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Virtual

Jan 26, 2021 9:45 AM - Jan 28, 2021 5:00 PM

(US Eastern Standard Time)

Pharmacovigilance and Risk Management Strategies Conference

Session 8: REMS and RMP Effectiveness Evaluation: Industry and Regulatory Perspectives

Session Chair(s)

Jeremy  Jokinen, PhD, MS

Jeremy Jokinen, PhD, MS

Vice President and Head, Safety Evidence and Sciences

Bristol-Myers Squibb Company, United States

Annette  Stemhagen, DrPH, PhD, FISPE

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  Smith, PhD, MPA, FISPE

Risk Minimization Program Evaluation: How Can we Advance the Science?

Meredith Smith, PhD, MPA, FISPE

Evidera, Inc, United States

Senior Director, Implementation Science Pillar Lead

Janine  Collins, MD, LLM

Speaker

Janine Collins, MD, LLM

United BioSource Corporation, Switzerland

Executive Director Safety, Epidemiology , Registries and Risk Management

Gita  Toyserkani, PharmD, MBA

Logic Model: A Tool to Bridge REMS Design and Evaluation

Gita Toyserkani, PharmD, MBA

FDA, United States

Associate Director, Research & Strategic Initiatives

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