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Session 8: REMS and RMP Effectiveness Evaluation: Industry and Regulatory Perspectives
Session Chair(s)
Jeremy Jokinen, MS
Vice President 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)
Meredith Yearsley Smith, MPA, FISPE
Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Risk Minimization Program Evaluation: How Can we Advance the Science?
Janine Collins, MD, LLM
Executive Director Safety, Epidemiology , Registries and Risk Management , United BioSource Corporation, Switzerland
Speaker
Gita Toyserkani, PHARMD, MBA
Regulatory Strategy Lead, Perspective Pharmacovigilance, United States
Logic Model: A Tool to Bridge REMS Design and Evaluation
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