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Pharmacovigilance and Risk Management Strategies Conference


Session 12: The Lifecycle of a REMS

Session Chair(s)

Jill K. Logan, PharmD

Jill K. Logan, PharmD

  • Safety Evaluator, DPV I
  • Office of Surveillance and Epidemiology (OSE), CDER, FDA, United States
Ingrid N. Chapman, PharmD

Ingrid N. Chapman, PharmD

  • Senior Risk Management Analyst, DRM, OMEPRM, OSE, CDER
  • FDA, United States
Risk evaluation and mitigation strategies (REMS) are drug safety programs required by FDA and developed by manufacturers to ensure the benefit of a drug or biologic product outweighs its risk. Risk management is an iterative process that includes assessing the drug’s benefit-risk balance, developing and implementing tools to minimize risks while preserving benefits, evaluating the effectiveness of the intervention(s) and adjusting, as appropriate. REMS are designed to mitigate a specific risk by reinforcing medication use behaviors and actions that support the safe use of the drug product. Following approval of a REMS, it is important to assess the effectiveness of the REMS and to consider if there are opportunities to improve the implementation of the REMS to reduce the burden to stakeholders. This session examines REMS development, implementation, assessments, and modifications which will be discussed and illustrated with examples.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Link interventions to measurable outcomes
  • Identify pathways to REMS modifications
  • Discuss how post-marketing data or assessments may impact the REMS and lead to modification

Speaker(s)

Shelly  Harris, DrSc, MPH

Speaker

Shelly Harris, DrSc, MPH

  • REMS Assessment Team Leader, OSE, CDER
  • FDA, United States
Catherine  Baldridge, MSc

Speaker

Catherine Baldridge, MSc

  • Founder/Owner, Principal Consultant
  • Essential Pharmacovigilance, LLC, United States
Elisa  Gomez-Reino, MPH

REMS Changes Over Time

Elisa Gomez-Reino, MPH

  • Senior Director, Regional Safety Excellence US and Canada
  • Alexion Pharmaceuticals, Inc., United States