Paediatric Drug Development
The Rubens at the Palace Hotel
39 Buckingham Palace Road
London, United Kingdom SW1W 0PS
Keywords: Paediatric Drug Development, Informa Life Sciences

Schedule of Presentations:

Tuesday, September 29, 2009
09:00:00 Opening remarks from the Chair
09:10:00 Industry Viewpoint: Examining the impact of the EMEA guidelines on paediatric drug development Jan Gross
09:50:00 Regulators viewpoint: Complying with content and structure requirements for the Paediatric Investigational Plan Dirk Mentzer
10:30:00 Morning coffee
11:00:00 Industry viewpoint: Practical insight into how to comply with EU regulations for paediatric drug development Philippe Auby
11:40:00 Successfully integrating paediatrics into the general drug development process Klaus Rose
12:20:00 Getting to grips with the legal framework and practical implications of the EMEA guidelines Sally Shorthouse
13:00:00 Lunch
14:10:00 Developing and implementing successful preclinical studies for first in children trials Klaus Olejniczak, Nigel Room
15:30:00 Afternoon coffee
16:00:00 Pharmacokinetics, dynamics and metabolism in children David McIntosh
16:20:00 Regulatory Panel Discussion Dirk Mentzer, Klaus Olejniczak
17:20:00 Closing remarks from the Chair
17:30:00 End of Day One
Wednesday, September 30, 2009
09:20:00 Opening remarks from the Chair
09:30:00 Designing a combined approach to global paediatric healthcare challenges Vijay Tammara
10:10:00 Optimising Paediatric formulation and drug delivery
10:50:00 Morning coffee
11:20:00 Case study: Key considerations for efficient and ethical paediatric informed consent processes in clinical trials Adrian Liepins
12:00:00 Meeting the challenge of ethical paediatric patient recruitment and retention Jane Lamprill
12:40:00 Lunch
13:50:00 How to harmonise some crucial aspects in paediatric clinical trials Joachim Boos
14:30:00 Developing health economic data as part of a paediatric clinical trials program Suyash Prasad
15:10:00 Afternoon coffee
15:40:00 Building compliant safety study designs in paediatric populations Nawab Qizilbash
16:20:00 Panel discussion on today’s findings
16:40:00 Chair’s closing remarks and end of conference
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