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Background information
Irmgard Eichler, MD
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
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Paediatric Committee (PDCO)
27 Members (plus
alternates)
including 5 from Approval Committee
(CHMP)
1 Chair elected
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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
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What is a PIP (paediatric investigation plan)?
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What is a Waiver?
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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.”
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Introduction and background
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Mission statement
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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.
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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
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Breakdown of networks by type and category
NIHR-MCRN EBMT
Network for
Research in
PENTI Pediatric Critical
Care INN GRIP
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What Enpr-EMA does not do
• fund studies
Coordinating EC
(DG)
Group (20)
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Coordinating Group
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Main Stakeholders
➣ Pharmaceutical Industry
➣ Patients, parents and patient organisations
➣ National Competent Authorities
➣ Ethics Committees
➣ Medical devices industry
➣ CRO’s
➣ Hospital pharmacists
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Interaction with stakeholders
• Virtual meetings
• Mail exchange
• Scientific/regulatory conferences
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Networks
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What Enpr-EMA can offer to industry
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Enpr-EMA information: http://www.ema.europa.eu
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Brochure
Thank you - Questions ??