EHR 20:24 - AI and Digital Twins in Pharmacogenomics21:52 - Lessons Learned in Pharmacogenomics24:46 - Looking to the Future of Personalized Medicine28:18 - Final Takeaway  30:22 - Outro Connect with Sarah Rogers:- LinkedIn: (https://www.linkedin.com/company/american-society-of-pharmacovigilance)  - STRIPE Initiative LinkedIn: (https://www.linkedin.com/company/stripe-pharmacogenomics)  - Twitter: (https://twitter.com/amsocietypharm)  - Newsletter signup for the American Society of Pharmacovigilance:  https://www.stopadr.org/Here are links for some of the information that I mentioned during our meeting:- STRIPE Annual Meeting and Consensus Workshop - (https://www.usp.org/node/289416) - Collaborative Communities: Addressing Health Care Challenges Together(https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together)- Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community - (https://stopadr.org/stripe)- Texas A&M Interprofessional Pharmacogenomics (IPGx) Clinic - (https://ibt.tamu.edu/cores/Texas%20ClinicoGenomics/Texas%20ClinicoGenomics.html)- National Action Plan for Adverse Drug Event Prevention - (https://health.gov/sites/default/files/2019-09/ADE-Action-Plan-508c.pdf)- Figure showing Stakeholders Involved in the Lifecycle of a Pharmacogenomics Test(https://www.nature.com/articles/s41397-024-00345-y/figures/1)- Subscribe to our podcast for more insights on life sciences: 

Disproportionality 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? Read the READUS-PV guidelines, why they were created, and why they are important. In 2021, Khouri and colleagues showed that current methods and models used for disproportionality analyses are unreliable, and Mouffak and colleagues found that there is a tendency to overstate results in published disproportionality analyses. A book on data mining techniques in Pharmacovigilance by Poluzzi and colleagues delves deeper into this exponential increase in disproportionality analyses.  This paper elaborates on the Delphi technique, and how it is used to gather data from reviewers to achieve scientific consensus on a problem. Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

