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 aims to foster high-quality ethical research on quality, safety and efficacy of medicines to be used in children. It does this through networking and stakeholder collaboration with members from within and outside the European Union (EU).

Enpr-EMA's main objectives are to:

• foster high-quality, ethical research on medicines for use in children;
• enable collaboration between networks and and stakeholders;
• co-ordinate 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 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 network.

The European Medicines Agency is responsible for ensuring collaboration within the network.

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:

1. Research experience and ability;
2. Network organisation and processes;
3. Scientific competencies and ability to provide expert advice;
4. Quality management
5. Training and educational capacity to build competences;
6. Public involvement.

For the full list of members, see Enpr-EMA membership.

The operational centre of Enpr-EMA is a coordinating group which is responsible for the network's long- and short-term strategy:

• Enpr-EMA Coordinating Group

Enpr-EMA workshops

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)

International collaboration

Enpr-EMA works with international partners specialising in the regulation of medicines for children.

It works with:

• the World Health Organization (WHO) through the European Medicines Agency's membership of the Paediatric Medicines Regulators' Network (PmRN);
• the 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. 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.