European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children.
Enpr-EMA's main objective is to facilitate studies in order to increase availability of medicinal products authorised for use in the paediatric population, by:
- fostering high-quality, ethical research on the quality, safety and efficacy of medicines for use in children;
- helping with the recruitment of patients for clinical trials;
- enabling collaboration between networks and stakeholders;
- avoiding unnecessary duplication of studies;
- building up scientific and administrative competence at a European level;
- promoting European Commission framework programme applications.
Enpr-EMA works by allowing networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry. The network does not perform clinical trials or fund studies or research or decide on areas for paediatric research, as this is the responsibility of Member States, the European Commission or each individual member organisation.
The European Medicines Agency (EMA) is responsible for providing secretarial support to the activities of the network ensuring exchange of information between the network partners, as well as providing information to external partners and stakeholders.
More information can be found in the below documents:
Members of Enpr-EMA
The network has members representing various therapeutic areas, age groups and specific activities in paediatric medicine, such as pharmacovigilance.
Enpr-EMA's members must fulfil the requirements laid down in a set of six recognition criteria1:
- research experience and ability;
- network organisation and processes;
- scientific competencies and ability to provide expert advice;
- quality management;
- training and educational capacity to build competencies;
- public involvement.
1 Nicolino Ruperto, Irmgard Eichler, et al. A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA). Arch Dis Child 2012;97:185-188.
Enpr-EMA membership is organised in four categories:
- Category 1: networks fulfilling all minimum quality criteria;
- Category 2: networks potentially fulfilling all minimum criteria but in need of further clarifications;
- Category 3: networks not currently fulfilling the minimum criteria.
- Category 4: networks who do not run paediatric clinical trials but have expertise in clinical trial methodology, or support infrastructure, etc.
Networks, centres, or investigators, specialised in paediatrics, and interested in becoming members of Enpr-EMA are invited to complete the self-assessment form on the Contact page of the Enpr-EMA Network Database
Members and their category can be searched in the Enpr-EMA Network Database.
The operational centre of Enpr-EMA is the Coordinating Group, which is responsible for the network's long- and short-term strategy:
Every year, Enpr-EMA holds a workshop at the European Medicines Agency in London:
- 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (07/06/2018)
- 2017 annual workshop of the European network of paediatric research at the European Medicines Agency (16/05/2017)
- 2016 annual workshop of the European network of paediatric research at the European Medicines Agency (02-03/06/2016)
- 2015 annual workshop of the European network of paediatric research at the European Medicines Agency (28-29/05/2015)
- Sixth workshop on the European network of paediatric research at the European Medicines Agency (26-27/06/2014)
- Fifth workshop on European network of paediatric research at the European Medicines Agency (27-28/06/2013)
- Fourth workshop on European network of paediatric research at the European Medicines Agency (22-23/03/2012)
- Third workshop on European network of paediatric research at the European Medicines Agency (10-11/03/2011)
- Second workshop on European paediatric network (16/03/2010)
- First workshop on European paediatric network (16/02/2009)
Following the fifth annual workshop, several ad hoc working groups (WG) were set up, including network and industry representatives, and tasked with addressing the most important needs identified during the meeting. The purpose of the WGs is to develop pragmatic responses to some of the needs that can be implemented within six to twelve months. The highlights from the work of the working groups are published on the Enpr-EMA activities page.
Collaboration with micro, small and medium-sized enterprises (SMEs)
The need for increased collaboration between industry and academic was outlined in the report on the SME initiative 2006-2011 , particularly in the field of paediatric medicines.
Enpr-EMA and the Agency's SME office are now acting as liaison between SMEs and academic investigators in paediatric-medicine research, both of which experience difficulty finding partners that complement their research interests.
The Agency invites networks, investigators and clinical-trial centres that are looking for industry partners in the paediatric-medicine field to send information about their projects to firstname.lastname@example.org with the following information:
- title or name of the project or trial;
- reference code, if applicable;
- product, substance or technology under study;
- therapeutic field;
- age range of the study population;
- development of (new) paediatric formulations;
- cooperation requested: type of partner sought and tasks to be performed;
- e-mail contact point.
The Enpr-EMA secretariat will relay this information to the SME office to help develop networking and partnering opportunities.
The Enpr-EMA secretariat will also update the networks regularly with information received from SMEs looking for academic partners in the paediatric-medicine field.
Involvement of young people and families in the Enpr-EMA networks
Engaging and involving young people and family members in clinical research has many benefits, including greater understanding of young people's perspectives, and improvements in study design and the quality of clinical research.
A survey on the involvement of young people and family members in Enpr-EMA paediatric research networks was sent to all 39 Enpr-EMA networks in August 2012. Outcomes in December 2012 indicated that, although more than half of the networks that responded actively involve young people or families, only three networks out of 39 had developed strategies or guidelines for the involvement of young people and families, which are published below for further information:
- National Institute for Health Research, United Kingdom: Medicines for Children Research Network consumer strategy 2012 - 2015;
- Scottish Children's Research Network, United Kingdom: Young Persons' Group strategy documentation;
- Maternal Infant Child and Young Research Network, Canada: Creating and connecting networks.
In November 2014 a survey was conducted among the PDCO members to gather their views in relation to the engagement of young people and families, their potential involvement in the activities of the PDCO and the strengthening of the participation for members representing patients' organisations in the Committee.
Collaboration with ethics committees
As of 2017, Enpr-EMA and the European Network of Research Ethics Committees (EUREC) are exploring ways of collaboration. As a first step, Enpr-EMA and EUREC will collect ideas for collaboration and collect a survey on needs and expectations among their members.
Enpr-EMA works with international partners specialising in the regulation of medicines for children. It works with:
- World Health Organization (WHO) through the European Medicines Agency's membership of the Paediatric Medicines Regulators' Network (PmRN);
- United States Food and Drug Administration (FDA) through the Agency's existing interaction on paediatric therapeutics .
History of Enpr-EMA
The European Medicines Agency set up Enpr-EMA in accordance with the Paediatric Regulation, which aims to improve the health of children in the EU. The Agency's Management Board adopted an implementing strategy for the network on 15 January 2008.
In May 2010, participants from 38 national research networks and clinical trial centres and the European Medicines Agency agreed an organisational structure for the network.
In the same month, membership of Enpr-EMA was opened to networks that fulfil the requirements laid down in the recognition criteria. Following assessment of the responses, the Agency published a full list of the networks that applied for Enpr-EMA membership in January 2011, indicating those that met all of the criteria and those that needed to provide further clarification or did not yet qualify.
In January 2014, the EMA published a fully searchable database of Enpr-EMA registered networks. The database is regularly updated with new members joining Enpr-EMA.