What is the MOSAIC-NLP project around structured and unstructured EHR data? Why is structured data not really enough for drug safety studies? And to what degree is NLP speeding up access to data and research results? We will learn all that and more in this episode of Research in Action with Dr. Darren Toh, Professor at Harvard Medical School and Principal Investigator at Sentinel Operations Center. www.oracle.com/health www.oracle.com/life  www.sentinelinitiative.org -------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;26;14 What is the MOSAIC and LP project around structured and unstructured data? Why is structured data not really enough for drug safety studies? And to what degree is NLP speeding up access to data and research results? We'll find all that out and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;26;14 - 00;00;50;14 I'm Mike Stiles. And today our guest is Dr. Darren Toh, professor at Harvard Medical School and principal investigator at Sentinel Operations Center. He's got a lot of expertise in Pharmacoepidemiology as well as comparative effectiveness research and real-world data. So, Darren, really glad to have you with us today. Thank you. My pleasure to be here. Well, tell us how you wound up where you are today.   00;00;50;14 - 00;01;26;22 What what attracted you in the beginning to public health? Good question. So I trained in pharmacy originally, and I got my Masters degree in Pharmaceutical Outcomes Research at a University of Chicago, Illinois, Chicago. And it's where I first learned about a field called Pharmacoepidemiology, which sort of very interesting to me because I like to solve problems with methods and data and pharmacoepidemiology.   00;01;26;22 - 00;02;00;29 It seems to be able to teach me how to do that. So I got into the program at the Harvard School of Public Health, and when I was finishing up, I was deciding between staying in academia and going somewhere and getting a real job. And that's when I found out about an opportunity within my current organization and I've heard great things about this organization.   00;02;00;29 - 00;02;29;26 So I thought I would give it a try. And the timing turned out to be perfect because when I joined, our group was responding to a request for proposal for what is called a mini sentinel pilot, which ultimately became the sentinel system that we have today. So I've been involved in the Sentinel system since the very beginning or before we began.   00;02;29;28 - 00;03;02;25 And for the past 15 years I've been with the system and the program and because I really like its public health mission and I'm also very drawn to the dedication of FDA, our partners and my colleagues to make this a successful program. Well, so now here you are, a principal investigator. What exactly is the Sentinel Operations Center? What's what's the mission there and what part do you specifically play in it?   00;03;02;27 - 00;03;52;26 Sentinel is a pretty unique system because it is a congressionally mandated system. So the Congress passed what is called the FDA Amendments Act in 2007. And within that FDA, the Congress asked FDA to create a new program to complement FDA existing systems to monitor medical product safety and more specifically, the Congress, US FDA, to create a post-market risk identification and analysis system that will be using data from multiple sources that will cover at least 1 million lives to to look at the safety of medical products after they are approved and marketed.   00;03;52;28 - 00;04;33;07 So in response to this congressional mandate, FDA launched what is called a Sentinel initiative in 2008 and in 2009 as I mentioned, FDA issued its request for proposal to launch the Mini Sentinel Pilot program, and the program grew into the sentinel system that we have today. So it's for my involvement. It sort of grew over time. So when I joined, as I mentioned, we were responding to this request for a proposal and we were very lucky to be awarded the contract.   00;04;33;09 - 00;05;04;05 So when it was starting, I serve as a one of the many epidemiologists on the team and I led several studies and I gradually took on more leadership responsibility and became the principal investigator of the Sentinel Operations Center in 2022. So I've been very fortunate to have a team of very professional and very dedicated colleagues within the operations center.   00;05;04;05 - 00;05;27;26 So on a day to day basis, we work with FDA to make sure that we can help them answer the questions they would like to get addressed. And we also work with our partners to make sure that they have the resources that they need to answer the questions for FDA. And most of the time I'm just the cheerleader in chief just to share my colleagues and our collaborators.   00;05;27;28 - 00;06;11;23 Now that's great. And and then specifically, there's the Mosaic NLP project that you're involved with. What is that trying to achieve and what are the collaborations being leveraged to get that done? So Sentinel Systems has always had access to medical claims data and electronic health record data or year data. One of the main goals for the current sentinel system is to incorporate even more data, both structured and unstructured, into the sentinel system and to combine it with advanced analytic methods so that FDA can answer even more regulatory questions.   00;06;11;25 - 00;06;40;09 So the Mosaic and NLP project was one of the projects that FDA funded to accomplish this goal. So the main goal of this project is to demonstrate how billing claims and data from multiple sources when combined with advanced machine learning and natural language processing methods, could be used to extract useful information from unstructured clinical data to perform a more robust drug safety assessment.   00;06;40;11 - 00;07;21;18 When we tried to launch this project, we decided that we would issue our own request for proposal. So there was an open and competitive process, and Oracle, together with their collaborators, were selected to lead this project. So I want to talk in broad or general terms right now about data sharing, the standards and practices around that. It kind of feels silly for anyone to say it's not needed, that we can get a comprehensive view and analysis of diseases and how they're impacting the population without it.   00;07;21;20 - 00;07;46;15 NIH is on board. It updated the DMS policy to promote data sharing. You know, the FDA obviously is leaning into this. So is data sharing now happening and advancing research as expected, or are there still hang ups? So I think we are making good progress. So I think the good news is data are just being accrued at an unprecedented rate.   00;07;46;17 - 00;08;28;21 So there are just so much data now for us to potentially access and analyze. There's always this concern about proper safeguard of individual privacy. And through our work, we also became very appreciative of other considerations, for example, the fishery responsibilities of the delivery systems and payers to protect patient data and make sure that they are used properly. So you mentioned the recent changes, including in data management, ensuring policy, which I think are moving us in the right direction.   00;08;28;26 - 00;08;56;23 But if you look closer at the NIH policy, it makes special considerations for proprietary data. So I would say that we have made some progress, but access to proprietary data remains very challenging. And the FDA, the NIH policy doesn't actually fully resolve that yet. When you think about the people who do make that argument for limited data sharing, they do mostly talk about what you just said about patient privacy.   00;08;56;23 - 00;09;25;20 IT proprietary data. Pharma is especially sensitive to that, I would imagine. So how do we incentivize the reluctant how can we ease their risks and concerns or can we? Yeah, it's a tough question. I think that this require a multi-pronged approach and I can only comment on some aspects of this. So I would say that at least based on our experience, the willingness or ability to share data often depends on the purpose.   00;09;25;23 - 00;09;55;29 That is, why do we need the data? Many data partners participate in Sentinel because of its public health mission, and our consideration is how would the data be used again, Is there proper safeguard of patient privacy and institutional interest? There are other ways to share data. For example, instead of asking the data to come to us, we can send analysis to where the data is.   00;09;56;06 - 00;10;34;22 And that is actually the principle follow by federated system like Sentinel. So we don't pull the data centrally. We send an analysis to the data partners and only get back what we need it. And it's usually in the summary level format. So that actually encourages more data sharing instead of less sharing. I would say that recent advances in some domains, such as tokenization and encryption, might also reduce some concern about a data sharing, a patient privacy concerns in academic settings.   00;10;34;29 - 00;11;24;26 We've been talking a lot about days, for example, for individual who collect the data and the people I propose to offer them authorship or proper acknowledgment if they are willing to share their data. But that is not sufficient in many cases outside of academic settings. If you look at what is happening in the past ten years or so, there are now a lot of what people call data aggregators that are able to bring together data from multiple delivery systems or health plans, and they seem to be able to develop a pretty effective model to convince the data provider to share that data in some way.   00;11;24;29 - 00;11;55;28 And a way to do that could be to help these data providers to manage their data more efficiently or to help them identify individuals who might be eligible for clinical trials. More quickly. So there are some incentives that we could think of to allow people to to share that data more openly but personally, I think that scientific data should be considered public good and hopefully that will become a reality one day.   00;11;56;00 - 00;12;23;21 Yeah, that's really interesting because it sounds like it's both a combination of centralized and decentralized tactics in terms of of data sharing and gathering. Why is it so important to use unstructured data in pharmacoepidemiology studies? And does NLP really make a huge difference in overcoming the limitations and extracting that data? So in the past, I think that that's true.   00;12;23;21 - 00;12;58;07 Now, many pharmaco epidemiologic studies rely on data. They are not collected for research purposes. So we use a lot of medical claims, data that are maintained by payers. We use each our data that are maintained by delivery systems. So this data are not created for research purposes and much of this data, at least for claim, is data stored in structured format using established coding systems like ICD ten.   00;12;58;10 - 00;13;39;06 Coding system and structured data sometimes are not granular enough for a given drug safety study and certain data or set of variables that are required for claims reimbursements or other business purposes might not be collected at all. And people felt that, well, maybe the information that we need could be extracted from unstructured data because as part of clinical care, the physicians or nurse practitioner or the health care provider might include that information in the notes, but use user data also pretty messy, especially that unstructured data.   00;13;39;08 - 00;14;05;25 So instead of going through the unstructured notes manually to extract this information manually, technique by natural language processing could help us do this task much more efficiently so that we can mind a larger model of unstructured data. Well, obviously, when it comes to real world evidence, you're a fan. Tell us what excites you about using it to complement clinical research.   00;14;05;25 - 00;14;42;07 Get us more evidence based insights and help practitioners make better decisions. Yeah, that's a great question. Yes, I'm a fan of so I personally don't quite like the dichotomy between conventional, randomized, controlled trial and real world data studies because they actually sit along a continuum. But is true that conventional randomized trials cannot address all the questions in clinical practice.   00;14;42;09 - 00;15;30;17 So that's where real data and real data studies come in, because real data like we discussed come from clinical practice. So they capture what happens in day to day clinical practice. So if we are thoughtful enough, we will be able to analyze the data properly and generate useful information to fill some of the knowledge gap. The truth is we have been using real data throughout the lifecycle of medical product development for many years now, ranging from understanding the natural history or burden of diseases to using real data as controls for single arm trials, and that we have been doing this before the term real data became popular.   00;15;30;19 - 00;15;57;11 So I see real data to complement what we could do in conventional randomized trials. So real data studies don't replace clinical trials. I see them to be complementary, and real data studies sometimes are the only way for us to get certain evidence. We already talked about Mosaic and LP that project, but I kind of want to go a little deeper with it.   00;15;57;11 - 00;16;42;02 The idea is to tackle the challenges of using link data structured and unstructured at scale. Tell us about a use case for that project and why it was chosen for this project. We actually, Cerner proposed to use the association between Montelukast, which is an asthma drug and neuropsychiatric events as a motivating example. It is also important to note that the project is not designed to answer this particular safety question, because if you look at the label of Montelukast, there's also already a box warning on neuropsychiatric events.   