Drug Safety 2007; 30 (10): 919-990 0114-5916/07/0010-0919/$44.95/0
ABSTRACTS
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Poster Presentations P.097 Pharmacovigilance and Clinical Trials: Experience of a French Pharmacovigilance Department H. Brocvielle, L. Thomas, H. Le Louet Mondor Hospital AP-HP, Creteil, France The European Directive 2001/20/EC relating to clinical trials on medicinal products was aimed at simplifying and harmonising European clinical research. It was published on the 4th April 2001 and was transposed into French law on 9th August 2004 by means of a public health law. This transposition actually came into effect on 27th August 2006, i.e. 4 months after the publication of decree n°2006-477 of 26th April relating to biomedical researches. Then, new legal provisions for clinical trials came into force in France. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, regulatory authorities and ethics committees concerning pharmacovigilance in clinical trials. A partnership between the Public Assistance - Hospitals of Paris (AP-HP) and our pharmacovigilance department has begun in 2006. The AP-HP which is the biggest hospital network in Europe employs over 80,000 people. This establishment is a complex organization that is responsible for a high standard of care, medical technology and research. It represents the largest clinical trial site in Europe. Its activity of biomedical and clinical research is driven by the Department of Clinical Research and Development (DRCD). Our pharmacovigilance department is located on Mondor hospital (one of the AP-HP hospitals). His personal is accredited by the European Medicines Agency for the electronic reporting of Individual Case Safety Reports (ICSRs) related to all medicinal products authorised in the European Economic Area. As an academic sponsor of clinical trials with responsibilities to report suspected serious unexpected adverse reactions, AP-HP has developed a partnership with our department. It means combining knowledge and also tools in order to comply with the regulations: • MedDRA dictionary • software tool for management and declaration of ICSRs (ES1-SafetyManager®) • software tool for secure exchange of data on Internet (NetIXServer®). One of the of AP-HP specificity is the protocol risk assessment according four levels which drives the intensity of monitoring required for a protocol and the establishment of an independent safety committee. Then, more than 700 reports of adverse reactions arising from clinical trials conducted by AP-HP on medicinal products for human use has been treated in 2006. About 100 reports were sent to competent authorities. Finally, this partnership between an academic sponsor of clinical trials and a pharmacovigilance department allows a continuum of pre- and postmarketing surveillance and assessment of drug safety. Furthermore, it leads to a real drug risk management and not simply to a signal detection.
