European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)

EnprEMAThe 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 enables networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry.

It acts as a platform for sharing good practices as well as a pan-European voice for promoting research into medicines for children.

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.

For more information, see:

Enpr-EMA network database

Enpr-EMA maintains a database of its member research networks and centres. The database is fully searchable and provides easy access to data about each Enpr-EMA network:

Objectives

Enpr-EMA's main objective is to facilitate studies in order to increase the availability of authorised medicines for children. It works by:

  • establishing a European paediatric research network of national and European specialist networks, investigators and centres with expertise in performing paediatric clinical trials to foster high-quality, ethical research on the safety and effectiveness of medicines for children;
  • efficient inter-network and stakeholder collaboration, to build up the necessary competences at European Union (EU) level, and to avoid unnecessary duplication of studies;
  • raising awareness among healthcare professionals, parents, carers, children and young people of the need and support for paediatric clinical trials;
  • assisting and entering into dialogue with ethics committees on issues relevant to research and clinical trials in children.

For more information, see Enpr-EMA priority activities.

EMA role

EMA is responsible for:

  • providing secretarial support to the activities of the network;
  • ensuring exchange of information between network partners;
  • providing information to external partners and stakeholders.

Membership

Enpr-EMA members perform research in children, from newborns to adolescents, in multiple therapeutic areas, and ranging from pharmacokinetics to pharmacovigilance

Becoming a member

Networks, centres, or investigators, specialised in paediatrics, and other parties interested in becoming members of Enpr-EMA should complete the self-assessment form on Enpr-EMA Network Database: Contact

To be accepted as a member, a network must demonstrate that it fulfills defined recognition criteria, such as:

  • 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 more information on the recognition criteria, see:

Membership is organised in four categories:

  • category 1 networks fulfil all minimum quality criteria;
  • category 2 networks potentially fulfil all minimum criteria but in need of further clarifications;
  • category 3 networks do not currently fulfil the minimum criteria;
  • category 4 networks do not run paediatric clinical trials but have expertise in clinical trial methodology or support infrastructure.

Category 1 networks are part of the operational centre of Enpr-EMA, sharing responsibility for the network's long- and short-term strategy. For more information, see:

Workshops

Enpr-EMA holds annual workshops at EMA's premises to discuss requirements, barriers and opportunities for high-quality clinical studies in children. They are open to all stakeholders.

These workshops enable Enpr-EMA to set priority tasks for the following year, based on feedback from stakeholders.  

Further information and meeting materials are available on the meeting pages:

Enpr-EMA also organises subject-specific ad-hoc workshops, in line with its priority tasks:

Newsletters

Enpr-EMA regularly publishes newsletters to provide updates on its activities to its members and stakeholders:

For more information, see Enpr-EMA priority activities.

Guidance for medicine developers

Enpr-EMA members can offer pharmaceutical companies advice and expert information during all stages of paediatric medicine development.

Enpr-EMA recommends, in particular, that medicine developers involve paediatric research networks when developing a paediatric investigation plan.

Enp-EMA has published guidance for pharmaceutical companies on how to engage with paediatric research networks, including information on the services they offer:

Supporting SMEs and academia

Enpr-EMA and EMA's micro, small and medium-sized enterprises (SMEs) office offer support in setting up partnerships between SMEs and academic investigators in paediatric medicine research, as these groups often experience difficulty finding partners that complement their research interests.

To help develop networking opportunities and partnerships, the Enpr-EMA secretariat can provide information on:

  • existing networks, investigators and clinical-trial centres;
  • SMEs looking for academic partners in the paediatric-medicine field.

Registering your project with Enpr-EMA

Enpr-EMA invites networks, investigators and clinical-trial centres looking for pharmaceutical industry partners in the paediatric-medicine field to send the following information about their projects to enprema@ema.europa.eu:

  • title or name of the project or trial;
  • reference code, if applicable;
  • country;
  • 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;
  • email contact point.

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