00;16;42;02 - 00;17;18;26 So FDA already has some knowledge about this being a potential adverse event associated with the medication. The reason why or recalls is has proposed this project was because we actually did look at this association in a previous sentinel study that only used structured data, although the study provided provided some very useful information. We also recognized that certain information that we needed was available in such a data, but may be available in unstructured data.   00;17;18;28 - 00;17;42;18 So if we are able to get more data from unstructured data, we might be able to understand this association better. So that's why this motivating example was chosen. Well, this is an Oracle podcast and Oracle is involved in Mosaic, so I think it's fair to ask you about the technology challenges that are involved in what you're trying to do.   00;17;42;19 - 00;18;17;24 What does the technology have to be able to do for you to experience success? So Mosaic in LP is I was at a very ambitious project because it is using an LP to extract multiple variables that are important for the study. That includes the study outcome, which when you look at it, is a composite of multiple clinical outcomes and it's also trying to extract important covariates that could help us reduce the bias associated with real data study.   00;18;17;26 - 00;19;01;24 So I think technology comes in well is powerful in many ways. First, thanks to technology, the project is able to access very large amount of data from millions of patients who seek care in more than 100 healthcare delivery systems across the country. So this was hard to imagine maybe ten or 15 years ago. But now we have access to lots and lots of data at our fingertips because of advances in technology, because of the large amount and the complexity of the data methods side and LP becomes even more important.   00;19;01;26 - 00;19;33;19 And for this project, we are also particularly interested in whether an LP algorithm developed in one year trial system could be applied to another system, which has been a challenge in our field because each year our system is created very differently. So one, an algorithm that works in one system might not work in another. So we are hoping that through advanced methods and technology, we will be able to address this problem.   00;19;33;21 - 00;19;57;15 So without this technology advances, we might not be able to do this study as efficiently as we could all So the task might might not be possible. So where are we going with this? I mean, let's say the project is a success. What will that mean in terms of the FDA's goals and how NLP gets applied in medical therapeutics safety surveillance?   00;19;57;18 - 00;20;38;03 The hope is that Sentinel system can answer even more questions than it can address today. And the way that we are trying to accomplish that is to see whether or how this complex, unstructured data, we combine it with advanced analytic methods can help us answer questions that could not be addressed by structured data alone. I think through this project we also learned a lot about how the challenges associated with analyzing a very large amount of data from multiple sources.   00;20;38;06 - 00;21;11;14 Again, service data is compiled from more than 100 systems, so it is big but also very complex. And in many of our studies we really need that large amount of data just to be able to answer the question because we may be focusing on rare exposures or real come. So you really need to start with very large from our data just to get to maybe the ten patients that are taking a medication.   00;21;11;17 - 00;21;44;15 And what you learn with Mosaic, can that get applied to addressing other public health issues like disparate ease and asthma diagnosis and treatment, especially when you think about diverse groups? Yeah, that's a great question. So is the project is not designed to address these important questions, but if we are able to better understand the completeness of social drivers of health in these data sources, then we will be able to leverage this data to answer these questions in the future.   00;21;44;18 - 00;22;04;26 I think about how a project like this gets a evaluated at various steps along the way. I guess that's my question. How I mean, what what methods are used to ensure the validity of real world evidence? So the good news is in the past few decades we have been using real data, even though we might not be using the term.   00;22;04;28 - 00;22;36;22 So there's been a lot of progress in the field to improve the validity of Real-World Data studies. So we now have a pretty good framework to identify fit for purpose data, and we also have very good understanding of appropriate design and analytic methods. So to target trial emulation and propensity score methods. So this project and many other projects in Sentinel are following this principle.   00;22;36;24 - 00;23;14;03 And one thing to also note that this project is also following the overall sentinel principle in transparency. So everything we do will be in the public domain to allow people to reproduce, so replicate the analysis. So the protocol is available in public domain, and when we are done with the study, everything will be made publicly available. So that's one way to make sure that the the work at least is reproducible or replicable.   00;23;14;05 - 00;23;43;00 And through that process, we hope to be able to improve the validity of this study. And what about comparisons? How do you compare the results from different data sources like claims data, structured data? You know, I extracted unstructured data, all of that. How was that done, the comparisons? So if you're talking about the Mosaic and LP study, so we have a pretty structured approach to address that question.   00;23;43;02 - 00;24;13;14 So we are using this proven principle of changing one thing and keeping everything else fixed to see what happens. So the project will start by using only claims data to replicate the previously done Sentinel study. And then we are going to add on such data to see whether the results are different. And then we add on an LP extract that unstructured data one at a time to see whether the results change.   00;24;13;21 - 00;24;40;24 So by fixing everything else to be constant and changing one thing, we'll be able to assess the added value of each how data, both structure and structure. And that's how we are going to do it within the Mosaic and LP study. And then what about scalability? How would you make sure the NLP models that you develop are scalable and transportable across all these different health systems of which there are many?   00;24;40;27 - 00;25;10;10 Yeah. The question again is about transport ability. So one thing that is unique about this study, as we briefly discussed earlier, was that the the survey yesterday to actually come from multiple healthcare systems. So the end up models that we are developing will be trained in tune on a sample of patients from this system and not from a single hospital network.   00;25;10;10 - 00;25;42;18 So at the development phase, we are already taking into account the potential diversity of different delivery system. And as part of this project, we also include another delivery system to apply and test the method as part of the transport ability assessment. So we are doing that to make sure that the LPI models that we are developing for this project will be useful for other system as well.   00;25;42;20 - 00;26;12;29 Unknown There is a larger question about computational resources, so that will be the issue that would still need to be addressed because a train and tuning this and NLP models within such a huge amount of data requires a lot of computing resources. So that is something that we could only partially address in our study. But if we want to apply or do the same thing in our system, that would be something to consider.   00;26;13;02 - 00;26;43;13 We talked a little bit about the collaboration with your tech partner, but these things usually have so many stakeholders and disciplines and silos. Tell us first why collaboration is a good thing and unavoidable anyway, and then what the challenges of collaboration are. Maybe some tips on how to best make them work. The problems that we face, at least many of the problems that I face quite complex and they require expertise from multiple domains.   00;26;43;13 - 00;27;18;19 So that calls for collaboration from multiple stakeholders. And we always have our blind spots. So we only see things in a certain way and we always miss things. So that's why I think collaboration is important. But it's really hard sometimes because we all have our priorities and perspectives and sometimes they don't align. And I also learned throughout the years that we don't communicate enough and we may also not have time to communicate or we may be under pressure to deliver.   00;27;18;21 - 00;27;47;21 So all of that sort of contribute to the challenges of collaborating effectively, especially when you collaborate across disciplines, because we might be using different languages to mean the same thing or use the same term to describe different things. So even though we can all speak the same language less English, we might not be talking about the same thing and not communicate at all.   00;27;47;21 - 00;28;17;25 Because because we are using different joggers and terminology. So that has been tough. But I think we are getting better. And so I think that it is for us within the center of operation center, we try to communicate honestly and respectfully and we try to understand different perspectives and we try to find common ground. And but I think ultimately what brings us together is that we have a shared common goal.   00;28;17;27 - 00;28;44;17 A lot of the work that we do. So for music and NLP, we are all trying to answer the same question, which is that how do we use unstructured data and advanced analytic methods to answer safety question? So once we apply on this common goal, things become easier because we start to understand each other better or be able to communicate more effectively.   00;28;44;19 - 00;29;19;16 Just out of curiosity, what are the different stakeholders involved in Mosaic? Who falls on the roster? we have people from different disciplines, so we have experts in natural language processing and artificial intelligence. We have epidemiologists, both statisticians, clinicians, we experts in psychiatric conditions and respiratory disease. We have data scientists, we have engineers, we have project managers. So it's a very big group of individuals with different expertise in this project.   00;29;19;18 - 00;29;46;14 Well, you probably noticed Oracle's really thrown itself into and committed huge resources to health and life sciences. Things got really exciting with the acquisition of Cerner and Cerner and Visa. What's Oracle doing right and what do you think it should be doing to make itself even more valuable in health and life sciences? Well, this is a great but very difficult question, so I cannot comment too much what Oracle is doing or will be doing.   00;29;46;17 - 00;30;23;06 But I can say more generally that there have been a number of technology companies that have tried to foray into health or life sciences. I would say with mixed results. And one reason is that our health care system remains highly fragmented and complex, so it takes a lot of energy to break the status quo. So you probably know that we were one of the last countries in the world to transition from ICD nine to ICD ten coding system, and we are soon going to move into the ICD 11 system.   00;30;23;06 - 00;31;00;05 So I'll be interested to see whether the US is ready for that. And that again, is maybe a reflection of just how complex and fragmented our system is and disruptive innovation and I think are great, but they may or may not translate into successes when they applied to health care. That is not to say tempesta mistake. I'm actually pretty optimistic that the perspectives and solutions and ideas brought by technology companies could help us solve a lot of problems that we have today.   00;31;00;07 - 00;31;31;26 But I think that it will be good to engage people who will be struggling with these issues early on and to work together with them to develop solutions that are not just good on paper, but also feasible in practice. So at least in my very limited experience, we have seen some very cool technology that ended up not being useful for health care just because it's very hard to change what people have been doing.   00;31;31;28 - 00;31;56;09 So again, disruptive innovations are good, but sometimes it's just very hard to adopt, at least not quickly enough for for us to see meaningful changes. Yeah, that's really fascinating. It's, you know, it is disruptive innovation, but it's not always applicable to the to the goals you're pursuing. But it does feel like technology where that's concerned, the future is coming at us faster and faster.   00;31;56;11 - 00;32;32;21 So what are the technologies that are most interesting to you? Is it A.I. or what big advances in public health do you see coming? Maybe sooner than we thought. Yeah. Yeah. You know, I feel like you said some of this came too fast. Like, I wish I. And closer to retirement, I don't worry about this. But so even though I say disruptive innovation sometime might not work in health care, but I will say generative A.I. seems to be a recent exception.   00;32;32;24 - 00;33;10;14 So I would say that generative is definitely on the list of things that surprised me in a very nice way. I will also say that the continue fast accrual of better real data is also something that excites me and the continue recognition or increased recognition of the potential real data of. It's also something that I think is good to have for things that came sooner than I found it again, generative.   00;33;10;19 - 00;33;44;13 AI So if you ask me when, we'll be ready for generally. AI Last year or two years ago, I would say not yet, but now we in the era where everything seems possible. So I remain extremely optimistic about generative in some of these last language models that will help us analyze unstructured data even more efficiently. Well, therein it's deeply fascinating and exciting stuff.   00;33;44;14 - 00;34;10;27 Thanks again for letting me pester you with these questions. If our listeners want to learn more about Sentinel, Operation Center or Mosaic or you, what's the best way for them to do that? So Sentinel has a poverty website where we post everything that we do. So is Sentinel initiative dot org. So I am a member of the Department of Population Medicine at Harvard Medical School.   00;34;10;29 - 00;35;00;16 So our website's population is a thought, but these would be two places that would be very informative for audience. Who wants to know more? All right. We appreciate that. And to our listeners, go ahead and subscribe to the show. Feel free to listen to past episodes because they are free. There's a lot to learn here. And if you want to learn more about how Oracle can accelerate your own life sciences research, just go to Oracle dot com slash life dash sciences and we'll see you next time on Research in Action.

