About
This course introduces the Risk Management Plan (RMP) and the related requirements, structure, content, and activities. Terms such as "safety concern" and "important risk" will be explained according to the GVP V Rev. 2 guidance and compared to definitions and use in other pharmacovigilance documents. In addition, the life cycle of RMPs and the interrelation between the RMP and the Periodic Safety Update Report (PSUR) will be addressed.