EMA’s Pharmacovigilance Inspectors Working Group release 2017 work plan

The Pharmacovigilance Inspectors Working Group (PhV IWG), set up by the European Medicines Agency (EMA), aims to coordinate and harmonise pharmacovigilance related activities within the EU.

The PhV IWG has issued its work plan for this year which details the topics of focus.

One of the PhV IWG’s priorities is for 2017 is to implement (or continue to implement) the processes for sharing information and coordination of pharmacovigilance inspections between the agency, the Members States (inspectors and assessors) and the European Commission. The group aims to write or revise various guidance documents including, for human medicines, updating of GVP Module II on the pharmacovigilance system master file (PSMF) and GVP Module III on pharmacovigilance inspections. Another point of interest is the training and development of inspectors and Pharmacovigilance Risk Assessment Committee (PRAC) members those in the pharmacovigilance industry.

The PhV IWG will collaborate with the European Commission as well as liaise with other working groups and regulatory bodies within and outside of the EEA.   At an international, PhV IWG says it will seek strengthened contacts between EU and non-EU/EEA agencies on pharmacovigilance matters. The group will also continue to cooperate with the PIC/S, facilitating joint visits when possible.

For a more detailed insight as to what the PhV IWG have planned and what they hope to achieve, click here.