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.
When: May 12, 2006, 9 am EDT/3 pm CEST/10 pm JST
Register
Presented by:
Dr. Enriqueta Vallejo-Yagüe is a pharmacist, pharmacoepidemiologist, and clinical researcher at the University of Zurich, focusing on health equity and person-centered care for non-communicable diseases. Her expertise spans real-world evidence, drug development, and health systems, integrating pharmacological and sociocultural factors. She holds leadership roles in the ISPE Health Equity SIG, ENCePP Health Equity Working Group, and previously with the Swiss Society for Gender Health, along with consulting for the WHO. She also led the development of the ETIE Framework.
Alexander Cole, DSc is a strategic enterprise leader in epidemiology and real-world evidence (RWE) with over two decades of experience across clinical development, safety, and regulatory functions, while championing health equity. As Executive Director and Global Head of Epidemiology and Real World Science at Alexion Pharmaceuticals, he built the company’s epidemiology function, established vendor partnerships, and oversees R&D governance. Previously at Genzyme, he directed global epidemiology and biostatistics for rare disease registries, with earlier experience in observational studies at Optum.
Description
There is increasing interest in improving equity and fairness in health research. In this webinar, we will introduce key related concepts and explore major determinants of health that can shape diagnosis, drug use, safety, and effectiveness. These include sex and gender, age, life stages, ethnicity and race, migration, socioeconomic status, education, health literacy, and health status and capabilities.
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
When: June 3, 2026, 9 am EDT/3 pm CEST/10 pm JST
Register
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
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
When: June 25, 2026
Time 09:00 AM EDT
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 ).
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
