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4th International Conference and Exhibition on Pharmacovigilance & Clinical Trials

London, UK

Angela vander Salm

Angela vander Salm

DADA Consultancy

Title: The EU-RMP - planning Risk Management in a feasible fashion


Biography: Angela vander Salm


Since 2012, every new marketing authorization within the European Union (EEA) requires the inclusion of a risk management plan. With the introduction of the good pharmacovigilance practices, the template of the RMP has undergone major modifications. The current template can be found by consulting GVP module V. Depending on the type of application, certain modules can be omitted or require less information. If the RMP includes the implementation of additional PV or risk minimization measures, an implementation plan is necessary in order to be able to assess the adequate roll-out of the proposed measures and to facilitate the required assessment of effectiveness of the included measures. In this workshop, we will touch upon writing and implementation of the EU-RMP, best practices and upcoming changes and improvements.

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