We would like to inform you that the European Medicines Agency (EMA) has released for public consultation a draft European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) 'Guide on Methodological Standards in Pharmacoepidemiology'.

This guideline has been developed by ENCePP, a collaboration between the EMA and the pharmacoepidemiology research community that aims to strengthen the post-authorisation monitoring of medicines by facilitating the conduct of multi-centre, independent and scientifically robust studies focusing on safety and the balance of benefits and risks. In line with this objective, the Guide seeks to assure high quality pharmacoepidemiological 'ENCEPP studies' to fuel learned regulatory decision making and to stimulate innovation that benefits patients and public health at large.

We invite you to visit the ENCePP webpage at http://www.encepp.eu/public_consultation/index.html and to provide us with your comments. Please feel free to pass on this information to anyone interested in conducting pharmacoepidemiology and pharmacovigilance studies.

Comments may be provided until 3 January 2011 to the ENCePP Secretariat (encepp_secretariat@ema.europa.eu).

Kind regards,

Kevin Blake

Coordination and Networking Section
Pharmacovigilance & Risk Management
Patient Health Protection Unit

European Medicines Agency
7 Westferry Circus, Canary Wharf
London E14 4HB, UK

Tel (direct): +44 20 7418 8361
Alternative contact: +44 20 7523 7655, +44 20 7523 7280
Fax: +44 20 7418 8668
e-mail: encepp_secretariat@ema.europa.eu
Internet: www.encepp.eu and www.ema.europa.eu