How do clinical research funders operate? Why do patient-centered outcomes matter so much and improve the quality of research? And how is patient-led research being applied to clinical care? We will learn all that and more in this episode of Research in Action with Greg Martin, Chief Officer for Engagement, Dissemination, and Implementation at the Patient-Centered Outcomes Research Institute (PCORI). www.oracle.com/health www.oracle.com/life  www.pcori.org/

Ensuring 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 ensure its continued use in the field.Tune in to find out:●      How AI and ML are being used today in pharmacovigilance processes●     Why a mindset change is necessary to make full use of AI/ML in pharmacovigilance●      How we may best move forward to implement AI/ML into healthcare. Want to know more? To know more about how AI and ML are being used in pharmacovigilance currently, read this scoping review.To know more about future trends of the use of AI in Biopharma, read this Accenture survey.Despite there being major interest in ML and AI to do more than task automation, there are a number of barriers to its implementation in healthcare. Check out this future-focused paper on the use of AI/ML in pharmacovigilance that details how to utilise it to its fullest potential.A mindset shift is necessary in terms of how we think about data, in terms of sharing, how to generate data required to effectively train AI/ML models.A validation framework must be developed for AI-based pharmacovigilance systems. One suggestion is to do so using a risk-based approach.While there is much interest in using recently developed AI technologies such as chatGPT, preliminary studies like this one suggest that the technology has a ways to go to be useful in pharmacovigilance.The World Health Organization have published an extensive guideline on the ethics and governance of AI for health.Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Look-alike medicines, unclear communication and distractions during administration – medication errors may occur for many different reasons. They all have in common that they are unintended mistakes in the drug treatment process that may or may not lead to patient harm. In this episode Ghita Benabdallah and Loubna Alj from the national pharmacovigilance centre of Morocco, and Alem Zekarias from Uppsala Monitoring Centre discuss how we can prevent medication errors from occurring – and, when they do occur, make sure that they are reported as such. Tune in to find out:What are the most common causes for medication errors?How should strategies for preventing medication errors be devised? How does the assessment of suspected medication error reports differ from “regular” ADR signal assessment?What can be done to encourage healthcare professionals to report medication errors?Want to know more?In March 2024, WHO published this systematic review of the global burden of preventable medication-related harm in healthcare.According to this 2021 article in BMJ, an estimated 237 million medication errors occur in England every year. Avoidable adverse drug events were calculated to cost the National Health Service an annual sum of GBP 98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths. This 2012 meta-analysis confirmed what had been suggested in several observational studies: that preventable adverse drug reactions are a significant healthcare burden.The European Medicines Agency (EMA) has a dedicated webpage with recommendations, guidelines, legal requirements and a good practice guide on medication errors. Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Serious 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 in the episode:Quality of reporting of adverse events in clinical trials of COVID-19 drugs: systematic reviewPsychiatric disorders and hydroxychloroquine for COVID-19: a VigiBase studyHepatic disorders with the use of remdesivir for COVID-19Serious bradycardia and remdesivir for COVID-19: a new safety concernOxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia: a missed opportunity for a rapid return of experienceAtypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine: data from the French network of regional pharmacovigilance centresTeaching pharmacovigilance to French medical students during the COVID-19 pandemic: interest of distance learning clinical reasoning sessionsIf you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:Reforming pharmacovigilance educationLessons in pandemic pharmacovigilanceIntuition in pharmacovigilanceJoin the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI).Tune in to find out:Who is most at risk of developing DILIHow to diagnose the condition and control the damageHow to assess case reports of DILIWant to know more?This infographic in Nature Reviews nicely summarises the mechanisms, diagnosis, and management of drug-induced liver injury.In this report, the Council for International Organizations of Medical Sciences provides a global perspective on DILI detection, susceptibility factors, outcomes, and more.In this Drug Safety article, industry representatives outline how to identify, mitigate, and communicate the risk of DILI during drug development. The PRO-EURO DILI NETWORK coordinates research efforts on DILI across Europe and provides a forum to exchange knowledge and training on the topic. Similar initiatives include the Spanish DILI Registry and the Latin American DILI Network.The free online tool LiverTox contains up-to-date information on drug-induced liver injury for medicines and herbal products.To learn more about post-marketing surveillance and clinical care of DILI, check out Uppsala Monitoring Centre's free online course on the topic.For more on the clustering algorithm vigiGroup, revisit this interview with UMC scientists Jim Barrett and Joe Mitchell.Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

