The Association of Clinical Research Professionals

Pediatric Research: FDA’s 2017 Adopted Version of ICH E11 Resulting in E11(R1)

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.


This program is a recorded session from ACRP 2019