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Aligning Stakeholders to Facilitate Access to Medicines for Children: From Product Development Through HTA Review
Session Chair(s)
Barbara E Bierer, MD
Faculty Director, MRCT Center; Professor of Medicine
Harvard Medical School, United States
A diverse group of stakeholders (industry, academics, NRAs, HTAs, patients) met to better understand each group’s evidentiary needs and methodologies to improve communication and to facilitate more equitable access to medicines for children.
Learning Objective : 1. Describe the differences between the data required by regulatory agencies and HTA agencies to make decisions in their spheres 2. Outline how differing archetypes of medicines development impact what data is available for an HTA 3. Discuss three specific challenges to conducting HTA for pediatric indications and proposals to address these challenges.
Speaker(s)
Panelist
Sneha Dave
Generation Patient, United States
Executive Director
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
Siri Wang
Norwegian Medical Products Agency, Norway
Scientific Director; PDCO delegate
Dominik Karres
European Medecines Agency, Netherlands
Scientific Officer
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