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ISPE Hosted Webinars

Scheduled Presentations and Recorded Highlights

The ISPE Education Committee guides the process of providing webinars to ISPE members and the global community. To keep webinars an active part of ISPE, please consider:

We also appreciate your help in sharing webinar updates with fellow members, whether that is reposting on social media or forwarding a webinar invitation.

Avoiding Immortal Time in Studies of Medication Use During Pregnancy

When: June 3, 2026, 9 am EDT/3 pm CEST/10 pm JST
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Description

Immortal time bias frequently invalidates real-world studies of medication use during pregnancy. This webinar moves beyond basics to focus on advanced recognition and mitigation of this bias in longitudinal databases. Through worked examples, speakers will demonstrate how to correctly align eligibility, time zero, and treatment assignments. We will cover practical methods—including time-varying exposure specification, explicit time anchoring, and design-based strategies—to ensure valid causal inference.

This session is designed for researchers familiar with observational methods seeking to refine their approach to time-related biases.

Learning Objectives

  1. Identify subtle immortal time biases in administrative perinatal data.
  2. Evaluate and apply robust study designs to eliminate time-related bias.
  3. Implement analytical strategies (e.g., time-varying exposure) to align treatment with eligibility.

Presented by

Mollie Wood, PhD, MPH is an assistant professor in Epidemiology at UNC Gillings School of Global Public Health. Her research focuses on the safety of medication use during pregnancy, specifically for chronic conditions like depression, migraine, and diabetes, combining expertise in reproductive epidemiology, pharmacoepidemiology, and methods.

Sonia Grandi, PhD is a Scientist and Assistant Professor at the Research Institute of the Hospital for Sick Children and University of Toronto. As a perinatal pharmacoepidemiologist, her research focuses on the safety of treatments for chronic cardiometabolic and immune-mediated conditions in pregnancy. She also specializes in causal inference methods using administrative health data.

Stephan Lanes, PhD, MPH is a Principal Scientist at Carelon Research, part of Elevance Health. He focuses on drug safety and the application of epidemiologic methods to health data in collaboration with industry, academic, and government partners

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Climate-Related Supply Chain Challenges and Drug Shortages: A Joint Webinar with ISPEpi, ISEE, ISoP, and ISPEngineering

When: June 18, 2026
Time: 9 am EDT/3 pm CEST/10 pm JST

Description

Climate change is no longer a distant threat to public health, as it is actively reshaping the global pharmaceutical supply chain. Extreme weather events, shifting environmental conditions, and ecosystem disruptions are increasingly jeopardizing the production, distribution, and availability of essential medicines. These pressures compound existing vulnerabilities and contribute to drug shortages that have direct, measurable impacts on patient health outcomes worldwide.

This webinar brings together leading voices across pharmacoepidemiology, environmental epidemiology, pharmacovigilance, and pharmaceutical engineering to define the problem space and chart a path forward. This webinar will convene experts from ISPEpi, ISEE, ISoP, and ISPEngineering, to facilitate interdisciplinary dialogue needed to address one of the most pressing challenges at the intersection of environmental change and public health.

We will elaborate on how these determinants influence health and treatment response, through biological mechanism (e.g., sex affecting PK/PD), or through social norms, discrimination, and barriers to healthcare or research participation.

Participants will be introduced to the ETIE (Explore, Tailor, Implement, Evaluate) framework and learn how to apply it to pharmacoepidemiologic and clinical studies. The ETIE framework provides a systematic approach to integrating equity considerations into study design, ultimately improving scientific rigor, fairness, and research relevance (https://onlinelibrary.wiley.com/doi/10.1002/pds.70175).

Learning Objectives

  • Describe the mechanisms by which climate change and environmental exposures can disrupt pharmaceutical supply chains
    Identify key structural vulnerabilities in global drug supply systems from engineering, epidemiological, and regulatory perspectives
  • Explain the concept of ecopharmacovigilance and its relevance to monitoring climate-related drug shortages
  • Summarize available evidence on the health impacts of drug shortages on patients and providers
  • Identify opportunities for interdisciplinary research and policy collaboration to strengthen supply chain resilience

Presented by

Trish Melton, PhD is Managing Director of Mime Solutions Ltd and a recognized leader in pharmaceutical engineering with over 25 years of ISPE membership and service. She is the recipient of the 2025 ISPE Richard B. Purdy Distinguished Achievement Award, in recognition of her long-term contributions to the industry. Dr. Melton has been deeply involved in ISPE's Guidance Documents Committee, serving as Chair from 2021 to 2024, and has contributed to the development of more than 80 ISPE Guidance Documents. Her work spans project management, sustainability, and pharmaceutical supply chain best practices, making her a leading voice on the structural and operational challenges facing the industry today.

