United Kingdom-London: Effectiveness and pharmacoepidemiology studies EMA/2014/50/RE

'Post-authorisation effectiveness and pharmacoepidemiology research to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. EMA supports the conduct of this research in line with the principles and tools for scientific independence, transparency and sound methods of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The research may concern: research on the prescription and use of drugs and their resulting medical consequences (positive or negative) involving approaches such as observational research, qualitative research (including e.g. surveys or focus groups) and systematic reviews or meta-analyses of data from the literature and/or clinical trials, pharmacoepidemiological safety or effectiveness and pharmacoepidemiology studies that require data collection or use of electronic health care or other data where information on drug exposure and health outcomes can be appropriately linked for individual patients, quantitative and qualitative measures of effectiveness of regulatory actions including risk minimisation activities and the impact of legislation.'