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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)?

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

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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
4 June 2021

Call for tender to establish the Coordination Center of the DARWIN EU launched

 

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published a procurement procedure today for setting up a framework to support better decision-making throughout the lifecycle of medicinal products with timely, valid and reliable evidence from real world healthcare data sources on the use, safety and effectiveness of human medicines, including vaccines.

 

This initiative, named Data Analysis and Real World Interrogation Network (DARWIN EU), will deliver a set of services that will include the establishment and operation of the DARWIN EU Coordination Centre, the onboarding of data partners, the establishment of connectivity to the European Health Data Space (EHDS), the maintenance of a continually enlarging catalogue of accessible observational data sources suitable for use in the regulatory context and the execution of  all steps of high-quality non-interventional studies to address regulatory questions (from development of scientific protocols, interrogation of relevant databases, data analysis and interpretation and reporting of study results).

 

The HMA/EMA Big Data Task Force recommended developing DARWIN EU in its final report of January 2020, and the creation of DARWIN EU is included in the EMA-HMA Big Data Steering Group workplan and the EMA Network Strategy to 2025.

 

The purpose of this tender is to select the contractor that will establish the Coordination Centre and that will deliver and operate  the set of technological and methodological services under the instruction and supervision of EMA for the provision of access to healthcare data and the execution of scientific studies to support decision-making of the EU regulatory Network.

 

The deadline for submission of requests to participate is 5 July 2021.

 

Related information: Procurement at EMA

 

29 April 2021

International collaboration to study the impact of Covid-19 and medicines on pregnancy, maternal and neonatal outcomes

 

The European Medicines Agency has contracted Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’) to collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccination policies and treatment options for COVID-19 in pregnant women.

CONSIGN is analysing existing data sources (e.g. electronic health records, hospital data) and cohorts of pregnant women to provide information on the effect of infection and its treatments in different trimesters of pregnancy and on neonates. The project is being carried out in collaboration with the ConcePTION consortium, which was established under the EU’s Innovative Medicines Initiative, the COVI-PREG project and the International Network of Obstetric Survey Systems (INOSS) network.

In its CONSIGN-International document, the Consortium describes ongoing initiatives and opportunities for international collaboration in the area of medicines use and their effects on management of COVID-19 in pregnancy. Such collaboration is open to any researchers who wish to participate. For further information, please contact Prof. Miriam Sturkenboom.

 

The ultimate goal of this work is to create a global and sustainable infrastructure for prospective benefit-risk monitoring of treatments in pregnancy beyond those used in COVID.

 

Related information:

 

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:

 

 

 

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