End of year closure

The ENCePP Secretariat will remain closed from 23 December 2021 to 3 January 2022 inclusive.

ENCePP Plenary webinar registration is open to ENCePP Partners

The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021.

Registration is open to ENCePP Partners (centres and networks) until 26 October 2021.

Objectives of the meeting:

• To learn about key results from observational studies on Covid-19, methodological challenges that remain to be addressed, and how ENCePP could further promote best practice for Covid-19 research;

• To present the recently finalised CHMP Guideline on registry-based studies;

• To update on the work programme of the HMA-EMA Big Data Task Force and discuss the interface with ENCePP activities. Topics for discussion include the creation of curricula in Data Science, Pharmacoepidemiology and Biostatistics, the upgrading of the EU PAS Register and ENCePP Resources Database, an update on the Real-World Interrogation Network in the European Union (DARWIN EU) and the pilots for data analytics with EMA committees;

• To discuss the result of the surveys and agree on the amendments needed for the metadata and functionalities of the EU PAS Register and ENCePP Resources Database;

• To exchange views on the activities of the ENCePP Steering Group and Working Groups (WGs), the renewal of the WGs, and the proposed new ENCePP activities (e.g. new SIGs).

The event is for ENCePP Partners only, registration from other individuals will not be accepted.

The WebEx joining instructions will be sent to those ENCePP members who have registered via the below linked form.

Related information: Draft agenda | Registration form

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

The 9^th 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 9^th 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.

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.

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

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:

• CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study
• Registry for pregnant women exposed to SARS-CoV-2 (COVID-19, CONSIGN study)
• COVID-19 infections and medicines in pregnancy- the INOSS collaboration

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

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

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:

• ACCESS template protocols for effectiveness of COVID-19 vaccines
• ACCESS template protocol for safety of COVID-19 vaccines

• Coverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project