The Workshop

Updating EU regulatory and ethical issues for conducting paediatric clinical trials

Monday 16 November 2009

Francis P. Crawley
Executive Director,
Good Clinical Practice Alliance – Europe (GCPA)

This half day workshop will present an overview of the current regulatory and ethical issues for effectively designing, conducting, and registering paediatric clinical trials in the European Union (EU). It will examine the current framework for clinical trials, following the 2006 Regulation on Medicines for Paediatric Use, and the resulting development over the past three years of a paediatric clinical trials infrastructure in the EU. The interactive sessions will cover 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 will be 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 and exploratory paediatric studies) will be discussed.

Workshop agenda

Registration

The European Union framework for paediatric clinical trials

• The EU Clinical Trials Directive: the regulatory and ethical background
• The US framework for advancing paediatric clinical trials and its impact on the EU
• Current issues arising from the first three years of European experience

The regulatory framework for EU paediatric clinical trials

• The 2006 Regulation on Medicines for Paediatric Use
• The role of the EMEA
• PDCO and the Paediatric Investigation Plan (PIP)
• Current paediatric developments in the EU: the EU database on Clinical Trials (EudraCT)

Afternoon refreshments

The EU ethical framework for research on children

• Working Group on Ethics, Union of European Medical Specialists - European Academy of Paediatrics (UEMS-EAP) [formerly CESP]
• The European Commission guidance on ethical considerations in paediatric clinical trials
• The GCPA partnership for ethics on EU paediatric clinical trials
• Informed consent and ethical review – specific considerations

EU Phase I clinical trials in children

• The EMEA and ABPI guidance on Phase I clinical trials
• Experiences with EU Phase I paediatric clinical trials
• Ethical issues EU Phase I paediatric clinical trials
• Phase I paediatric clinical trials and the PIP

Discussion and questions: review of the session

Close of the workshop

About your workshop leader:

Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance - Europe (GCPA) in Brussels, Belgium and a World Health Organization (WHO) expert in ethics. He is the co-founder and steering committee member of the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). He is a specialised philosopher since 1993 in ethical, legal and regulatory issues concerning health research, teaching at several universities in Europe and other continents.