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The Workshop

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Conducting paediatric clinical trials in the European Union: the regulatory, scientific, and ethical roadmap

Date:

Thursday 2 October

Led by:

Francis P. Crawley
Executive Director,
Good Clinical Practice Alliance – Europe (GCPA)
and Member
Ethics Working Group, European Academy of Paediatrics (formerly CESP), Union of European Medical Specials (UEMS)
Joseph Irwin
Trustee and Research Committee Member
The Jennifer Trust for Spinal Muscular Atrophy

About the workshop:

This workshop presents a roadmap for effectively designing, conducting, and registering paediatric clinical trials in the EU. It examines the current framework for clinical trials following the 1996 regulation on Medicines for Paediatric Use and the resulting development over the past two years of paediatric clinical trials infrastructure. It focuses on the development of capacity within the European Medicines Agency (EMEA), the establishment of European networks for paediatric clinical trials and the ongoing development of an ethical framework for paediatric research. Particular attention is given to the role of the Paediatric Committee (PDCO) at the EMEA and the development of a Paediatric Investigation Plan (PIP) in order to meet EU regulatory requirements. The relationship between the current regulatory framework and advanced modelling techniques (PK-PD modelling, first-in-children studies, exploratory paediatric studies) is also discussed.

 

Workshop agenda
08:30

Registration
09:00

The development of an EU framework for paediatric clinical trials
Integrating:

  1. the EU clinical trials directive and preparatory steps
  2. the US framework for advancing paediatric clinical trials
  3. establishing European paediatric research networks
  4. early discussions and the developing European context
09:40

The regulatory framework for EU paediatric clinical trials

  1. the 1996 regulation on Medicines for Paediatric Use
  2. the role of the EMEA
  3. the development of the Paediatric Committee (PDCO) at the EMEA
  4. current paediatric developments in the EU: the EU Database on Clinical Trials (EudraCT)
10:20

Morning refreshments
10:50

The EU ethical framework for research on children

  1. working group on ethics, Union of European Medical Specialists – European Academy of Paediatrics (UEMS-EAP) [formerly CESP]
  2. the European Commission guidance on ethical considerations in paediatric clinical trials
  3. the GCPA partnership for ethics on EU paediatric clinical trials
  4. informed consent and ethical review: specific considerations
11:30

The Paediatric Investigation Plan

  1. the European Commission guideline on the PIP
  2. the basic consi
  3. derations for a PIP
  4. the current regulatory framework and advanced modelling techniques (PK-PD modelling, first-in-children studies, exploratory paediatric studies)
  5. submitting and following a PIP
12:10

Discussion and questions: review of the session
12:30

Close of workshop

 

  

 
About your workshop leaders:

Francis Crawley

Francis Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe and a WHO expert in ethics. He is the co-founder and steering committee member of the Strategic Initiative for Developing Capacity in Ethical Review. In 1993 he specialised as a philosopher in ethical, legal, and regulatory issues concerning health research and has taught at several universities across the globe.

Since 1999 Francis has been a member of the Working Group on Ethics, Union of European Medical Specialists – European Academy of Paediatrics. He was a member of the steering committee for the European Commission project EUROSOCAP and currently represents the GCPA on the EC Public Health and FP7 research projects, nEUroped and RESPECT. Francis is also an honorary member of the Faculty of Pharmaceutical Medicine, Royal College of Physicians in the UK.
Joseph Irwin Joseph Irwin is a Trustee of the Jennifer Trust for Spinal Muscular Atrophy and was their first Honorary Director of Research. He is team leader for the SMA EUROPE Project Butterfly which is seeking to co-ordinate research and development activities with the clinical and scientific community for treatments of Spinal Muscular Atrophy. In addition, Joseph is on the Paediatric Task Force for the European Organisation for Rare Disorders.

Joseph, who is a biochemist-pharmacologist with molecular biology and cell biology experience, has worked for many years in hospital based research and for the pharmaceutical industry. Joseph is a consultant on regulatory matters.
The Jennifer Trust for Spinal Muscular Atrophy The Jennifer Trust for Spinal Muscular Atrophy is the only national charity in the UK dedicated both to supporting people affected by SMA, and investing in essential research into causes, treatments, and eventually a cure for the disease.

The condition affects people of all ages, race or background. The Jennifer Trust aims to provide support to any child, adult or family affected by SMA. We presently offer support to over 3,670 adults and 1,830 children whose lives have been affected by the condition. www.jtsma.org.uk