DDA26 – Post-submission Pharmacovigilance Writing: Interactions with Authorities and Impact on RMPs and PSURs

Description

This workshop will explore medical writing tasks from first submission onwards and throughout the lifecycle of the medicinal product. Participants will learn how to handle authority requests and parallel RMP and PSUR preparation.

Participant profile: Medical writers who would like to gain advanced knowledge about RMP and PSUR assessment processes and the role of the medical writer after document submission in Europe. Participants without hands-on experience with RMPs and PSURs should in advance attend the courses DDA14a, DDF30, or DDF32.