ENCePP Q&A

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network coordinated by the European Medicines Agency (EMA). Its members - the ENCePP Partners - are public institutions, networks, and contract research organisations (CROs) involved in pharmacoepidemiology and pharmacovigilance research. Research topics include the assessment of the benefits and risks of medicines, disease epidemiology, and drug utilisation. ENCePP Partners are registered in the HMA-EMA Catalogues under institutions or networks. Participation to ENCePP is voluntary. 

ENCePP originates from EMA’s endeavour to enhance scientific and operational expertise in the fields of pharmacoepidemiology and pharmacovigilance across Europe. ENCePP was launched in 2007 as a key initiative within the European Risk Management Strategy (ERMS) adopted by the Heads of Medicines Agencies (HMA) and has since become a large community bringing together expertise and resources for discussions on methods and conduct of non-interventional studies, based on principles of transparency, scientific independence, and common quality standards. In a fast-changing real-world evidence (RWE) landscape, ENCePP continues to develop and fulfil its mission through its workplan.

ENCePP aims to strengthen the monitoring of the benefit-risk profile of medicinal products in Europe by:

• Bringing together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe and providing a platform for collaborations;
• Facilitating the conduct of high quality, multi-centre, independent non-interventional studies NIS);
• Developing and maintaining methodological standards and governance principles for research in pharmacovigilance and pharmacoepidemiology;

Providing a network of excellence in pharmacoepidemiology that can be leveraged in public health emergencies.

ENCePP’s stakeholders include researchers, regulatory and public health authorities, patients and healthcare professional associations, contract research organisations, and the pharmaceutical industry. The ENCePP website describes the activities of the network and provides access to ENCePP tools, meeting documents, and reports.

ENCePP focuses on public and not-for-profit organisations located in one of the EU or EEA countries. These can be research centres, pharmacovigilance centres, university hospitals, and/or owners of healthcare data sources. Participation in ENCePP is also open to for-profit organisations such as contract research organisations (CROs), provided they perform studies commissioned by third parties and focussed on pharmacoepidemiology and pharmacovigilance research.

UK members who joined ENCePP before Brexit remained ENCePP Partners, but can no longer be members of the Steering Group. New applications from UK institutions and networks to join ENCePP are no longer accepted. 

Public bodies in the current EU candidate countries and potential candidates may apply to become ENCePP Partners, but cannot be members of the Steering Group.

Pharmaceutical companies cannot be ENCePP Partners but are encouraged to make use of the ENCePP resources and tools.

Being an ENCePP partner represents a commitment to:

• Actively contribute to the work of ENCePP and the rollout of the work plan. This includes but is not limited to participation in Working Groups and Special Interest Groups, attendance of Plenary meetings, response to public consultations as applicable, etc;
• Adhere to the principles of the ENCePP Code of Conduct;
• Apply good practices and methods as described in the ENCePP Guide on Methodological Standards in Pharmacoepidemiology;
• Register non-interventional studies in the HMA-EMA Catalogue of RWD studies,
• Collaborate with other ENCePP Partners, e.g., in multi-centres or multi-database studies, and share their research experience with the ENCePP community.

ENCePP Partners are institutions or networks, and are all registered in the EMA-HMA RWD Catalogues. Each registered institution or network has a main and an alternate contact. The ENCePP Secretariat uses their email contacts for the purpose of all communications (e.g., sharing news items, surveys, ENCePP Plenary invitations, ENCePP Steering Group election calls, etc.). 

There is no end date but ENCePP Partners are required to update their information in the Institutions or Networks of the RWD Catalogues at least every three years. If the information has not been updated, the partnership is revoked.

You can update the ENCePP status of your network/institution in the RWD Catalogues. When you submit your changes for publication, please add in the ‘Revision log’ that you have removed the ENCePP partnership status for your institution/network, with a short rationale if possible.

A few months before the meeting, the ENCePP Secretariat sends a call for interest to all ENCePP Partners contacts registered as Institutions/Networks in the RWD Catalogues. Any ENCePP Partner may express interest. Due to space and budget limitations for in-person attendance, EMA considers the balance of representatives by stakeholder group when reviewing the applications and finalising the list of attendees. Details on the process are always communicated in the call for interest email. 

UK/EU candidate country members of ENCePP may join the Plenary virtually (e.g., Webex).

There are several means by which you may contribute to the work of ENCePP:

• Express interest to join an ENCePP WG or SIG – see the Working Groups and Special Interest Groups page;
• Share suggestions during the ENCePP Plenary meetings;
• Contact the ENCePP Secretariat at any time with your suggestions, which will be communicated to the Steering Group as applicable.

The ENCePP Secretariat communications channels are the ENCePP website and the email distribution list. Responses to the communications and suggestions are welcome and appreciated.

ENCePP Partners are also encouraged to initiate collaborations with other Partners. Contact details can be found in the RWD Catalogues under Institutions and Networks by filtering ‘ENCePP partner’.

The Steering Group is established for 3-year mandates. The ENCePP Secretariat organises every third year an election among all ENCePP Partners, and members of the ENCePP network can send an application (excluding UK and EU candidate countries). The election is communicated via the ENCePP website as well as via email to all ENCePP Partner contacts in the RWD Catalogues Institutions/Networks. The SG members are elected by the ENCePP Partners. Further information can be found in the ENCePP SG mandate in the 5.1. Election process section.

ENCePP supports the conduct of studies through several deliverables:

• ENCePP partners have developed research standards in pharmacovigilance and pharmacoepidemiology through written consultation or participation in plenary and working group meetings. The following guidance is available online:
  • The ENCePP Code of Conduct, which provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote transparency and scientific independence throughout the research process.
  • The ENCePP Guide on Methodological Standards in Pharmacoepidemiology, which offers a single web resource for methodological guidance in pharmacoepidemiology.
  • The ENCePP Checklist for Study Protocols, which is a list of questions on important aspects of study design that stimulates researchers to consider important epidemiological principles when designing a pharmacoepidemiological study and that promotes transparency on study methods.
• Historical tools: 
  • ENCePP hosted and maintained the EU PAS Register and the ENCePP Resource Database until 15 February 2024. Both databases were migrated to the HMA-EMA Catalogues of real-world data sources and studies, moving away from the oversight of ENCePP.
  • The ENCePP Seal was discontinued in February 2025. See details in the statement.

The aim of the ENCePP Code of Conduct is to provide a set of rules and principles for the conduct of pharmacoepidemiology and pharmacovigilance studies. The Code addresses critical areas in the planning, conduct and reporting of studies and provides a set of principles and recommendations to promote scientific independence and transparency of observational research and for the interaction between investigators and study funders.

The use of the Code is voluntary and highly recommended. 

The principles within the Code are universally applicable. There are thus no geographical restrictions as regards the use of the Code.

The Code aims to complement existing legislation and associated rules and guidelines by providing a set of rules to which researchers and study sponsors must adhere in order to achieve scientific independence and transparency. It does not replace existing relevant legislationor regulatory guidance.

Use of the Code is considered mandatory in certain situations, for example if an obligation to adhere to the Code has been agreed in the research contract.

The Steering Group agreed to discontinue the ENCePP Seal as of February 2025. More information can be found in the Steering Group statement. Historical information on the Seal Can be found on the ENCePP Seal page. Studies that had been awarded an ENCePP Seal before February 2025 are not impacted, and the Seal remains flagged in the EMA-HMA Catalogue of RWD studies.