DIA/EFGCP/EMA Conference on How to Optimise Children’s Access to Innovative Medicines

United in the goal of increasing the availability of new medicines to paediatric patients, how can we leverage examples from past successes to overcome future barriers?

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Session 2C Extrapolation - Application of the EMA Extrapolation Framework

Session Chair(s)

Cécile Mathilde Ollivier, MS

Managing Director Europe

Critical Path Institute, Netherlands

Christina Bucci-Rechtweg, MD

Global Head, Maternal Health and Pediatric Regulatory Policy

Novartis , United States

The EMA will release for public consultation an update of the EMA Extrapolation Reflection Paper. The proposed EMA Extrapolation Framework will be presented at the session, followed by a case study. The session is aiming at illustrating and discussing with different stakeholders choices companies may have to face when extrapolation approaches are planned as part of a paediatric development, particularly considering that the selected strategy need to address requirements for the regulatory decision–making.

Speaker(s)

Lynne Yao, MD

FDA, United States

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER

EXTRAPOLATION –APPLICATION OF THE EMA EXTRAPOLATION FRAMEWORK

Daren Austin, PhD

GSK, United Kingdom

Senior Fellow and Senior Director, Clinical Pharmacology

Sabine Derey, PharmD