Medical Writing EU Regulations Risk management plans in the EU: Managing safety concerns

Volume 29, Issue 3 - EU Regulations

Risk management plans in the EU: Managing safety concerns

Abstract

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of submissions, definition of the safety concerns of a medicinal product, alignment with the key messages in marketing authorisation application dossiers, and interactions with health authorities during assessment. Safety concerns are a set of important risks and missing information that are defined during clinical development and carried forward into the post-marketing phase. The risk management plan (RMP) describes the system managing the safety concerns. Although safety concerns are well defined in the EU Good Pharmacovigilance Practice (GVP) guidance, in practice, they are nonetheless frequently the subject of interactions with health authorities. For the RMP, the revised definition of safety concerns in GVP Module V revision 2 has implications not only for other pharmacovigilance  documents, but also for the management of safety concerns worldwide.

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