Drug Safety on the Cutting Edge: What are the Implications of EMA's To-Be-Released Risk Minimisation Guidance on Pharmacoepidemiological Methods and Practice in Developed and Developing Countries?

Background
Advancing the science of risk minimisation program development and evaluation is one of the most dynamic areas of drug safety currently and is of high priority for regulators. It also carries enormous relevance for patient and public health, both in developed and developing countries alike. In a late-breaking development, the European Medicines Agency (EMA) has signaled that the finalization of its updated guidance on risk minimization programs is to be released in 2022 (Revision 3 of EU-GVP Module XVI). Revision 3 represents a major paradigm shift for EMA and advances new, more rigorous scientific standards for methods, data sources and evaluation research designs.

Objectives
--To describe the new EU-GVP Module XVI Revision 3 standards and discuss the implications for risk minimisation program design and evaluation in Europe and beyond;
--To highlight the new research methods, data sources and interdisciplinary collaborations that pharmacoepidemiologists will need in order to meet these new standards;
--To explore how ISPE can facilitate training and education to improve pharmacoepidemiologists' competencies in this area.

Description
This symposium will explore the implications of Revision 3 of EU-GVP Module XVI from the perspective of 4 key stakeholder sectors: 1) Regulators in developed countries (EMA); 2) industry drug safety practitioners; 3) academic-based pharmacoepidemiological researchers; and 4) regulators from developing countries.
a. Scientific Rigor of Risk Minimization Program

Design: Considerations for Participatory Methods. Presenter: Priya Bahri, Principal Scientific Officer, European Medicines Agency and Rapporteur for EU-GVP M XVI rev. 3 (15 min)
b. Practical implications of EU-GVP M XVI rev. 3 for industry: Designing and assessing risk minimization program effectiveness locally and globally. Presenter: Meredith Smith, Director of Risk Management, AstraZeneca plc (15 min)
c. Implications of EU-GVP M XVI rev. 3 for the practice of pharmacoepidemiology: Methods, data source selection and core skills and competencies. Presenter: Elaine Morrato, Dean, Parkinson School of Health Sciences & Public Health, Loyola University Chicago; Chair, ISPE BRACE SIG (15 min)
d. Practical Implications of EU-GVP M XVI rev. 3 for pharmacovigilance in developing countries. Presenter: Parthasarathi Gurumurthy, Director, Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority (15 min)
e. What is ISPE's role in helping pharmacoepidemiologists acquire new skills and competencies in this area? Panel discussion with audience Q&A (30 min)