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Session 8: REMS and RMP Effectiveness Evaluation: Industry and Regulatory Perspectives
Session Chair(s)
Jeremy Jokinen, PHD, MS
Vice President and Head Global Patient Safety
Argenx, United States
Annette Stemhagen, DrPH, PHD, FISPE
Chief Science Officer
UBC, United States
The measurement of the effectiveness of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS) remains an underdeveloped and underappreciated aspect of bringing a drug to market. This session will discuss various approaches to evaluating the effectiveness of these programs from both industry and regulator perspectives. Opportunities to advance the science of effectiveness measurement will be considered and approaches to incorporate patient-voice will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify effectiveness measure approaches that can be applied to risk minimization programs
- Identify similarities and differences in effectiveness evaluations between the US and the EU
- Discuss approaches to incorporate patient voice into effectiveness measures
Speaker(s)
Risk Minimization Program Evaluation: How Can we Advance the Science?
Meredith Yearsley Smith, PHD, MPA, FISPE
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Fellow and faculty member
Speaker
Janine Collins, MD, LLM
United BioSource Corporation, Switzerland
Executive Director Safety, Epidemiology , Registries and Risk Management
Logic Model: A Tool to Bridge REMS Design and Evaluation
Gita Toyserkani, PHARMD, MBA
Perspective Pharmacovigilance, United States
Regulatory Strategy Lead