9th Annual Biomarkers Congress
Paediatric Clinical Trials
Copthorne Tara Hotel
Scarsdale Place
London, London
http://www.smi-online.co.uk/events/programme.asp?is=4&ref=3910
, Copthorne Tara Hotel
SMI Conferences
http://www.smi-online.co.uk/events/programme.asp?is=4&ref=3910
Scarsdale Place
London

Schedule of Presentations:

Wednesday, March 21, 2012
08:30:00 Registration & Coffee
09:00:00 Chairman's Opening Remarks
09:10:00 The European paediatric legislation: an assessment in its 6th year
09:50:00 Medicines for children: regulatory aspects Hans Stoetter
10:30:00 Morning Coffee
11:00:00 Considerations for developing and executing a PIP
11:40:00 Management of PIP and incentives for industry Sarah Pinder
12:20:00 Networking Lunch
13:50:00 An update on the United States paediatric clinical research legislation Eric Hassall
14:30:00 Technical approaches and experiences in developing therapies for children
15:10:00 Afternoon Tea
15:40:00 Pharmacokinetic/Pharmacodynamic modelling of paediatric data Joseph Standing
16:20:00 Non-clinical testing to assess potential for toxicity Georg Schmitt
17:00:00 Chairman’s Closing Remarks and Close of Day One Klaus Rose
Thursday, March 22, 2012
08:30:00 Registration & Coffee
09:00:00 Chairman's Opening Remarks Jane Lamprill
09:10:00 Safety management teams (SMT): Evaluating the safety specification from a paediatric perspective
09:50:00 Paediatric drug development: Challenges in trial design and operational efficiency Philippa Smit Marshall
10:30:00 Morning Coffee
11:00:00 Strategies to optimise ethics review of paediatric study protocol Jane Lamprill
12:10:00 Blood sampling in paediatrics: Sponsor point of view
12:40:00 Networking Lunch
13:50:00 Practical aspects of assent and consent - German templates Thorsten Ruppert
14:30:00 Paediatric vaccine development David McIntosh
15:10:00 Afternoon Tea
15:40:00 Conducting effective studies across networks Dirk Matthys
16:20:00 Practical guidance for phase III and IV paediatric trials Philippe Auby
17:00:00 Chairman’s Closing Remarks and Close of Day Two Jane Lamprill
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