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 objectives are to:
- foster high-quality, ethical research on the quality, safety and efficacy of medicines for use in children;
- enable collaboration between networks and and stakeholders;
- coordinate studies relating to paediatric medicines and avoid unnecessary testing in children;
- build up scientific and administrative competence at a European level;
- help with the recruitment of patients for clinical trials;
- promote 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 is responsible for ensuring collaboration within Enpr-EMA.
Fostering research on medicines for use in children is one of the objectives of the EU Paediatric Regulation.
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 criteria:
- 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.
For the full list of members, see Enpr-EMA membership.
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:
- First workshop on European paediatric network (16/02/2009)
- Second workshop on European paediatric network (16/03/2010)
- Third workshop on European network of paediatric research at the European Medicines Agency (10-11/03/2011)
- Fourth workshop on European network of paediatric research at the European Medicines Agency (22-23/03/2012)
- Fifth workshop on European network of paediatric research at the European Medicines Agency (27-28/06/2013)
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.
Collaboration with micro, small and medium-sized enterprises (SMEs)
In addition to the requirements set out in the Paediatric Regulation, 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 (updated)
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:
- 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.
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. Networks interested in joining Enpr-EMA had until the end of July 2010 to complete a self-assessment form.
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.
- European Network of Paediatric Research at the European Medicines Agency - Background information (22/10/2012)
- European Network of Paediatric Research at the European Medicines Agency (22/05/2013)
- Mission statement of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (24/02/2012)
- The network of paediatric networks at the European Medicines Agency: Implementing strategy (15/01/2008)