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EMA - GVP Guidelines for Consultation

5th February 2021

·         Guideline on good pharmacovigilance practices (GVP) - Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)

Revision 3 includes, among other updates, the clarification of the role of risk minimisation for risk management planning and for the impact on the risk-benefit balance of medicinal products, and the role of effectiveness evaluation of risk minimisation measures, and to delete/merge. It also gives more guidance about the criteria for applying/requesting additional risk minimisation measures; to give more details on the role of healthcare professionals and patients and to clarify possible strategies for their early engagement and role in risk minimisation development, dissemination and evaluation.

·         Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum II – Methods for effectiveness evaluation

This Addendum to GVP Module XVI provides additional guidance for marketing authorisation holders and competent authorities on data sources and methodologies for monitoring outcomes of risk minimisation measures (RMM) in line with the principles for RMM effectiveness evaluation laid down in GVP Module XVI. Depending on the risk minimisation objective, studies evaluating RMM effectiveness may integrate different quantitative measurements and qualitative research approaches to evaluate risk minimisation outcomes for individual tools or sets of RMM described in GVP Module XVI.

Comments should be provided using this template and sent to gvp@ema.europa.eu by 28 April 2021.

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