Back to Agenda
Session 2C Extrapolation - Application of the EMA Extrapolation Framework
Session Chair(s)
Cécile Mathilde Ollivier, MS
VP Global Affairs
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
GSK, United Kingdom
Regulatory Manager, Respiratory Therapeutic Group, Global Regulatory Affairs
Have an account?