ENCePP releases for public consultation draft Guide on Methodological Standards in Pharmacoepidemiology
The European Medicines Agency (EMA) and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have released for public consultation a draft Guide on Methodological Standards in Pharmacoepidemiology.
The guide 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.
The guide has been developed over a period of several months by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research and has been peer reviewed and adopted by the ENCePP Steering Group.
Interested parties are asked to provide comments on the draft guide by January 3 2011. All further information including the PDF version of the guide and the feedback template are available from the ENCePP website.