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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
1 July 2021

9th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

 

The 9th annual Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published. The Guide is maintained by the ENCePP Research Standards and Guidance working group under EMA’s coordination. The 9th Revision has been extensively amended and re-organised with an improved structure. The foreword from the co-chairs of the ENCePP Steering Group highlights the importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns. Nearly all chapters contain relevant guidance on methodological standards to be used in COVID-19 studies, with references to selected publications illustrating relevant methodological aspects. This version will continue supporting sound pharmacoepidemiological research, including into COVID-19, and will provide a useful resource for clinicians, marketing authorisation holders and applicants, and regulators.

 

25 June 2021

Call for tenders for Real World Data Subscription published

 

The European Medicines Agency has published a new Call for tenders for Real World Data Subscription: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=8432.

 

The purpose of the Call is to get access to and use of a set of individual patient-level databases drawn from the population receiving primary care, specialist care and/or hospital care in EU/EEA countries. The call is split into 3 lots as follows:

 

•  Lot 1: Primary health care or claims database from a Southern European country (included countries: Cyprus, Greece, Italy, Malta, Portugal, Spain).

•  Lot 2: Primary health care or claims database from an Eastern European country (included countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia).

•  Lot 3: Hospital database from any EU/EEA country

 

Organisations may apply for one or several Lots and may submit joint offers. The deadline for applications is 30 July 2021.

 

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:

 

 

 

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