Back to Agenda
Unmet Medical Need
Session Chair(s)
Geneviève Le Visage, PharmD, MSc
Head EU RA Policy and Liaison
Novartis Pharma AG, Switzerland
The concept of unmet medical need is very important to many stakeholders. Defining unmet needs is of particular interest when it comes to children, as the Paediatric Regulation foresees an inventory of therapeutic needs as a way of encouraging research in areas where the needs are the greatest. The topic of unmet need is in fact one of the key points in the 2018 EMA/EC action plan on paediatrics. Taking into account that the Regulation imposes obligations onto developers, the question of unmet need is important, especially when many companies are developing in the same disease area. In this panel discussion, using case studies, representatives from the Paediatric Committee, EMA, patients, academia and industry will discuss the specificities of unmet need in paediatric, and how a better identification of paediatric needs can stimulate the development of medicines for children.
Learning Objective : Understand how the Paediatric Regulation operates Understand how the Paediatric Regulation seeks to define paediatric needs Hear the view of a panel of stakeholders on how they understand paediatric needs
Speaker(s)
Panelist
Fabio D’Atri
Unit B5 Directorate General for Health and Food Safey, European Commission , Belgium
Policy Officer, Deputy Head of Unit
Panelist
Dimitrios Athanasiou, MBA
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece
Patient Advocate
Panelist
Jonathan Grigg
Queen Mary’s University Hospital in London, United Kingdom
Professor of Paediatric Respiratory and Environmental Medicine
Panelist
Karl-Heinz Huemer, MD, PhD
Austrian Medicines and Medical Devices Agency (AGES), Austria
Clinical Assessor, Scientific Office
Panelist
Jordi Llinares Garcia, MS
European Medicines Agency, Netherlands
Head of Research and Innovation
Have an account?