Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

The European Medicines Agency (EMA) has the responsibility for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU) to ensure that their benefits outweigh their risks. While the roots of medicines' safety monitoring lie in the development of mechanisms for spontaneous reporting of suspected adverse reactions by health‐care professionals and patients, the importance of using the full spectrum of evidence including observational studies has long been acknowledged. The risk management system introduced in the EU in 2006 highlighted the need to build capacity and to facilitate the conduct of multicenter independent postauthorization studies to investigate important risks or missing information in European populations. In March 2006, the EMA contacted more than 90 academic centers in Europe identified through the International Society for Pharmacoepidemiology (ISPE) and national drug regulatory authorities to request information on their expertise and activities in pharmacoepidemiology and pharmacovigilance. Over the following 12 months, possible models for collaboration on independent observational studies were discussed with representatives of academic and other research centers, pharmaceutical industry, other existing clinical networks, EMA scientific