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Virtual

Mar 29, 2023 10:00 AM - Mar 31, 2023 4:15 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 5: Information and Case Studies Related to ICH E11A draft guidance on Pediatric Extrapolation

Session Chair(s)

Brenda  Crowe, PhD

Brenda Crowe, PhD

Associate Vice President, Statistics

Eli Lilly and Company, United States

Yun  Wang, PhD

Yun Wang, PhD

Deputy Division Director

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The ICH E11A draft guidance on pediatric extrapolation was released in April 2022 for public consultation.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  • Summarize the main points of the draft guidance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  • Apply principles of ICH E11A draft guidance to pediatric drug development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

Implementation of Pediatric Extrapolation

James Travis, PhD

FDA, United States

Lead Mathematical Statistician, OB, OTS, CDER

Andrew  Thomson, PhD, MA, MS

Speaker

Andrew Thomson, PhD, MA, MS

European Medicines Agency, Netherlands

Statistician, Methodology Taskforce

Mark  Rothmann, PhD

Panelist

Mark Rothmann, PhD

FDA, United States

Division Director

Yeruk (Lily)  Mulugeta, PharmD

Panelist

Yeruk (Lily) Mulugeta, PharmD

FDA , United States

Associate Director, Division of Pediatric and Maternal Health, CDER

Sabine  Fuerst Recktenwald, DrMed, MD

Panelist

Sabine Fuerst Recktenwald, DrMed, MD

F.HOFFMANN LA ROCHE LTD, Switzerland

Principal Medical Director PHC Safety Interface Team

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