Developing Safety Analysis Plans for Regulatory Purposes
*George Rochester, U.S. Food and Drug Administration 

Keywords: PSaP, PRIM

In the current climate of heightened expectations from consumers, legislative bodies and other stakeholders, there is need to improve pre- and post-marketing safety evaluation. Product manufacturers and regulatory agencies are making extensive efforts to improve risk assessment in support of risk management activities to protect and promote public health. Safety evaluation must be systematically designed throughout the life-cycle of a product. This presentation will discuss three key concepts: (1) The Pre-approval Risk Identification Model (PRIM) which as model for identification of key safety concerns in the pre-approval period; (2) The Program Safety Analysis Plan (PSaP) as a tool for documenting the data collection and analytical framework in preparation for a dossier for product licensure; and (3) Communicating with regulatory bodies during the pre-approval period and beyond.