-Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of one or more risks (called PASS "Post-Authorisation Safety Studies"), have been strengthened in the past years with the implementation of the concept of risk management plans (RMPs), established in 2005 in the European regulatory framework and recently amended as part of the community revision. These safety studies, interventional or not, are related to a marketed drug, whether or not the drug is used within the market authorisation conditions. Apart from these safety studies, other studies whose primary objective is not risk assessment, including assessment of efficacy, description of prescription data and use in real life, pharmacokinetics, public health impact . . . can complete available safety data.The Giens Round Table examined PASS from the risk management plans of a sample of marketing authorisation holders (participants to the Round Table) and identified the main characteristics of proposed actions. Concerning the specifications and the choice of methodology, only a general outline has been sketched in view of the complexity and diversity of drug risks situations.

Questions have been raised regarding the attractiveness of France versus other countries for performing clinical trials. A questionnaire was sent to pharmaceutical companies with offices in France to assess their level of activity and to get information on the pros and cons of performing phase I-IV international clinical trials in France. Eleven companies, of large to medium size and representing 44% of the shared market returned answers. In 2001, they spent 131 million euros on clinical trials -53% for phase I-III, with a staff of 1469 (not including Contact Research Organisations) -and involved 21 000 investigators recruiting 98 000 patients on local budgets, and 2257 investigators recruiting 10 270 patients on international budgets. France ranked well as regards size of market or resource availability, with an intermediate rank as regards costs, access to patients and disease prevalence, and was weak with regard to speed of recruitment and quality of investigators. Ways of improving France's attractiveness will be discussed.

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Résumé -La directive essais cliniques avait pour but une harmonisation des législations afin de favoriser la cohérence du système européen et par la même l'attractivité de l'Europe en matière de recherche clinique tout en maintenant ou renforçant la protection des personnes qui acceptent d'y participer. La situation française en matière administrative était jusqu'à présent relativement favorable (étude à notifier avec déjà un seul comité d'éthique par étude), il est donc important de maintenir la compétitivité sur ces points sachant que sur d'autres points (délais de mise en place des conventions, recrutement, ...) la situation n'est pas à l'avantage de la France. À l'heure actuelle, la transposition de cette directive n'est pas encore totalement finalisée en droit français. La période pilote qui a été mise en place par l'Afssaps (Agence française de sécurité sanitaire des produits de santé) a permis d'établir sans délais les modalités de mise en place. Pour les CPP (Comités de Protection des Personnes), la situation est plus critique dans la mesure où beaucoup de points restent à établir (choix des membres, règlement intérieur, rapport CA/CE [autorités compétentes/comités d'éthique]. . . ). L'atelier de Giens a permis de faire naître un certain nombre de propositions et souhaite par le biais du groupe de pilotage Afssaps / DGS (Direction Générale de la Santé) / LEEM (Les Entreprises du Médicament) continuer à contribuer à la mise en place d'un système efficace et protecteur pour les patients.

-The target population of a medicine may include different populations that may partially overlap including the population that has been evaluated in the clinical trials, the population for which the medicine provides an actual benefit (SMR), that for which the drug provides an improvement of the actual benefit (ASMR), etc. The definition of the target population in both qualitative and quantitative terms has key public health and economic implications. Recommendations are made to shed light on the definitions, to clarify the requests of the public decision makers and to improve the methods and the sources allowing the quantification of target populations.