ENCePP Q&A

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network coordinated by the European Medicines Agency. The members of this network (the ENCePP partners) are public institutions and contract and research organisations (CRO) involved in research in pharmacoepidemiology and pharmacovigilance. Research interests include the assessment of benefits and risks of medicines, disease epidemiology and drug utilisation. Participation to ENCePP is voluntary.

ENCePP aims to strengthen the monitoring of the benefit-risk balance 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;
• Developing and maintaining methodological standards and governance principles for research in pharmacovigilance and pharmacoepidemiology.

ENCePP’s main stakeholders include the research community, regulatory and public health authorities, patients and health care professional associations, and the pharmaceutical industry. The ENCePP website describes the activities of the network and provides access to its meeting documents and reports.

ENCePP originates from the European Medicine Agency’s endeavor to enhance scientific and operational expertise in the fields of pharmacoepidemiology and pharmacovigilance across Europe. The project started in 2006 and is a key initiative within the European Risk Management Strategy (ERMS) adopted by Heads of Medicines Agencies, which aims to apply a proactive approach to monitoring of medicines throughout their lifecycle. Instrumental to this was the establishment of a network gathering available expertise and research experience in the fields of pharmacoepidemiology and pharmacovigilance across Europe.

ENCePP focuses on public and not-for-profit organisations located in one of the EU or EFTA countries. These can be research centres, pharmacovigilance centres, university hospitals, owners of healthcare databases and/or electronic registries. 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.

Existing European networks (e.g., certain rare diseases, therapeutic fields, or adverse drug events) may also join ENCePP if at least one of its members is registered as an ENCePP centre.

Pharmaceutical companies cannot be ENCePP partners, but they are encouraged to make use of the resources offered through the ENCePP networks.

You will need to register your institution or network in the HMA-EMA Catalogues and tick 'yes' to the ENCePP partner question. 

Being an ENCePP partner means a commitment to

• adhere to the principles of the ENCePP Code of Conduct and ENCePP Guide on Methodological Standards in Pharmacoepidemiology,
• register non-interventional studies the ENCePP partners are conducting in the EMA-HMA catalogue of non-interventional studies,
• participate in the development of research and good practice standards by contributing to, or commenting on, draft proposals prepared by working groups or the ENCePP secretariat,
• collaborate with other ENCePP partners, e.g., in multi-centres studies, and share their research experience.

ENCePP supports the conduct of pharmacovigilance or pharmacoepidemiological 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.

• A publicly available and searchable resource database (EMA-HMA catalogue of data sources), an electronic index of self-registered EU research organisations, networks and data sources in the field of pharmacoepidemiology and pharmacovigilance that can be used by researchers and study sponsors seeking to identify organisations and data sets for conducting specific pharmacoepidemiology and pharmacovigilance studies in Europe.
• A publicly available and searchable register (EMA-HMA catalogue of non-interventional studies) where any pharmacoepidemiological and pharmacovigilance study can be registered by whoever initiates.In this catalogue the marketing authorisation holders should register all non-interventional post-authorisation safety studies (PASS) relating to medicines.
• The ENCePP Seal that recognises studies following the ENCePP principles of standards, transparency and independence.

ENCePP supports the conduct of high-quality industry-funded post-authorisation studies (PAS) by:

• Supporting the conduct of joint studies by facilitating collaborations; 
• Providing opportunities to participate, through consultations, in the development of pharmacoepidemiological research standards and methods for the post-authorisation safety surveillance of medicinal products;
• Developing and maintaining methodological, transparency and governance tools for the planning, design, conduct and reporting of studies according to standards recommended in the EU Good Pharmacovigilance Practices (GVP) and the ENCePP Code of Conduct.

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. However, it is mandatory to follow the Code for studies seeking the ENCePP Seal.

The Code of Conduct applies to the conduct of a study from its planning stage to final results. Researchers are encouraged to adhere to the principles of the Code for both ongoing and prospectively planned studies, but will be unable to apply for the ENCePP Seal  retrospectively if the study has already started.

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

The principles of the Code of Conduct are applicable to all pharmacoepidemiological or pharmacovigilance studies. The Code addresses common issues encountered in industry commissioned research, in particular commercial, financial or institutional interests that could influence the outcome of a study in any particular direction. The Code also provides for research conducted with authorised medicines in the context of post-approval regulatory requirements of marketing authorisation holders.

The Code aims to complement existing legislation and associated rules and guidelines by providing a set of rules to which researchers and study funders must adhere in order to achieve scientific independence and transparency. It does not replace existing relevant legislation (e.g., Clinical Trials Regulation (Regulation (EU) No 536/2014) in the case of clinical trials) or regulatory guidance published by the European Medicines Agency (EMA) such as EU Good Pharmacovigilance Practices (GVP) in which the Code is referenced e.g. in GVP Module VIII on post-authorisation safety studies (PASS).

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