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Wednesday, February 6 • 12:00 - 13:15
#S0102: Optimising Paediatric Drug Development in the EU

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Component Type: Session

This session is a follow-up to Session 0101 - Optimising Orphan Drug Development in the EU. Different stakeholders will be brought together to discuss how they can contribute to better and more efficient paediatric drug development in Europe. From the current regulatory framework to ways drug developers approach such R&D, speakers will provide different perspectives on the experience so far and how Europe can be an important region to bring innovative treatments to children. A follow-up panel will include paediatric and orphan perspectives from both sessions. efficient paediatric drug development in Europe. From the current regulatory framework to ways drug developers approach such R&D, speakers will provide different perspectives on the experience so far and how Europe can be an important region to bring innovative treatments to children. A follow-up panel will include paediatric and orphan perspectives from both sessions.

Chair

Karl-Heinz Huemer, MD, PhD

Speaker

Panel Discussion
Geneviève Le Visage, PharmD, MSc

Panel Discussion
Camilla Nawrocki, MPharm

Panel Discussion
Dimitrios Athanasiou, MBA

Panel Discussion
Sandra L. Kweder, MD


Speakers
avatar for Dimitrios Athanasiou

Dimitrios Athanasiou

Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS
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 →
KH

Karl-Heinz Huemer

Clinical Assessor, Scientific Office, Austrian Medicines and Medical Devices Agency (AGES)
PhD (in biology) and MD University of Vienna research at Medical University of Vienna (main area neuroscience) since 2007 assessor at the Austrian Medicines Agency full member in EMA - Paediatric Committee (PDCO) alternate member in EMA - CHMP Scientific Advice Working Party (SAW... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Camilla Nawrocki

Camilla Nawrocki

Senior Regulatory Project Manager, Zealand Pharma A/S
Camilla Nawrocki has a MScPharm and a Master in Industrial Drug Development from University of Copenhagen and more than 15 years of pharma industry experience from Novo Nordisk, Lundbeck and Shire with solid knowledge about the entire product life cycle and value chain. Camilla has... Read More →
avatar for Geneviève Le Visage

Geneviève Le Visage

Regional Head RA Europe Policy & Liaison, Novartis Pharma AG
Pharmacist by training, with a masters in Science Communication Currently heads the team responsible for regulatory intelligence and policy for the EU for Novartis in Basel, Switzerland, supporting project teams in establishing their strategy for filing in the EU, including for paediatrics... Read More →

Wednesday February 6, 2019 12:00 - 13:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  01 Stakeholders and Regulatory System Optimisation, Session
  • Featured Topics Regulatory Science
  • Tags Session