How, and to whom, should you disclose your MS at your job? And if you decide to disclose, is that information confidential? What does reasonable accommodation mean? If you need a day or two to bounce back after an infusion, is that part of your PTO? And what do you do when you no longer have days off available? If you're living with MS and you're employed, you absolutely need to know and understand your rights in the workplace.  MS Navigator Christina Forster joins me to answer these questions and more as she shines a bright light on your rights in the workplace. I'll also remind you why I consider the MS Navigator program to be the gold standard when it comes to customized, one-on-one problem solving and support for anyone affected by MS. (And did I mention there's no charge???) I hear your questions, so we're taking a moment to review what the RealTalk MS show notes are all about, and where to find them. We're sharing study results that show a wheat-free diet may reduce MS severity (and it's not about the gluten!) We'll tell you about a call by experts to adopt a new framework for describing Parkinson's Disease (and we'll explain why that's relevant to the MS community) Scientists have identified 4 variant genes that place an individual taking some common MS disease-modifying therapies at higher risk of contracting PML. There's a test for that, and we'll tell you how to have that genetic testing done at no cost. We're talking about research that uncovered new details about how cells in the central nervous system communicate with the cells that produce myelin. And we'll tell you why zebrafish are the key to this research. And we're sharing a change in strategy for treating MS contained in the updated guidelines published by the Spanish Society of Neurology  We have a lot to talk about! Are you ready for RealTalk MS??! This Week: Successfully navigating the health insurance maze  :22 Why the MS Navigators are the gold standard when it comes to support for people affected by MS  :56 Everything you need to know about the RealTalk MS show notes  2:12 STUDY: A wheat-free diet may reduce MS severity  5:28 Experts call for a new framework for describing Parkinson's Disease  8:31 A test to determine who is at high risk for contracting PML is available...at no cost  11:36 STUDY: Researchers identify specific proteins and signals involved in myelin formation in zebrafish  14:08 The Spanish Society of Neurology has updated its guidelines for treating MS  15:42 MS Navigator Christina Forster discusses your rights in the workplace   19:35 Share this episode  30:37 Have you downloaded the free RealTalk MS app?  30:57 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/335 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Contact an MS Navigator Phone: 1-800-344-4867 Web via chat: https://nationalmssociety.org Email: contactusnmss@nmss.org STUDY: Attenuation of Immune Activation in Patients with Multiple Sclerosis on a Wheat-Reduced Diet: A Pilot Crossover Study  https://journals.sagepub.com/doi/10.1177/17562864231170928 Progressive Multifocal Leukoencephalopathy Genetic Risk Variants for Pharmacovigilance of Immunosuppressive Therapies https://www.researchgate.net/publication/371965313_OPEN_ACCESS_EDITED_BY_Progressive_multifocal_leukoencephalopathy_genetic_risk_variants_for_pharmacovigilance_of_immunosuppressive_therapies No Cost PML Risk Genetic Test https://pmlrisktest.org STUDY: Synaptic Input and Ca2+ Activity in Zebrafish Oligdodendrocyte Precursor Cells Contribute to Myelin Sheath Formation https://www.nature.com/articles/s41593-023-01553-8 Consensus Statement of the Spanish Society of Neurology on the Treatment of Multiple Sclerosis and Holistic Patient Management in 2023 https://www.sciencedirect.com/science/article/pii/S2173580824000191 Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 335 Guest: Christina Forster Privacy Policy

