Learning Objectives

Upon completion of this course, attendees will have gained the background knowledge necessary to apply general principles of ethical and practical approaches for studies in children to trials in specific pediatric therapeutic areas. Participants will understand regulatory agency expectations for pediatric use information and the impact of regulatory decisions on trial feasibility in child populations.

Course Description

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.

Benefits of the class include:

• A resource CD with regulations, guidance documents and a bibliography of peer-reviewed manuscripts on pediatric trials
• Opportunities to present blinded case studies for classroom discussion
• Individualized discussion with the course director on specific issues during breaks

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