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Monday June 15, 2026 4:00pm - 5:00pm EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-540-L04-P; CME 1.00; RN 1.00

This session shares US, EU and global expertise and experiences on methods to tailor risk minimization interventions and digital implementation support to special patient populations (e.g. female, young and older patients) in local contexts.

Learning Objectives

Describe needs and methods for tailoring risk minimization interventions to special patient populations; Recognize challenges and opportunities of digital support to implementing risk minimization interventions with examples; Discuss experiences from around the globe with localization of risk minimization interventions and reliance.

Chair

Priya Bahri, PHD

Speaker

Panelist
Shelley Gandhi, MS

Localisation of risk minimisation interventions – Low- and middle-income countries and global reliance
Jean-Christophe Delumeau, MD, PHD

Tailoring risk minimisation interventions - Applying implementation science and user-testing
Meredith Yearsley Smith, MPA, FISPE


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →
avatar for Delese Mimi Darko

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda
Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →
avatar for Jean-Christophe Delumeau

Jean-Christophe Delumeau

Senior Expert, Institute of Pharmacovigilance, Czech Republic
Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Partner & PV trainer, Eliquent Life Sciences, United Kingdom
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Meredith Yearsley Smith

Meredith Yearsley Smith

Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session

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