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ENCePP News Archive

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:


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:

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

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:


10 July 2020

Eighth revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published


The 8th revision of the ENCePP Methods Guide has been published on the ENCePP website. This latest version includes revisions, amendments and new references in most of the chapters. Revisions were performed by the authors in collaboration with the editorial group. External comments received were also considered.

For this 8th revision, a foreword highlights the importance of the Guide for pharmacoepidemiological studies carried-out in the context of the COVID-19 pandemic in order to provide valid results useful for clinicians and regulators. The foreword guides the reader to the chapters that may be particularly relevant for such studies.

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology


27 May 2020

EMA calls for high-quality observational research in context of COVID-19


The EMA published a press release on 26 May 2020, calling for for high-quality observational research in the context of COVID-19. The text emphasises that when planning observational studies, researchers should adhere to existing guidelines on the appropriate design and conduct of pharmacoepidemiological studies in order to generate reliable and reproduceable evidence, including the ENCePP Guide on methodological standards in pharmacoepidemiology. EMA also reminds researchers to post all protocols and reports of observational COVID-19 studies in the EU PAS register to ensure transparency and scrutiny of study design and results. This text refers to the ENCePP COVID-19 Response Group promoting use and dissemination of valid and reliable methodologies appropriate to COVID-19.


25 May 2020

Mandate for ENCePP support to COVID-19 activities


On 18 May 2020, the ENCePP Steering Group endorsed a mandate for ENCePP activities in relation to the COVID-19 pandemic. It includes to facilitate access to high quality data and their analysis to support research and regulatory decisions in relation to the COVID-19 pandemic, to support collaborations aiming to design and conduct high quality multicentre observational research, and to improve regulatory science by promoting use and dissemination of valid and reliable methodologies appropriate to COVID-19.


Related information:

»  ENCePP COVID-19 Response Group mandate


12 May 2020

Discussion paper on the general data protection regulation: secondary use of data for medicines and public health purposes


The European Medicines Agency (EMA) is preparing guidance in the form of “Questions and Answers” on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines.
Therefore, EMA would like to gather input from patients, consumers and healthcare professionals as data contributors as well as from medicines developers, research-performing and research-supporting infrastructures and other data providers (e.g. payers of healthcare).
In the context of the General Data Protection Regulation (EU) 2016/679 (GDPR) and focusing on nine key topics outlined in the below discussion paper, EMA would appreciate to receive feedback on specific data protection questions on secondary data use.


The contributions can be sent by 10 July 2020 to the following functional mailbox:


Related information:

»  Discussion paper

»  EMA Big Data webpage (Section: data protection)


26 March 2020

Registration of COVID-19 related studies in the EU PAS Register


In these exceptional circumstances, many research groups in Europe and around the world have started or are planning observational studies related to the utilisation and effects of drugs in relation to the Covid-19 pandemic.


In order to support the sharing of information on performed or planned studies and increase the efficiency of research, ENCePP and EMA strongly encourage all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register.


Researchers are also encouraged to upload and make public the study protocol with a description of the data collected or planned to be collected in order to facilitate and speed-up the design of observational studies by others.


In order to facilitate the retrieval of studies related to the Covid-19 pandemic, investigators should  include the term “COVID-19” in the study title. Using this term in the field “Title of Study” of the search function will allow retrieval of all registered studies related to the pandemic.


Attention is drawn to the following recommendation issued by the International Committee of Medical Journal Editors (ICMJE): In the event of a public health emergency (as defined by public health officials), information with immediate implications for public health should be disseminated without concern that this will preclude subsequent consideration for publication in a journal. We encourage editors to give priority to authors who have made crucial data publicly available (e.g., in a gene bank) without delay.


Related information:

»  EU PAS Register®


15 January 2020
EU PAS Register® technical upgrade with new functionalities

The European Union electronic Register of Post-Authorisation Studies (EU PAS Register®) is the publicly available register of non-interventional post-authorisation studies (PAS) maintained by the European Medicines Agency. With the latest technical upgrade important functionalities have been added to meet our stakeholders’ business demands and to further increase transparency on non-interventional research for medicines authorised in the European Union. The January 2020 upgrade includes a number of new functionalities based on the feed-back received from stakeholders:

With this upgrade further functionalities have been added to facilitate administrative tasks performed by the Agency.

The EU PAS Register continues to gain importance as is a unique source of information on the safety and effectiveness of authorised medicines. By the end of 2019 a total of 1,674 studies have been registered which represents an increase of about 20% over the previous year.


Related information:

»  EU PAS Register®




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