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Orphan and Paediatric Medicines – Future Direction and Regulatory Landscape
Session Chair(s)
Peter W.L. Bogaert, MA
Partner
Covington & Burling LLP, Belgium
The EU orphan and paediatric regimes aim at addressing specific patient and public health needs. They form part of the scope of the current incentives review. What are the dynamics of the systems, what lessons can be learnt, what way to go forward?
Learning Objective : Understanding the interpretation of the EU orphan medicines rules. Linking this to the policy and public health objectives of the regime.
Speaker(s)
The Current Legal Interpretation of the EU Orphan Medicines Regime by the EU Courts
Peter W.L. Bogaert, MA
Covington & Burling LLP, Belgium
Partner
Pediatric Orphan Medicines Development in Rare Diseases
Dinah Duarte, MSC
European Medicines Agency, Netherlands
Signal Management Lead
Patient Perspective
Dimitrios Athanasiou, MBA
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece
Patient Advocate
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