News

The European Medicines Agency has published on its website a concise report of a survey targeted to academic stakeholders in the context of the definition of a framework of collaboration with academia.

A new version of the EU PAS Register was released on 14 July 2016. This latest upgrade includes a number of performance enhancements and important improvements in terms of searching and data management.

The Checklist has been revised and now includes reference to sections, rather than page numbers of protocols.

The Guide is updated annually and revision 5 – with updates, amendments or clarifications of most chapters - is now available on the ENCePP website.

Since 2009, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) has generated a significant amount of scientific research in pharmacovigilance, pharmacoepidemiology and benefit-risk evaluation.

The ENCePP Working Group on Research Standards and Guidances has developed a short questionnaire with a view to enhancing the ENCePP Guide on Methodological Standards in Pharmacoepidemiology.

Abstracts for the 32nd International Conference on Pharmacoepidemiology and Therapeutic Risk Management (2016 ICPE) are now being accepted online!

Annex 1 to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology is now available. This methodological guidance addresses the conduct of systematic reviews and meta-analyses of drug safety endpoints generated in completed (published or unpublished) comparative pharmacoepidemiological

The CIOMS Working Group on the Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects has completed a draft revision of these updated guidelines and has published them on the website of CIOMS for consultation.

The Accelerated Development of VAccine benefit-risk Collaboration in Europe
(ADVANCE) is a a public-private partnership supported by the Innovative Medicines Initiative in order to establish a scientific and transparent framework for the rapid monito

The Guide is updated annually and revision 4 - with a revision or update of most chapters - is now available on the ENCePP website

This information day will take place on 5 June 2015 at the EMA premises in London. It will provide an overview of regulatory procedures, requirements and scientific guidelines on the conduct of both safety and efficacy studies.

The ENCePP Steering Group has adopted the network's work plan for 2015 and 2016.
The focus of ENCePP during 2015 and 2016 will be on extending the scope of the network to support regulatory decision-making across the product life cycle.

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

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 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.

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

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.

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).