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How To Stimulate Orphan Drug Innovation In Europe Under The New Legislative Framework
Session Chair(s)
Victor Maertens
Government Affairs Director at EUCOPE
EUCOPE, Belgium
The EU Pharma Package is a key opportunity to build on the successes of the OMP Regulation. The EU Pharma Package is a key opportunity to build on the successes of the OMP Regulation. This session will inform participants about the new orphan framework, discuss how small and mid-sized companies can respond to the new EU environment for orphan development, create an understanding of implications under the new EU regulatory framework and identify key areas to focus on to unleash innovation and foster R&D within the orphan drug space.
Learning Objective : Inform about the new orphan framework: Discuss how small and mid-sized companies can respond to the new EU environment for orphan development; understand implications under the new EU regulatory framework; identify key areas to focus on to unleash innovation and foster R&D within the orphan drug space; describe the importance to boost private-public partnerships within the rare disease ecosystem.
Speaker(s)
Orphan Medicinal Products in the Context of the EU Pharmaceutical Review: Where Are We Now and Where Are We Going?
Marie Manley
Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
Integrating the Patient Voice: Promoting Innovation for PLWRD
Virginie Hivert, PharmD, PhD
Eurordis-Rare Diseases Europe, France
Therapeutic Development Director
Reflections from an Industry Policy Perspective
Matthias Heck
AstraZeneca Rare Disease, Alexion Pharmaceuticals, Belgium
Head of EU Government Affairs & Strategic Alliance Development, Alexion
Industry Reflections on the Regulatory Ecosystem for Small Orphan Developers
Mariska Mulder, PharmD
Ultragenyx Netherlands BV, Netherlands
Head of Regulatory Affairs, EMEA, LATAM & Marketed Products
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