In this episode of "Queens of Quality," hosts Michelleanne, Jen, and guest Steve Thompson delve deeper into the ethical implications of AI in life sciences. They emphasize the necessity of an Algorithm Review Board (ARB) to oversee the ethical use of AI in clinical trials and beyond. Acknowledging the rapid evolution of technology and its complex application in healthcare, they stress the importance of collaboration and diverse representation to ensure ethical practices.Tune in!During this episode, you will learn about;00:31 Introduction and Welcome Back00:40 Discussion on AI and Clinical Trials01:17 The Concept of Algorithm Review Board01:44 The Evolution and Impact of Technology02:35 The Synthetic Patient Concept04:10 The Need for Ethical Standards in AI05:42 The Role of Institutional Review Boards08:49 The Importance of Diverse Representation10:48 The Idea of Algorithm Review Board10:59 The Need for Collaboration and Inclusion12:15 The Risks of Misusing AI in Medicine20:26 The Importance of Preventative Measures21:12 Call to Action for Audience Participation24:30 Conclusion and Invitation for Future Discussions Love the show? Subscribe, Rate, Review, Like, and Share!Let's Connect!Connect with Steve ThompsonLinkedIn: https://www.linkedin.com/in/stevethompsonsocal/Connect with Queens of Quality;Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: hello@metisconsultingservices.com

What 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.Through 14 chapters and 13 special interest groups, the society works to enhance the safe and proper use of medicines across countries. Their latest annual meeting took place in Bali, Indonesia in November 2023, while the next one will take place in Montreal, Canada in October 2024. To learn more about ISoP's activities in patient engagement and pharmacogenomics, listen to these episodes from the Drug Safety Matters archive:Empowering patients as partnersTailoring drug therapy to your genesJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

In this engaging episode of "Queens of Quality," Michelleanne welcomes Steve Thompson to delve into the realm of ethical AI in life sciences. They explore the excitement and challenges surrounding AI's evolution, emphasizing the critical need for an ethical compass in its application. With insightful discussions on bias, data integrity, and the multidisciplinary approach necessary for success, Steve and Michelleanne highlight the intricate balance between technological advancement and ethical responsibility. Their conversation teases a promising solution, promising a deeper exploration in the next episode.Tune in!During this episode, you will learn about;0:00:32 - Introduction and Guest Introduction (Steve Thompson) - Discussing the Importance of Ethical AI0:01:47 - Guest's Background and Journey into AI0:02:11 - The Current State and Future of AI0:03:22 - The Ethical Dilemmas in AI0:05:34 - The Importance of Continuous Improvement in AI0:11:35 - The Challenges of Creating Synthetic Patients0:13:32 - The Role of AI in Risk Management0:18:48 - The Importance of Multidisciplinary Teams in AI0:24:30 - The Ethical Considerations in AI0:28:48 - Conclusion and Teaser for Next Episode      Love the show? Subscribe, Rate, Review, Like, and Share! Let's Connect! Connect with Steve ThompsonLinkedIn: https://www.linkedin.com/in/stevethompsonsocal/Connect with Queens of Quality;Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: hello@metisconsultingservices.com

To mark #MedSafetyWeek, which took place from 6–12 November, we're releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedha from the Therapeutic Information and Pharmacovigilance Centre in Namibia – about what makes a successful campaign.Tune in to find out:Why you should always tailor your communication strategy to your settingHow to deal with the financial, cultural, and logistical challenges of campaign planningWhat to keep in mind if you are new to #MedSafetyWeekWant to know more?You can read a summary of this episode on the Uppsala Reports news site.To learn more about #MedSafetyWeek, check out the hashtag online and visit the campaign website, where you will also find free social media materials in several languages.This is the second of a two-part episode on pharmacovigilance communication campaigns. Listen to the first part here.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

To mark #MedSafetyWeek, which takes place from 6–12 November, we're releasing a special two-part episode on pharmacovigilance communication campaigns. In this first part, we speak to Mitul Jadeja from the Medicines and Healthcare products Regulatory Agency in the UK about under-reporting and how initiatives like #MedSafetyWeek can help draw attention to medicines safety.Tune in to find out:Why under-reporting plagues all pharmacovigilance systemsWhat regulators can do to encourage people to report side effectsWhy we need reports from both patients and healthcare professionalsWant to know more? Here are the studies cited in the episode:A BMJ study in 2022 measured the burden and associated cost of adverse drug reactions, polypharmacy and multimorbidity at a hospital in the UK.In 1976, Inman proposed a theoretical model, known as the ‘seven deadly sins', to explain why healthcare professionals fail to report adverse drug reactions. This recent systematic review in Drug Safety expands on that. The SCOPE Joint Action project aimed to enhance pharmacovigilance in the EU and delivered practical guidance for regulators.The first UK study to compare Yellow Card reports from patients and healthcare professionals was published in 2012.To join the #MedSafetyWeek campaign next week, follow the hashtag online and check out the campaign website for free social media materials.Finally, don't forget to tune in on 13 November for part 2 of this podcast, where we'll hear from #MedSafetyWeek advocates in Iraq, Luxembourg, and Namibia about their experience with the campaign. Read a preview of the conversation on Uppsala Reports.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

