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Thursday, February 7 • 09:15 - 10:15
#S0205: Orphan and Paediatric Medicines – Future Direction and Regulatory Landscape

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Component Type: Session

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?


Peter W.L. Bogaert, MA


The Current Legal Interpretation of the EU Orphan Medicines Regime by the EU Courts
Peter W.L. Bogaert, MA

Pediatric Orphan Medicines Development in Rare Diseases
Dinah Duarte, MSc

Patient Perspective
Dimitrios Athanasiou, MBA

avatar for Dimitrios Athanasiou

Dimitrios Athanasiou

Dimitrios Athanasiou is a PDCO member representing EURORDIS. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full time patient advocate in DMD, he is a... Read More →
avatar for Peter Bogaert

Peter Bogaert

Partner, Covington & Burling LLP
A managing partner of the Brussels office of Covington & Burling, with a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. Also represents life sciences... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED, Portugal
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →

Thursday February 7, 2019 09:15 - 10:15 CET
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  02 Evolution of Science and Policy, Session
  • Featured Topics Translational Medicine
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