Safety Surveillance Plans

Earlier this month at the DIA PV and Risk Management Meeting, it was exciting to see a session focused on Safety Surveillance Plans.

While most companies have had some type of SOP/plan/roadmap for safety surveillance, the FDA Guidance Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies issued in June 2021 put a name to it! JPCC has developed a very simple template that has helped our clients:

•  Document all ongoing safety activities/responsibilities – not just those in PV 

• Right-size their surveillance activities for a product based on the stage of development/level of activity

•  Document what is known about the product in one place prior to the need to develop a dRMP or RMP – anticipated events, dose-limiting toxicities, potential and/or identified risks, surveillance topics, etc.

Safety Surveillance Plans are great tools to facilitate cross-functional alignment on product safety.