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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)
Sneha Dave
Executive Director , Generation Patient, United States
Panelist
Christina Bucci-Rechtweg, MD
Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Siri Wang
Scientific Director; PDCO delegate, Norwegian Medical Products Agency, Norway
Dominik Karres
Scientific Officer, European Medecines Agency, Netherlands
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