Data driven regulatory science

Abstract

Background: Drug regulatory science closely relates to pharmacoepidemiology, particularly where epidemiologic methods are used to derive empirical evidence on the outcomes and implications of drug regulation. Objectives: In this symposium, we will present the results from recent regulatory science studies on the functioning of post-marketing surveillance systems. Description: After a short introduction of the scientific field and methods applied to evaluate pharmacovigilance systems, results from four recently performed studies will be presented. The studies cover different aspects from the pharmacovigilance system in different continents: (1) Predictors of successful pharmacovigilance systems in Africa: determinants of ADR reporting in African countries (Hilda Ampadu) (2) FDAAA mandated 18 months, 10 000 patient reviews: experiences with the first cohort of newly approved products in the USA since 2007 (Shohko Sekine) (3) Characteristics and follow-up of post-marketing obligations of medicinal products with a conditional marketing authorization in Europe, 2006- 2014 (Jarno Hoekman) (4) The role of registries in European post-marketing surveillance, a retrospective analysis of centrally approved products, 2005-2013 (Xavier Kurz) A multidisciplinary panel will provide their views and results of the studies. Implications for policy and further research will be discussed with panelists and the broader audience. Three different angles of focus will be chosen. The academic perspective: What are the implications for data collection and methodologies? The regulatory perspective: What are the implications for design and enforcement of post-marketing obligations? The pharmacovigilance perspective: What are the implications for how to organize to post-marketing surveillance in practice?