The FDA Group's CEO, Nick Capman, sits down with Steve Knowles, MB.BS, M.R.C.P., M.F.P.M., Chief Medical Officer at Halozyme, a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. They discuss advancements in drug delivery technology and the role of leadership in fostering innovation and addressing challenges in this field. Discussion points include: » Dr. Knowles's transition from a physician in the UK to Chief Medical Officer at Halozyme in San Diego. » The evolution in drug delivery systems, such as the shift from hospital-based treatments to self-administration of drugs at home and the introduction of auto-injectors and on-body devices for efficient, patient-friendly drug administration. » Addressing human factors and compliance to ensure products are user-friendly—and the importance of human factor studies in product development. » The advantages of subcutaneous drug delivery, including reduced side effects, improved pharmacokinetic profiles, and patient convenience. » How Halozyme's one-team approach fosters a culture of curiosity, flexibility, and feedback. » Aligning individual and organizational goals to drive innovation. Dr. Knowles has deep pharmacovigilance and medical affairs experience gained over a career spanning almost 20 years. Dr. Knowles joined Halozyme in January 2018 as Vice President, Drug Safety & Pharmacovigilance. He is responsible for the Medical, Regulatory and Drug Safety organizations. Prior to Halozyme, Dr. Knowles served as Senior Medical Director, Global Patient Safety and Benefit Risk Management at Eli Lilly & Co. where he led the global safety physician/scientist group responsible for overseeing the safety profiles and benefit risk management of medicines across all therapeutic areas and phases of development and supported numerous BLA and MAA submissions. During his 16 years at Lilly, he held positions in Medical Affairs and from 2005 to 2017 he held roles of increasing responsibility within Global Patient Safety. Prior to these roles, Dr. Knowles spent more than 17 years in clinical practice in the UK in both hospital-based and general practice roles. Dr. Knowles received his Bachelor of Medicine and Surgery degrees (MB.BS) from the University of Newcastle Upon Tyne and is a Member of the Royal College of Physicians (MRCP) and a Member of the Faculty of Pharmaceutical Medicine (MFPM). Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

Herbal 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 herbals are rarely discussedHow to encourage safety data collection for herbalsHow to improve herbal nomenclature and regulationWant to know more?Here are some of the resources cited in the episode:Underreporting of adverse reactions to herbal remedies is driven by our attitude towards herbals themselves, but also by a lack of training on herbal medicines in healthcare curricula.It is possible to safely use herbal medicines together with other medicines, but we must keep in mind some critical issues related to their interaction.Simple videos can dramatically increase public awareness of ADR reporting schemes.Kew Gardens' Medicinal Plant Names Services offers a systematic overview of medicinal plants and their accepted scientific names.The American Botanical Council suggests methods to uncover attempts to adulterate plant extracts.For a comprehensive overview of herbal pharmacovigilance, check out this recent book by Joanne Barnes and colleagues covering advances, challenges, and international perspectives in the field.For more on Daniele's scoping review of signals or the thorny nomenclature of medicinal plants, listen to these episodes from the Drug Safety Matters archive: The evidence for signalsNavigating the plant names jungleFinally, don't forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

A 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:How regulators and healthcare professionals can effectively engage patientsHow patients can get involved in drug safety monitoringWhat the pharmacovigilance community learned from the valproate caseWant to know more?In 2022, the Council for International Organizations of Medical Sciences (CIOMS) published a comprehensive report on patient involvement in the development, regulation and safe use of medicines. They also recorded a webinar to summarise the report's main conclusions.The International Society of Pharmacovigilance (ISoP) runs a patient engagement group to advance patient involvement in the safety monitoring of medicines.The Valproate toolkit, developed by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), supports healthcare professionals in advising women of childbearing age about the risks and benefits of valproate therapy.PatientsLikeMe is a digital platform where patients can share personal health stories, connect to peers, and learn about different conditions and treatments.For more on patient engagement and communication, check out these episodes from the Drug Safety Matters archive:Why we should listen to patientsThe challenge of rare diseasesHow to talk about risksFinally, don't forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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

“The way I approach patient education conversations is to discuss it, address it, but not to emphasize it. I really like to focus on what the drug is. I mention if it's a biosimilar, I explain it, I give resources if they want it, but I really try to focus on the things that they're going to need to know in order to help be part of their care, but have readily available information to give them if they want more,” ONS affiliate member Rowena (Moe) Schwartz, PharmD, BCOP, professor of pharmacy practice at the University of Cincinnati in Ohio, told Jaime Weimer, MSN, RN, AGCNS-BC, AOCNS®, oncology clinical specialist at ONS during a discussion about the basics of biosimilars for nurses and patients. You can earn free NCPD contact hours after listening to this episode and completing the evaluation linked below. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 0.5 contact hours of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by February 3, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: The learner will report a gain in knowledge related to biosimilars. Episode Notes Complete this evaluation for free NCPD. ONS Biosimilars Learning Library ONS Voice articles: FDA Publishes Three New Biosimilars Resources for Healthcare Providers Nurses Will Forge New Territory With Biosimilars in Cancer Care Biosimilars, Oral Agents, and Drugs Targeted Genetic Mutations Are Creating a Paradigm Shift in Cancer Treatment Clinical Journal of Oncology Nursing articles: Approval Process: An Overview of Biosimilars in the Oncology Setting Nursing Roles: Clinical Implications Regarding Trends, Administration, and Education for Biosimilars in Oncology Practice Biosimilars: Exploring the History, Science, and Progress Clinical Trials: Nursing Roles During the Approval Process and Pharmacovigilance of Biosimilars American Society of Clinical Oncology Statement: Biosimilars in Oncology American Journal of Health-System Pharmacy article: Biosimilar Strategic Implementation at a Large Health System S. Food and Drug Administration (FDA) resources on biosimilars Nonproprietary Naming of Biological Products Purple Book Database of Licensed Biological Products Patient education Review and approval Hematology/Oncology Pharmacy Association International Society of Oncology Pharmacy Practitioners To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From Today's Episode “For generic products, it's important that they are the same as the brand-name product. The differences there tend to be only inactive ingredients. And for a biosimilar, it's very similar to that biologic, and it's supposed to have no clinically meaningful differences from the reference product.” Timestamp (TS) 06:46 “There was a lot of discussion about how would we identify when a patient got a biosimilar? A naming convention was implemented in 2017 that would help address understanding what particular drug a patient got at every point in care. The naming is done so that you have the core nonproprietary name, and then there's a four letter suffix added. . . . That naming convention was for all biologics that were approved that U.S. Food and Drug Administration naming guidance was implemented. And it's so that when that biologic comes out, if a biosimilar is ever approved, you would be able to differentiate.” TS 12:50 “The way I approach patient education conversations is to discuss it and address it but not to emphasize it. Because then I think it almost creates a question in the person's mind, ‘Is this as good?' We saw that with generics, we see that with biosimilars, and I really think that people need to know that this is the drug that you're using. They're pretty much overwhelmed, just even about the side effects. So I really like to focus on this is what the drug is, I mention if it's a biosimilar, I explain it, I give resources if they want it, but I really try to focus on the things that they're going to need to know in order to help be part of their care but have readily available information to give them if they want more.” TS 17:19 “As we get more of these products, as we use them, I think that the healthcare team is becoming more comfortable. And I think that is definitely felt by patients, caregivers, and families. As people get more comfortable with the data and the understanding of these, I think that will help patients and kind of flow over to the whole team.” TS 19:06

