Description
The ICH E11 guideline changed the environment of drug development for the pediatric population. In this session the speaker will provide a basic overview of pediatric clinical research to include the specifics written in the ICH E11 guideline and the rationale for the revision based on the FDA’s input. The session will be beneficial for all clinical research professionals working in pediatric trials or those with an interest in the topic.
Learning Objectives:
- Discuss the FDA’s input into ICH E-11 and the rationale for E11(R1).
- Recite four ethical considerations for pediatric studies.
- Debate the use of chronological age versus categories for clinic research.
Speaker(s):
- John
Rowell,
RN, MSN,
Principal Owner,
Bio Research Consulting LLC
