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An agency of the European Union Enpr-EMA European Network of Paediatric Research at the European Medicines Agency Background information Irmgard Eichler,

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Presentation on theme: "An agency of the European Union Enpr-EMA European Network of Paediatric Research at the European Medicines Agency Background information Irmgard Eichler,"— Presentation transcript:

1 An agency of the European Union Enpr-EMA European Network of Paediatric Research at the European Medicines Agency Background information Irmgard Eichler, MD

2 2 European Paediatric Regulation Improve the health of children Increase high quality research into medicines for children Increase availability of authorised medicines for children Increase information on medicines Avoid unnecessary studies in children Avoid delaying authorisation for adults Main Pillars of the Regulation: - the paediatric committee (PDCO) - the paediatric investigation plan (PIP) ©EMA

3 3 Paediatric Committee (PDCO) 27 Members (plus alternates) including 5 from Approval Committee (CHMP) 2 from Norway, Iceland 3 Patient representatives 3 HealthCare Professionals 1 Chair elected ©EMA

4 4 Paediatric Committee members Anaesthesiology, neonatology, cardiology, immunology, transplantation, respiratory, ICU, haematology, oncology, endocrinology and diabetes, adolescent medicine, infectious diseases, gastroenterology and nutrition, general paediatrics, methodology, pharmacology, pharmacovigilance, vaccines Formulation Working Group Non-clinical Working Group Extrapolation Working Group ©EMA

5 5 European Paediatric Regulation Improve the health of children Increase high quality research into medicines for children Increase availability of authorised medicines for children Increase information on medicines Without unnecessary studies in children Without delaying authorisation for adults Main Pillars of the Regulation: - the paediatric committee (PDCO) - the paediatric investigation plan (PIP) ©EMA

6 6 What is a PIP (paediatric investigation plan) ? Details of the measures and timing to demonstrate: - Quality - Efficacy - Safety Basis for development and authorisation of a medicinal product for children To be agreed by the PDCO Binding on company compliance check Marketing Authorisation Criteria PIP ©EMA

7 7 What is a Waiver? EMA Decision waiving the need for paediatric development of the product in a certain condition Can apply to some or all subsets of paediatric population List of class waivers (conditions) Product-specific waivers because of - Probable lack of efficacy, or safety concern - Disease/condition occurring only in adult population - Lack of significant therapeutic benefit PIP ©EMA

8 8 Unless an EMA decision on a Paediatric Investigation Plan or waiver is included, the validation of a marketing authorisation application – even for adults only – will be refused. European Paediatric Regulation ©EMA

9 9 Introduction and background Legal basis European Paediatric Regulation: The EMA shall, with the scientific support of the Paediatric Committee, develop a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population. ©EMA

10 10 Introduction and background Enpr-EMA is a network of research networks, investigators and centres with recognised expertise in performing clinical trials in the paediatric population Members perform research with children (newborns to adolescents), in multiple therapeutic areas, and ranging from pharmacokinetics to pharmacovigilance ©EMA

11 11 Mission statement Enpr-EMA will facilitate studies in order to increase availability of medicinal products authorised for use in the paediatric population. ©EMA

12 12 Mission statement This will be achieved by: Fostering high quality ethical research on the safety and effectiveness of medicines for children. Efficient inter-network and stakeholder collaboration in order to build up necessary competences at EU level and to avoid unnecessary duplication of studies. Informing parents, carers, children and young people about clinical trials and encourage their participation. Raising awareness among health care professionals of the need for clinical trials in all ages of children and supporting their involvement in such studies. Assisting and entering into discussion with ethics committees on issues relevant to research and clinical trials in children. ©EMA

13 13 Recognition criteria Networks to be recognised by quality of paediatric research 6 recognition criteria and quality standards for self-assessment Research experience and ability Efficiency requirements Scientific competencies and capacity to provide expert advice Quality management Training and educational capacity to build competences Involvement of patients, parents or their organisations Each criterion composed of several sub items Set of minimum criteria to be fulfilled Self-assessment to updated annually ©EMA

14 EBMT NIHR-MCRN GRIP PENTI 14 Breakdown of networks by type and category Network for Research in Pediatric Critical Care INN © EMA Category 1: Networks fulfilling all minimum criteria for membership of Enpr-EMA. Category 2: Networks potentially fulfilling all minimum criteria – but needing to clarify some issues before becoming a member of Enpr-EMA. Category 3: Networks currently not yet fulfilling minimum criteria.

15 What Enpr-EMA does not do fund studies act as a CRO and manage studies decide on research priorities which remain the responsibility of –the Member States –the Commission through the Community programmes –each individual network ©EMA

16 Coordinating Group (20) Co-chaired by EMA + elected member 3 year membership EC (DG) Structure - Coordinating Group ©EMA

17 17 Coordinating Group Role of the Coordinating Group: to contribute to the short and long-term strategy of the network to address operational and scientific issues for the network to agree scientific quality standards to act as a forum for communication ©EMA

18 Pharmaceutical Industry Patients, parents and patient organisations National Competent Authorities Ethics Committees Medical devices industry CROs Hospital pharmacists Main Stakeholders ©EMA

19 Interaction with stakeholders Annual workshop – open to all stakeholders Virtual meetings Mail exchange Scientific/regulatory conferences ©EMA

20 Why should you join Enpr-EMA ? increase visibility as potential site(s) for industry-sponsored studies (requested by PDCO) gain access to SMEs for collaboration present your centre/network - at a European level save resources by sharing work, avoiding duplication share skills and expertise with other centres/networks shape the future development in paediatric research access information on EC framework programmes ©EMA Networks

21 What Enpr-EMA can offer to industry Pool of patients for inclusion Speeding up recruitment Expert advice - treatment options (standard of care) - paediatric needs - feasibility of paediatric clinical trials Access to academic partners through collaboration with the SME office at EMA 21 ©EMA

22 22 Enpr-EMA information: http://www.ema.europa.eu ©EMA

23 Scroll down to ©EMA

24 24

25 Brochure

26 Thank you - Questions ??


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