RMP changes to GVP Module V- A doorway to better risk-oriented, scientifically valuable RMPs

On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2), together with a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev 2). During the transition period, RMPs prepared according…