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Session 5: Information and Case Studies Related to ICH E11A draft guidance on Pediatric Extrapolation
Session Chair(s)
Brenda Crowe, PHD
Associate Vice President, Statistics, Eli Lilly and Company, United States
Yun Wang, PHD
Deputy Division Director, CDER/OTS/OB, FDA, United States
The ICH E11A draft guidance on pediatric extrapolation was released in April 2022 for public consultation. It has received many public comments during up until the deadline of October 2022. The purpose of this guideline is to provide recommendations for, and promote international 5 harmonization of, the use of pediatric extrapolation to support the development and 6 authorizations of pediatric medicines. Speakers in this session will discuss issues, content and case studies related to the ICH E11A guidance. The presentations will be followed by a panel discussion.
Learning Objective : At the conclusion of this session, participants should be able to:
- Summarize the main points of the draft guidance
- Discuss issues related to the guidance
- Apply principles of ICH E11A draft guidance to pediatric drug development
Speaker(s)
James Travis, PHD
Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
Implementation of Pediatric Extrapolation
Andrew Thomson, PHD, MA, MS
Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Speaker
Mark Rothmann, PHD
Division Director, OTS, OB, CDER, FDA, United States
Panelist
Yeruk (Lily) Mulugeta, PHARMD
Associate Director, Division of Pediatric and Maternal Health, CDER, FDA , United States
Panelist
Sabine Fuerst Recktenwald, DrMed, MD
Principal Medical Director PHC Safety Interface Team, F.HOFFMANN LA ROCHE LTD, Switzerland
Panelist
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