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Session 13: REMS Case Study
Session Chair(s)
Carla Barrett, PHARMD
Vice President, Global Risk Management
Novavax, United States
- The REMS group will be asked to provide an overview of the fictional REMS, describe the product’s risks, discuss the objectives of the REMS, review the additional risk minimization activities selected, and present the plan for implementation and evaluation as if they were presenting to an internal Safety Management Team and/or the Food and Drug Administration (FDA) for approval.