The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network coordinated by the European Medicines Agency (EMA), playing a key role in developing the principles and best practices for the planning, design, conduct and reporting of post-authorisation safety studies (PASS). These are referenced in the good pharmacovigilance practices (GVP) guideline on PASS. Moreover, The ENCePP website hosts the European Union electronic register of post-authorisation studies (EU PAS Register), which contains public information on non-interventional post-authorisation studies (PAS). The register aims to increase transparency and reduce publication bias.
The EMA has announced that ENCePP will enter a next phase of its Business Continuity Plan (BCP) which will ensure the continuation of activities of the network. The BCP is explained by the anticipated loss of staff members from the Agency, although the Agency has intensified the preparations for the UK’s withdrawal from the EU and EMA’s relocation to Amsterdam. The objective is to allow the reallocation of available resources as needed to maintain the highest priority activities that are either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European regulatory system.
The EMA’s senior management has decided that a next phase of the BCP will come into effect on 1st October 2018 and that this phase will include suspension of a number of EMA activities, including all planned workshops and meetings, except those that are product-related. The EMA is also suspending all working groups that are not product-related as well as guideline development.
This decision has an impact on ENCePP related activities, and the ENCePP plenary meeting scheduled for 20 November 2018 and the face-to-face meeting of the Steering Group on 19th November 2018 will be cancelled.
Routine ENCePP activities not requiring EMA organisational meeting support or guidance work will not be affected. All product-related interactions with ENCePP partners will continue as and when requested by the Pharmacovigilance Risk Assessment Committee (PRAC).
The ENCePP Secretariat will explore which alternative measures might be available that help avoid a disruption of the network.