End of year closure

The ENCePP Secretariat will remain closed from 22 December 2017 to 2 January 2018 inclusive.

Efficacy and safety studies on medicines (open tender ref. EMA/2017/09/PE)

The European Medicines Agency has launched an open call for tender with the aim of establishing a number of framework contracts with research organisations for efficacy and safety studies on medicines to generate data and information to support regulatory decision-making, as and when required, for a period of four years. The specific studies may concern research under four different lots.

Related information:

» Call for tenders: ref. EMA/2017/09/PE

2017 ENCePP plenary meeting

The meeting report and presentations from this year's ENCePP plenary meeting have been published and may be consulted in the documents section of the ENCePP website.

Related information:

» Plenary meeting reports

EU PAS Register

The EU PAS Register will be affected by essential maintenance activities from Wednesday 29 November (18:00 UK time) through Friday 1 December. Service is expected to resume during Friday. During this period the EU PAS Register services will be limited. Certain study fields cannot be modified (Country, Substance, ATC Code and medical condition related information of a study). Users may continue to consult studies.

Related information:

» EU PAS Register

ENCePP plenary meeting 2017

The 16th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 21 November 2017.

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

Related information:

» Draft Agenda - 16th ENCePP Plenary meeting

» ENCePP Plenary meeting reports

EU PAS Register

The EU PAS Register will be affected by essential maintenance activities scheduled to start at 18:00 (UK time) on Thursday 12 October which are expected to be concluded by 24:00 (UK time) on Friday 13 October.  During this period the EU PAS Register services will be limited. Certain study fields cannot be modified (Country, Substance, ATC Code and medical condition related information of a study). Users may continue to consult studies.

Related information:

» EU PAS Register

International Society of Pharmacovigilance (ISoP) Annual Meeting

The International Society of Pharmacovigilance (ISoP) annual meeting is taking place in Liverpool during October (16th-18th). In addition, there are two pre-conference workshops on 15th October. The conference programme will link traditional pharmacovigilance with innovate approaches from other sectors, including how novel analytical platforms provide both opportunities and challenges. For more information, including the programme, pre-conference workshops and registration, visit http://isop2017liverpool.org/

ENCePP: 10 years of collaboration to strengthen the monitoring of benefits and risks of medicines in Europe

A new infosheet on ENCePP has been published to coincide with the 10 year anniversary of the network.

Related information:

» ENCePP Infosheet

» ENCePP: 10 years for excellence in medicines safety

EU PAS Register®

The European Union Intellectual Property Office (EUIPO) has approved the registration of ‘EU PAS Register’ as a European Union trade mark.

Related information:

» Platform for post-authorisation studies registered as EU trade mark

» EU PAS Register

Sixth revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website. This latest version includes revisions, amendments and new references in all the chapters. Important changes were made to a number of chapters to take account of developments in some areas or the need for restructuring and clarification. Three new chapters have been added: Introduction, Patient registries, and Surveys.

Related information:

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

ENCePP Work Plan 2017-2019

The ENCePP Steering Group has adopted the network's new three year work plan. The main goal during 2017 to 2019 will be to optimise ENCePP's input to regulatory decision-making throughout the product life-cycle. Particular focus will be on the development of methods in impact research and to identify enablers and barriers to measuring the impact of pharmacovigilance.

Related information:

» ENCePP Work Plans

EU PAS Register

The European Union (EU) electronic Register of Post-Authorisation Studies (EU PAS Register) has reached a major milestone with 1000 registered studies in February 2017.

Related information:

» Over 1,000 studies now recorded in EU register of post-authorisation studies

» EU PAS Register

ENCePP activity report 2016

The ENCePP Secretariat has published a summary of the network's activities in 2016. The report provides a list of key achievements, a number of metrics relating to the network's expertise and experience, plus some website statistics.

Related information:

» ENCePP activity report 2016