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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

 

 

 

News
8 April 2021

SNE positions on the EMA website

 

The European Medicines Agency has published three Seconded National Expert (SNE) positions in the following areas on the EMA website:

- EudraVigilance/Pharmacovigilance

- Biostatistics/Epidemiology

- Data Sciences

 

Deadline for applications: 28 April 2021

 

Related information: EMA career page

3 March 2021

ENCePP webinar for Academia - Real world research on medicines

 

EMA is holding an ENCePP webinar on 8 March from 10.00 to 12.00 for Academia communities / Learned societies to gain a better understanding of what ENCePP is and how it contributes to improving pharmaco-epidemiological research especially in circumstances such as a pandemic. ENCePP members will share their experience in working with the ENCePP tools and will illustrate how the network supports Academia’s observational research. In addition, they will discuss important methodological aspects of providing high-quality evidence from observational studies to support regulatory and public health decision-making, as well as the related challenges. The event will be broadcast.

 

Related information: EMA event page with agenda and presentations

 

25 February 2021

Background rates of AESIs for COVID-19 vaccine safety monitoring published

 

A series of Excel files with background incidence rates for 26 adverse events of special interests (AESIs) for COVID-19 vaccine safety monitoring have now been published on the ENCePP website. These background rate data are part of the work done by the EMA-funded ACCESS (vACcine Covid-19 monitoring ReadinESS) project led by the University Medical Center Utrecht and Utrecht University. They have been generated  from 7 data sources in 5 countries (United Kingdom, Spain, Italy, Denmark, Germany). Data from the Netherlands and France and additional data from Spain should be available in March.

 

ACCESS had already published in the EU PAS Register protocol templates for assessment of the effectiveness, safety and coverage of COVID-19 vaccines, with three entries:

 

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

 

 

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