The roles and responsibilities of the EU qualified person for pharmacovigilance under Volume IXa March 2007

Graeme Ladds

DOI:https://doi.org/10.5912/jcb211

Abstract:

The role of drug safety both in drug development and post-marketing surveillance has increased enormously over recent years. For the EU, this has culminated in a designated individual, the qualified person for pharmacovigilance (PV), who has responsibility for the overall procedures that exist in a company for safety management. This role has evolved since it was first introduced in the late 1990s to a critical role in the company both in terms of managing risks with products while either still in the clinical phase or the post-marketing phase. Such a role demands that the person who takes on the mantle has to be knowledgeable in PV legislation. The new Eudralex Volume IXa issued in both January and then revised in March 2007 has again emphasised and clarified this role. All licence holders in the EU must have this person in place, and the scope of this role is discussed below.

Keywords:pharmacovigilance ,regulation ,inspection ,Volume IXa ,PSURs ,risk management plan ,quality management system ,en ,