| Description |
Pediatric 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 pediatric 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 pediatric research will be discussed, including the present and future of pediatric clinical trials which will be presented by representatives from FDA and NICHD. There will be a full range of training provided including protocol development, medical monitor role, drug formulation, drug dosing, analysis, and results. Lessons learned from two pediatric trials will also be provided.
In addition, the audience will have the opportunity to participate in actual “hands on” development of a pediatric drug development program. There will be Phase I/II and Phase III case studies for group review and discussion. Timing, strategy, analysis, and implementation will be developed with audience participation.
Key Topics
•History of Pediatric Research
•Best Pharmaceuticals For Children Act (BPCA)
•FDA Regulatory Update
•Clinical Trial Development Trial And Implementation
•Lessons Learned
•Case Studies.
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