Pharmacovigilance: EMA proposed changes to preparation of risk management plans.

In early 2016, the European Medicines Agency (EMA) started a major revision process of the good pharmacovigilance practice (GVP) Module V on risk management systems. Consequent to this, the Agency shared its intention to implement new modifications in the preparation of risk management plans (RMPs), in order to express the experience gained in the last few years. A public consultation was deemed…