Position Offer: Post-doc in Pharmacoepidemiology (12 month duration) Project DRUGS-REWIND DRUGS-REgulation: Withdrawal Impact aNd Determinants - DRUGS-REWIND Starting date: as soon as possible Post-doctoral residency supervisor Antoine Pariente, Inserm U657 “Pharmacoepidemiology and Population Impact of Drugs” antoine.pariente@u-bordeaux.fr tel: +33 (0)5 57 57 15 60 / +33 (0)5 57 57 95 11 Missions and Objectives of the Post-Doctoral residency in Pharmacoepidemiology The residency objective, within the DRUGS-REWIND project, is the contribution to study design and the conduct of the statistical analyses allowing assessing the population health impact of regulatory actions identified a priori using electronic healthcare databases. The elaboration of the list of regulatory actions that will be evaluated is still ongoing. It will mostly include withdrawal decisions and actions, but can also integrate other types of actions. Required competencies and expertise We are looking for a junior researcher who would have, developed and demonstrated skills in pharmacoepidemiology and pharmacoepidemiologic analyses of electronic healthcare databases during her/his PhD. The applicant will necessarily have demonstrated her/his ability for scientific writing. Knowledge and experience in the use of the French Health Insurance Databases will constitute an advantage. Applicants without such expertise will have the opportunity to acquire it during their residency if they were selected. Applicants will need to be trained in the use of SAS software and in the use of time-series techniques. DRUGS-REWIND scientific context and objective Scientific context Regulation actions concerning drugs are undertaken with the aim of improving population health while containing, as much as possible, costs for communities. Two broad types of actions can be distinguished: those leading to market access or enlargement, and those leading to market shrinkage or withdrawal. Actions related to market enlargement/access are usually motivated by the potential benefit associated with drug efficacy, whereas those related to market shrinkage are motivated by safety concerns. The public health impact of these regulatory actions has rarely been investigated. 1 As the drug market is the product of political and societal construct, determinants of regulatory actions exceed by far the sole information brought by Evidence-Based Medicine which, despite being supposed to provide scientific background for these decisions, can be of marginal importance in these decisions. The influence of the drug environment and different health stakeholders in the discussions leading to drug regulatory actions, the functioning of drug regulatory agencies, and the final content of regulatory actions concerning drugs will be studied. Concomitantly, for regulatory actions that have been implemented in recent years, an assessment of population health impact will be performed, in addition to the usual study of changes to drug/healthcare patterns of use. Objectives (1) To understand the emergence of public health questions related to drugs as society concerns (2) To study the governance of drug regulatory agencies, their functioning, and the process leading to the structuration of the regulatory decisions or recommendations for drug use. (3) To study the impact of regulatory decisions on drug use and population health. DRUGS-REWIND Academic context: The Université de Bordeaux HEADS initiative (Health Determinants in Societies) The Université de Bordeaux launched this initiative in 2014. Its objective is to promote transdisciplinary research in healthcare; it consists of supporting the planning of seminars, learning programmes, and research projects, some of which it can fund. The DRUGS-Rewind project is one of four research projects that were selected to benefit from the Université de Bordeaux HEADS initiative. A trandisciplinary approach is essential to investigate adequately the research questions related to DRUGS-REWIND objectives. Consequently, the whole research project will be conducted in collaboration by researchers in pharmacoepidemiology, political sciences, and economy. Two post-doc positions are proposed (one in Pharmacoepidemiology, one in Political sciences and economy) for a duration of eighteen months each. In addition to her/his specific research objectives, each post-doc researcher will be given the opportunity to contribute to the joined achievements planned in the project. 2