EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI

On 3 February 2021 the EMA published the draft guideline on GVP Module XVI – Risk Minimization Measures: Selection of Tools and Effectiveness Indicators (Rev 3). Comments should be submitted by 28 April 2021.

Risk management includes the identification, characterization (including quantification), prevention and minimization of risks. Risk management systems consist of pharmacovigilance activities and interventions relating to individual medicinal products for this purpose, including the assessment of the effectiveness of those activities and interventions, in accordance with Article 1(28b) of Directive 2001/83/EC. The objectives of risk minimization are achieved through the implementation of risk minimization measures (RMM) required by the competent authorities and generation of evidence that these measures are effective.

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