ENCePP Public Consultation

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ENCePP Guide on Methodological Standards in Pharmacoepidemiology

On 5 November 2010, the European Medicines Agency (EMA) released for public consultation a draft 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, 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.

The objective is to provide a structured architecture for thinking and learning through presenting:

• an overview of internationally acknowledged recommendations,

• key points from other existing English-language guidelines and standards in pharmacoepidemiology, and

• directions for learning on study design and methods.

The intention is not to duplicate the text from existing guidelines and textbooks, but rather to offer the researcher a single overview document and web resource that refers to specific existing guidances after a brief introduction or overview of the relevant guidance text.

The scope of the guide is to be dynamic. Systematic updates of this electronic document will, therefore, be performed each year. More frequent amendments may be performed for important modifications.

The document 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.

In acknowledgement of the diverse nature and levels of expertise among present researchers in Europe, ENCePP aims at encouraging participation across the spectrum of researchers and considers the current overview document appropriate to serve both experienced and relatively new researchers in pharmacoepidemiology.

ENCePP Code of Conduct for Independence and Transparency
& Checklist of Methodological Research Standards

On 16 November 2009, the European Medicines Agency released for public consultation a draft Code of Conduct for Independence and Transparency, and a draft Checklist of Methodological Research Standards that lay down key elements and principles for the conduct of “European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Studies”.

The objectives of the ENCePP Code of Conduct are to provide a set of rules and principles for Pharmacoepidemiology and Pharmacovigilance studies as regards:

• best practice in the relationship between investigators and study funders, including protocol agreement and publication of results, and
• transparency throughout the research process,
• thereby promoting scientific independence of such studies.

The objectives of the Checklist of Methodological Research Standards are:

• to stimulate researchers  to consider important epidemiological principles when designing a pharmacoepidemiological study and writing a study protocol;
• to promote transparency regarding methodologies and design used in pharmacoepidemiological studies performed in the EU;
• to increase awareness about developments in science and methodology in the field of pharmacoepidemiology.