Pharmacovigilance and Risk Management Strategies Conference

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.