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…

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…