End of year closure

The ENCePP Secretariat will remain closed from 24 December 2014 to 4 January 2015 inclusive.

ENCePP plenary meeting - 25 November 2014

The 13th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 25 November 2014.

Participation is open to representatives from research centres and networks that have joined ENCePP.

Related information:

» Draft agenda, ENCePP plenary meeting 25/11/2014

» ENCePP plenary rules of procedure and mandate

» ENCePP Plenary meeting reports

Survey of methodologies for EU publicly funded multi-database safety studies

A report on the outcome of a survey of researchers coordinating multi-database drug-safety projects that have been publicly funded by the European Commission is now available. The survey was launched in August 2012 with the aim to define current practice in Europe in combining data from multiple sources.

Related information:

» ENCePP outputs

New PROTECT benefit-risk website

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) contains a number of work programmes whose goal is to strengthen the benefit-risk monitoring of medicines in Europe. Work program 5 (Benefit-Risk group) of PROTECT has developed a new website on available methods for benefit-risk evaluation and representation. It includes supporting tools and recommendations for use of benefit-risk methodologies and intends to be a guide for readers who are new to the world of benefit-risk assessment.

Related information:

» PROTECT benefit-risk website

» PROTECT project

Third revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The Guide is updated annually and revision 3 is now available on the ENCePP website. In addition to the revision or update of most chapters, it includes a new chapter on 'Design and analysis of pharmacogenetic studies', written in collaboration with the Special Interest Group in Molecular Epidemiology, Biomarkers and Pharmacogenetics of the International Society of Pharmacoepidemiology (ISPE).

Related information:

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The European Medicines Agency (EMA) is moving

The EMA is moving to a new office in Canary Wharf/London. The move will be gradually taking place during the month of July 2014, with different EMA departments moving on different dates until the move is completed at the end of July. From 1 August 2014 the EMA will begin operating from its new premises.

Related information:

» EMA office move

» Contact Us

Publication of the Clinical Trials Regulation

The Clinical Trials Regulation was published on 27 May 2014 in the Official Journal of the European Union (EU). The new legislation will not come into force until the necessary IT platforms to support the exchange of information are in place (see Articles 80 and 81). This is anticipated as being no earlier than mid-2016.

Related information:

» Official Journal of the European Union, L158/27 May 2014

» European Medicines Agency welcomes publication of the Clinical Trials Regulation

ENCePP Code of Conduct - Revision 3

On 21 February 2014 the ENCePP Steering Group adopted the 3^rd revision of the ENCePP Code of Conduct. This editorial revision of the Code was aimed at improving the overall readability of the Code and to provide further clarifications on the key concept of scientific independence in a new chapter and on the conditions for the ENCePP Study Seal, taking into account feedback from the ENCePP network and the practical experience from stakeholders. The key concepts of the Code remain unchanged.

Related information:

» Summary of the main changes introduced with the third revision of the Code

» ENCePP Code of Conduct

ENCePP Activities 2013

The ENCePP Secretariat has published a summary of ENCePP activities in 2013. In addition to the key milestones achieved during 2013, the document also includes some key metrics relating to research capacity building, as identified in the network's strategy for the impact evaluation of ENCePP, as well as some ENCePP website statistics.

Related information:

» ENCePP activity report 2013

Declaration of Helsinki and ENCePP

The most recent version of the Declaration of Helsinki was adopted by the 64^th World Medical Association (WMA) General Assembly in October 2013. Of particular note for ENCePP are the obligations relating to research registration and publication of results (Articles 35 and 36 of the Declaration). Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. The implications of the amendments for ENCePP outputs including the Register of Studies (EU PAS Register) and the Code of Conduct will be considered by the network in further detail in the coming months.

Related information:

» WMA Declaration of Helsinki (October 2013)

» ENCePP Code of Conduct