Joseph Mitchell is an affiliated researcher at the Karolinska Institutet (KI), where his research focuses on the utility of pharmacovigilance in antibiotic resistance surveillance. He also works in pharmacovigilance and safety signal management. He is currently employed at ALK-Abelló. His broader research interests include One Health, ecopharmacovigilance, and causality assessment , areas that sit at the intersection of environmental change, drug safety, and public health, and are directly relevant to the challenges of climate-related drug shortages.

Robbie M. Parks PhD's research focuses on the intersections of climate change, public health, and equity, using quantitative methods to understand and address health impacts. He is a tenure-track Assistant Professor of Environmental Health Sciences at Columbia University's Mailman School of Public Health and an NIH NIEHS K99/R00 Fellow, with funding from NIH, the Wellcome Trust, NSF, and other sources; several of his lab's publications have been recognized as NIEHS papers of the year and month. He teaches multiple graduate courses at Columbia, leads advanced training programs in Bayesian modeling and climate-health attribution, and mentors trainees across all academic levels. His academic training includes a postdoctoral fellowship at Columbia's Earth Institute/Climate School, a PhD from Imperial College London, and a BA/MA in Physics from the University of Oxford. His work has been featured in major media outlets including The New Yorker, The New York Times, and National Geographic. He is a first-generation academic of Filipino heritage and a fellow of both the Agents of Change in Environmental Justice program and the National Academy of Sciences Frontiers of Science.

Soko Setoguchi, MD, DrPH is a cardiologist by training, board-certified internist, and epidemiologist, a Professor of Medicine, Director of Clinical Research Education, Director of Clinician Researcher Track, Medicine Residency Program, Department of Medicine, Rutgers Robert Wood Johnson Medical School (RWJMS) and Professor of Epidemiology at Rutgers School of Public Health. She is also Co-Director of the Master of Science in Clinical and Translational Science (MS-CTS) at Rutgers School of Graduate Studies. Dr. Setoguchi is recognized as an international leader in the field of pharmacoepidemiology and comparative effectiveness research studying the health effects of medications, medical devices, and other medical products in populations. She has authored more than 130 peer-reviewed papers in leading medical journals and has been funded by both federal and non-federal sources for her pharmacoepidemiology research program. Her research uses real world data to perform health services and outcomes research and comparative effectiveness research for medications and implantable medical devices in patients with chronic disease.

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The Fall of Vioxx (rofecoxib) and the Birth of Modern Pharmacoepidemiology

 

When: June 25, 2026
Time: 09:00 AM EDT

Description

During the early 2000's, a number of rigorous observational studies from several pharmaco-epi research groups including ours identified a higher risk of cardiovascular disease in patients taking rofecoxib compared to other NSAIDs, after controlling for possible confounders. Skeptics (including the drug's manufacturer) denied that this risk or any others could be rigorously demonstrated by population-based observational studies. In late 2004, a placebo-controlled RCT proved that the drug caused a more than two-fold elevation in the risk of myocardial infarction or stroke compared to placebo. Once one of the best-selling drugs in the world and used by over 20 million Americans and millions more worldwide over its five years on the market, Vioxx was immediately withdrawn by its manufacturer. Its trajectory led to a worldwide reassessment of how we track adverse events, the potential use of large health care datasets, and legislation to prevent a recurrence of another such unanticipated large-scale debacle of preventable adverse effects.

Learning Objectives

  1. How did the unexpected withdrawal of Vioxx in 2004 mark an inflection point in the public's perception of how the nation defines drug risks?
  2. What methodological and policy issues were illuminated by the rise and fall of Vioxx?
  3. What specific flaws did that event uncover, and what specific reforms did it trigger? (e.g., IOM and GAO reports, FDAAA legislation of 2007)

Presented by

Jerry Avorn, MD, FISPE, is a professor of medicine at Harvard Medical School and a senior internist in the Mass General Brigham health-care system. His group was among the first to use medication and clinical outcome claims data to study patterns of prescribing, adherence, outcomes, and adverse events. A past president of ISPE and a Fellow of the Society, he built a leading research center at Harvard to study medication use, outcomes, costs, and policies – the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) of the Department of Medicine at the Brigham and Women's Hospital. He also developed the educational outreach approach known as "academic detailing," providing non-commercial evidence-based information about medications to prescribers. One of the nation's most highly cited researchers, Dr. Avorn has written or cowritten over 600 papers in the medical literature as well as commentaries in JAMA, The New England Journal of Medicine, The New York Times, and The Washington Post. He is the author of Rethinking Medications: Truth, Power, and the Drugs You Take (Simon & Schuster, 2025 – www.RethinkMeds.info ).

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