In this episode, Marta Boffito, MD, PhD, FRCP, and Jens D. Lundgren, MD, DMSc, address key considerations when evaluating antiretroviral therapy safety and tolerability in aging patients and those with possible cardiometabolic toxicities, including:Monitoring for cardiometabolic syndromes (eg, lipid panels, coronary artery calcification scores)Approaching antiretroviral-related weight gain in clinical practiceInterpreting results from RESPOND on cardiovascular risk with integrase strand transfer inhibitorsCollaborating with other specialties (eg, cardiologists, dietitians) to provide a multidisciplinary approach for managing comorbidities, including prevention and managementFaculty: Marta Boffito, MD, PhD, FRCPConsultant Physician/ProfessorHIV/ResearchChelsea and Westminster HospitalImperial College LondonLondon, United KingdomJens D. Lundgren, MD, DMScProfessorRigshospital, University of Copenhagen DirectorCentre of Excellence for Health, Immunity and Infection (CHIP)Rigshospital, University of CopenhagenCopenhagen, DenmarkLink to full program:http://bit.ly/3PM3nYeLink to downloadable slides: http://bit.ly/3WgYycz

“It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events,” Teresa Knoop, MSN, RN, AOCN®, nurse consultant in Nashville, TN, told Jaime Weimer, MSN, RN, AGCNS-BC, AOCNS®, oncology clinical specialist at ONS, during a conversation about the latest updates and approvals in oncology pharmacology. You can earn free NCPD contact hours after listening to this episode and completing the evaluation linked below. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 1 contact hour of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by January 13, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Participants will report an increase in knowledge related to the latest updates and approvals in oncology pharmacology. Episode Notes Complete this evaluation for free NCPD. Oncology Nursing Podcast Episode 126: Oncology Clinical Trials and Drug Development ONS Voice articles: S. Food and Drug Administration (FDA) updates Drug reference sheets Predictive and Diagnostic Biomarkers: Identifying Variants Helps Providers Tailor Cancer Surveillance Plans and Treatment Selection Help Patients Understand Biomarker Test Results and Clinical Trials Options Use ClinicalTrials.gov to Find the Right Cancer Research Studies for Your Patients ONS Biomarker Database ONS Genomics and Precision Oncology Learning Library ONS Immuno-Oncology Learning Library ONS Oral Anticancer Medication Learning Library ONS Biosimilars Learning Library ONS Seal of Approval Library Oral Chemotherapy Education Sheets Intravenous Cancer Treatment Education Sheets Clinical Journal of Oncology Nursing article: Clinical Trials: Nursing Roles During the Approval Process and Pharmacovigilance of Biosimilars FDA resources: Drug development and approval process Oncology/hematologic malignancies approval notifications Ongoing cancer accelerated approvals Verified clinical benefit cancer accelerated approvals Withdrawn cancer accelerated approvals Project Renewal Biosimilars review and approval Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) Project Livin' Label Oncology Center of Excellence To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From Today's Episode “Full approval through the Center for Drug Evaluation and Research (CDER) and FDA means that those drugs have gone through the laboratory testing, human clinical trial testing, and very extensive clinical trials to make sure that they are effective and that the benefits of those drugs outweigh the risks.” TS 02:28 “In 1992, CDER established a new program that would help these drugs get expedited, particularly in life-threatening or serious diseases like cancer. So they established an accelerated approval pathway for these promising therapies. They were hoping to shorten that period of time, and a number of our cancer-fighting drugs have come onto the market through this accelerated approval pathway.” TS 04:29 “When a drug gets an FDA approval, whether it be accelerated or final, then typically they get approved for one, possibly two indications on that first approval. But there are clinical trials ongoing in other diseases and in other indications. So we will then see drugs—after those clinical trials are conducted—taken to CDER for approval for that new indication.” TS 24:02 “The exciting thing for our patients is that new indications often treat more advanced cancers in which you discover a biomarker and could give patients potential treatment options when other options may have been exhausted.” TS 27:43 “It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events. Many of these drugs are designed so patients have to stay on them for extended periods of time, or at least they get the greatest benefit by staying on it for extended periods of time. Our patient education is key in helping patients do that.” TS 34:50 “In 2023, I think we will continue to see many new drugs that are approved. We will see new indications. I think particularly we will continue to see cellular therapy agents developed—we'll see them gain new indications. I would be willing to forecast that we're going to see more and more of specific immunomodulatory drugs or those antibody drug conjugates—all of those drugs that are designed to treat the cancer in a couple of different ways.” TS 37:29

Joining Chadi on today's show is Donald Harvey, PharmD, BCOP, FCCP, FHOPA, Winship Cancer Institute of Emory University. Dr. Harvey shares available career paths and how the pharmacist role has evolved over the years, how pharmacists continue to stay involved with patients after discharge, strategies he uses to help cancer patients adhere to oral oncolytics, and his “Call to Action” to improve such adherence – as co-planned by the FDA and ASCO and published in Journal of Clinical Oncology. The discussion is very detailed and enlightening; you won't want to miss it! View Dr. Harvey's publication “Call to Action for Improving Oral Anticancer Agent Adherence.” https://ascopubs.org/doi/10.1200/JCO.21.02529 Check out Chadi's website for all Healthcare Unfiltered episodes and other content. www.chadinabhan.com/ Watch all Healthcare Unfiltered episodes on Youtube. www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA