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


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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Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR
Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers
New documents required by the medical device regulation
Risk management plans in the EU: Managing safety concerns
Scientific advice procedures in the EU – an overview ofthe regulatory background
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The new PubMed – underestimated regulatory obstacles
Ethical challenges in acknowledging professional writing support
Publication management software for medical writers
Regulatory Matters
News from the EMA
Medical Devices
Medical Communications and Writing for Patients
Getting Your Foot in the Door
Lingua Franca and Beyond
My First Medical Writing
In the Bookstores
Good Writing Practice

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