EU PAEDIATRIC
LEGISLATION

Conference Date: 21-22 Sep 2009
Conference Ref: A9-4409
Fee: £1199 + VAT
Venue: The Rembrandt Hotel, London

The implementation of the new European Paediatric Legislation, has had a major impact on the drug development and regulatory process within the EU.

Are you aware of the significant new requirements and potential rewards relating to the submission of paediatric data?This meeting will provide you with a comprehensive understanding of the new EU Paediatric legislation and of the strategic and practical issues and opportunities that result. The meeting will also provide a valuable opportunity to discuss experience gained to date and will look into the potential future direction of paediatric drug regulation in Europe.

Chaired by:

• Neil Edwards Sirius Regulatory Consulting Ltd

Speakers:

• Dr Sarah Branch MHRA
• Geneviève Michaux Covington & Burling
• Jane Lamprill Paediatric Research Consultancy
• Dr Brian Edwards NDA

Topics to be covered include:

• EU Paediatric Legislation – Hear the Regulator’s Perspective
• Understand the Roles of the Paediatric Committee and EMEA
• What is the Legal Interpretation of the Scope of Paediatric Regulation?
• Is Paediatric Research Mandatory and will it be Rewarded?
• Discuss Approaches for Completing a Successful Paediatric Development Plan
• Understand Nonclinical Considerations in Paediatric Drug Development
• Discuss Practical Aspects of Paediatric Clinical Trial Management
• What are the Special Considerations for PaediatricPharmacovigilance?

Click here to book your place on this important annual event.