ICPE 2016

Call for Abstracts - Deadline: February 17, 2016

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

The 2016 ICPE is a unique forum for the exchange of scientific information from the fields of pharmacoepidemiology and therapeutic risk management among those in the pharmaceutical industry, government, academia, service providers, regulators, consulting firms, health insurers, and contract research organizations. The meeting is acknowledged widely as the preeminent global conference on pharmacoepidemiology and therapeutic risk management.

Related information:

» ISPE website

Guidance on conducting systematic reviews and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes

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the conduct of systematic reviews and meta-analyses of drug safety endpoints generated in completed (published or unpublished) comparative pharmacoepidemiological studies.

Related information:

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

End of year closure

The ENCePP Secretariat will remain closed from 23 December 2015 to 3 January 2016 inclusive.

ENCePP plenary meeting - 24 November 2015

The 14th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 24 November 2015.

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

Related information:

» Draft agenda - 14th ENCePP plenary meeting

» ENCePP Plenary meeting reports

Public consultation: CIOMS Ethical Guidelines for Biomedical Research Involving Human Subjects

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 consultation will be open for comments until 1 March 2016.

Related information:

» Further information from CIOMS

» CIOMS Guidelines - Public Consultation

ADVANCE Code of Conduct for public 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 monitoring of the benefits and risks of marketed vaccines. For this purpose, ADVANCE is developing a Good practice guidance with a Code of Conduct for the planning, initiation, design, conduct and reporting of observational studies in the field of vaccines. The Code of Conduct will also support interactions between different parties involved in studies on vaccines and provide confidence to health professionals and the public about the quality of their results.

ADVANCE has launched a public consultation of the draft Code of Conduct until 15^th November 2015.

Related information:

» ADVANCE website

FAQ - EU PAS Register

The ENCePP Secretariat has published a list of frequently asked questions relating to the EU PAS Register.

Related information:

» EU PAS Register

Fourth revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

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

Related information:

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

Joint Drug Information Association (DIA)/European Medicines Agency (EMA) Information Day on Post-Authorisation Studies (PAS)

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, and explore the benefits of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) in supporting stakeholders in the conduct of PAS for regulatory decision making.

Related information:

» Joint DIA/EMA Information Day on PAS

ENCePP Work Plan 2015-2016

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. This will take ENCePP to the next level as a key provider for data and information for regulatory and healthcare decision-making and patients.

Related information:

» ENCePP Work Plan 2015-2016

ENCePP activity report 2014

The ENCePP Secretariat has published a summary of ENCePP activities in 2014. The report includes a list of key achievements and also provides some metrics relating to the network's growth and strengthening, as well as some ENCePP website statistics.

Related information:

» ENCePP activity report 2014