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About ENCePP

Find out more about the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

 

Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Find out more

Do you wish to register a study in the EU PAS Register?

Find out more

Are you considering applying for an ENCePP study seal?

Read a personal account of the ENCePP study approval process

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

 

 

 

Latest News
10 December 2020

New ENCePP Steering Group, 2021-2023

 

The composition of the new ENCePP Steering Group for 2021-2023 has been published on the ENCePP Steering Group page. The ENCePP SG includes representatives from ENCePP partners, the EMA, EMA Scientific Committees and learned societies (International Society of Pharmacovigilance (ISoP), International Society for Pharmacoepidemiology (ISPE), International Society for Pharmacoeconomics and Outcomes Research (ISPOR)), and observers from the Food and Drug Administration (FDA), Health Canada and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The co-chairs of the Steering Group will be announced after the first SG meeting in January 2021.

 

Related information: Composition of new ENCePP Steering Group

 

10 December 2020

Report of the “ENCePP in the Time of Covid” meeting published

 

The report and the presentations of the virtual ENCePP webinar held on 20 November 2020 have been published on the ENCePP website. The meeting outputs will feed into the revision of the ENCePP mandate, which will aim to address the need for high-quality evidence supporting Covid-19 related regulatory decisions and to successfully integrate the network into the new research environment that will prevail from 2021, including DARWIN EU and other European efforts around AI and digital data capture. 

Related information: Meeting report and presentations

5 November 2020

ENCePP in the Time of Covid” virtual webinar for ENCePP Partners, 20 November 2020

 

The ENCePP webinar will discuss new challenges to be addressed by the ENCePP network and establish the new ENCePP Steering Group.

 

Objectives of the meeting:

  • To discuss methodological considerations for observational studies on Covid-19 and how ENCePP could promote best practice, especially for the monitoring of Covid-19 vaccines safety and effectiveness.

  • To present the recommendations of the HMA-EMA Big Data Task Force and the proposed Data Analysis and Real-World Interrogation Network in the European Union (DARWIN EU), and discuss the interface between ENCePP and the Task Force.

  • To summarise the achievements of the current ENCePP Steering Group, introduce the members of the new ENCePP SG and discuss proposals for a draft ENCePP mandate.

The webinar is open only to ENCePP Partners (centres and networks), who have expressed their interest via the registration form by 11 November (extended deadline).

 

Related information: Agenda

 

8 September 2020

Virtual workshop on the draft guideline on registry-based studies

 

A workshop on the draft guideline on registry-based studies scheduled for Monday, 19 October 2020 from 12:30-17:00 (CET) has been announced on the EMA website.

 

This half-day virtual workshop will give an overview of the Guideline that will be published for consultation at the end of September 2020, and will provide the opportunity for stakeholders to ask questions for clarification.

The meeting will be broadcast live on EMA’s website. In addition, there will be a limited capacity to participate in the virtual room for people who wish to make verbal contributions to the meeting. Interest in joining the virtual room can be expressed by completing the online form by 9 October 2020. After this deadline, the EMA will review the requests received and will select the participants to ensure a fair representation of the different stakeholders.

 

Related information:

» Workshop agenda

» Expression of interest form

 

Contact point: EMAregistries@ema.europa.eu

 

 

 

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