Regulatory Requirements for a COVID-19 Vaccine Risk Management Plan (RMP): A Medical Writing Perspective

11:55 AM - 12:20 PM

The RMP is a key document in an EU submission dossier, with the aim of documenting an MAHs current knowledge of the safety and efficacy of a medicinal product and providing key information on plans for studies and other activities to gain more knowledge about its safety and efficacy.

This presentation aims to describe current regulatory guidelines that govern RMPs (primarily focusing on the EU RMP), in addition to challenges in data collection and presentation, and how to manage the often frenetic EU RMP evaluation process.