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Session 11: Managing Drug Risks – Regulatory Updates and Industry Perspectives
Session Chair(s)
Annette Stemhagen, DrPH, PhD, FISPE
Chief Science Officer
UBC, United States
Jo Wyeth, PharmD
Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
FDA, United States
Identifying and managing risks is fundamental to ensure safe and effective use of drug products. Approaches for Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) may evolve over time based on novel drug products entering the market, technology advances, and availability of new safety information. In this session, industry representatives will join with FDA and EMA to provide regulatory updates, address frequently asked questions, and share perspectives on the future direction for RMPs and REMS.
Learning Objective : At the conclusion of this session, participants should be able to:
- Integrate RMP and REMS regulatory update information into work practices
- Identify upcoming changes in RMP and REMS design, interpretation or analysis
- Synthesize perspectives to inform future REMS and RMP activities
Speaker(s)
Speaker
Cynthia LaCivita, PharmD
FDA, United States
Director, Division of Risk Management, OMEPRM, OSE, CDER
Speaker
Viola Macolic Sarinic, DrSc, MD, MSc
European Medicines Agency, Netherlands
PRAC Scientific Lead