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| European Network of Paediatric Research at the European Medicines Agency | |
|---|---|
| Name | European Network of Paediatric Research at the European Medicines Agency |
| Abbreviation | ENPR-EMA |
| Formation | 2010 |
| Headquarters | London |
| Parent organisation | European Medicines Agency |
| Region served | European Union |
European Network of Paediatric Research at the European Medicines Agency The European Network of Paediatric Research at the European Medicines Agency is a consortium established to support clinical trials and studies for paediatric medicines, linking regulatory frameworks with academic and industry stakeholders. It operates within the policy context of European Union, interacts with agencies such as the European Medicines Agency, and aligns with legislation like the Paediatric Regulation (EC) No 1901/2006 and directives from Council of the European Union.
The network was launched following policy developments driven by the European Commission and recommendations from the European Parliament and the Committee on the Environment, Public Health and Food Safety, responding to concerns raised by stakeholders including World Health Organization, European Centre for Disease Prevention and Control, and national regulators such as Medicines and Healthcare products Regulatory Agency and Agence nationale de sécurité du médicament et des produits de santé. Early milestones include alignment with initiatives from European Scientific Committee on Emerging and Newly Identified Health Risks and interactions with projects funded by the Horizon 2020 programme and predecessors like the Seventh Framework Programme. Implementation drew on precedents from international efforts such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and collaborations with the U.S. Food and Drug Administration and European Federation of Pharmaceutical Industries and Associations.
Governance structures reflect links to the European Medicines Agency Executive Director, advisory bodies like the Paediatric Committee (PDCO), and oversight from the European Commission DG SANTE, with engagement from national agencies including Agenzia Italiana del Farmaco and Bundesinstitut für Arzneimittel und Medizinprodukte. The network’s board and steering groups include representatives from academic centres such as Great Ormond Street Hospital, research networks like European Society for Paediatric Research, and industry stakeholders including GlaxoSmithKline, Pfizer, and Novartis. Legal and ethical frameworks reference instruments such as the Charter of Fundamental Rights of the European Union and standards propagated by Council of Europe bodies and ethics committees modeled on norms from Declaration of Helsinki.
Primary objectives include improving paediatric medicine availability, harmonising trial methodologies, and supporting regulatory submissions to bodies like the European Medicines Agency and national competent authorities such as Agence Nationale de Sécurité du Médicament. Activities encompass coordinating multicentre clinical trials, providing methodological guidance echoing standards from European Network for Health Technology Assessment and developing paediatric investigation plans influenced by Paediatric Regulation (EC) No 1901/2006. The network facilitates training linked to institutions like University College London, disseminates best practice from organisations including European Society for Paediatric Oncology, and contributes to pharmacovigilance efforts coordinated with EMA Pharmacovigilance Risk Assessment Committee.
Members include university hospitals such as Great Ormond Street Hospital, research consortia like European Clinical Research Infrastructure Network, patient organisations exemplified by European Patients' Forum, and industry partners including AstraZeneca and Roche. Participation criteria mirror standards used by European Research Council grants and are assessed against capacities similar to those required by European Medicines Agency authorised centres and national ethics committees like those in France and Germany. Observer relationships have been maintained with international agencies including World Health Organization Regional Office for Europe and regulatory counterparts like the U.S. Food and Drug Administration.
Research infrastructure integrates clinical trial networks comparable to European Multicentre Study Group for Adult Respiratory Failure and data standards influenced by European Medicines Regulatory Network, biobanking practices akin to European Society for Human Genetics repositories, and trial methodologies reflecting guidance from CONSORT and ICH E6 (R2). The network promotes adaptive trial designs related to innovations from Innovative Medicines Initiative projects and supports data sharing compatible with frameworks developed by European Genome-phenome Archive and European Open Science Cloud.
The network collaborates with pharmaceutical companies such as Sanofi and Bayer, academic consortia like European Society for Paediatric Research, funders including European Commission programmes and foundations such as Wellcome Trust, and patient advocacy groups including EURORDIS and European Cystic Fibrosis Society. Strategic partnerships extend to regulatory bodies including European Medicines Agency committees, international research initiatives like Global Research in Pediatrics, and standard-setting organisations such as International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
Impact includes increased paediatric authorisations processed by the European Medicines Agency and enhanced research capacity within networks resembling European Clinical Research Infrastructure Network, contributing to medicines for conditions highlighted by European Commission public health priorities. Criticism has focused on perceived industry influence mirrored in debates involving European Federation of Pharmaceutical Industries and Associations, concerns about bureaucratic complexity reminiscent of criticisms of the European Medicines Agency processes, and calls from patient groups such as European Patients' Forum for greater transparency and faster translation of trial results into clinical practice.
Category:Paediatric medicine Category:European Medicines Agency