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

Drug Development
Workshop 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.
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.
RMPs are prepared for new marketing applications. Within the authorisation procedure and also later on, throughout the lifecycle of the medicinal product, the RMP may have to be updated to always reflect the most current knowledge on the product’s risk profile. After marketing authorisation, PSURs will be prepared. The assessment of PSUR and RMP may often impact both documents and requests may have to be addressed at the same time and within short timelines. The medical writer provides guidance to the product teams and plays a central role throughout the submission and assessment procedures of RMPs and PSURs. The workshop will cover a variety of pharmacovigilance writing activities between RMP submission and closing sequence (e.g., responses to authority questions, RMP updates),will explore PSUR evaluation procedures, and the impact of PSUR assessment on the RMP (e.g., addressing assessment report requests in the next PSUR and/or RMP). We will guide participants through possible scenarios and address typical questions and pitfalls.