The NCTO PvWG consists of Pharmacovigilance representatives from each of the HRB-Clinical Research Facilities/Centres. It is co-chaired by Prof. Pat Murray Clinical Director, UCD Clinical Research Centre and Dr. Ruben E. Keane, NCTO QRM. NCTO PvWG aims to share best practice and experience, avoid duplication and maximise resources in this highly specialised area of Clinical Research. We discuss issues of common interest, the level of Pv Activity across the region, how to implement Pharmacovigilance under new legislation (Clinical Trials Regulation, Medical Device Regulation etc). The group produces an annual report (for HRB) on the level of Pv Activity across the HRB-CRF/Cs.