Safety Reports: The importance of high quality content from regulatory perspective

The action plan developed by the AEMPS and published April 2016 focuses on the set up of specific activities, such as the publication of Risk Management Plans Summaries by the agency or the need to increase the number of inspections included in the Good Pharmacovigilance Practice programmes for human and veterinary use. Essentially, this infers…

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…