Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements
Course - Berlin, Germany
Medicines and devices for children are an active and rapidly growing area of pharmaceutical research and development in response to requirements by FDA in 1997 and EMEA in 2007. Increased pressure to conduct trials in children can be daunting when faced with practical, legal and clinical considerations found only in pediatric trials. Successfully implementing regulations and ethical standards into study conduct requires a comprehensive understanding of the unique concerns raised by ethics committees, investigators and parents
This course will review a process for closing the gap between regulatory requirements and study execution. Participants will acquire strategies for risk management in the areas of regulatory compliance, protocol execution and participant safety. Guidance documents important to pediatric research will be reviewed within the context of case studies from completed programs. Participants will be given an opportunity to share their experience during working sessions on protocol design and ethical issues.
In addition, there will be ample time to address specific problems and questions of individual participants.
(Courtesy of Hilton Berlin, via commons.wikimedia.org)
Pediatric Clinical Trial Design - Ethics, Management and Regulatory ...
Mon, May 13, 2013 - Tue, May 14, 2013
The Berlin Hilton, Mohrenstrasse 30, Berlin, Germany
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