Event Date/Time: Apr 16, 2007
End Date/Time: Apr 17, 2007
Paediatric clinical research has lagged behind adult research for decades. Legislation has been developed in the US and EU which requires pharmaceutical companies to perform clinical trials on paediatric patients. Many investigators, study coordinators, and pharmaceutical employees are very motivated but are research naïve with regards to this unique niche population. Many aspects of paediatric research will be discussed, including the present and future of paediatric clinical trials. Regulatory requirements from both EMEA and FDA for pediatric clinical research including the differences and similarities and how to meet the dual approval processes will be covered. There will be a full range of training provided including protocol development, medical monitor role, drug formulation, drug dosing, analysis and results. Also the lessons learned from two paediatric trials will be discussed.