By Janine Collins, MBBS, LLM, UBC and Dafna Bonneh-Barkay, PhD, MSc, UBC
On Friday, 31 March 2017 the EMA released the revised Module V- Risk Management Systems (Rev 2) of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2) accompanied by a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev.2).
Rev 2 of Module V and the template provide welcome changes to the RMP by focussing on the RMP as being a dynamic, scientifically based, risk- proportionate document where much of the previous cumbersome duplication across modules has been removed. However, converting an RMP from the Rev 1 format to Rev 2 will not be a simple matter of condensing and copy/pasting. The content requires scientific rationale and justification throughout with a critical need for in-depth understanding of the safety profile of the product. This article is an overview of the major changes in Rev 2.