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Regulatory Challenges for Orphan Medicines
Session Chair(s)
Martine Zimmermann, PharmD
Senior Vice President, Head of Global Regulatory Affairs, R&D Quality
Ipsen , France
Regulatory Challenges and Opportunities for Global Development of Orphan Medicinal Products: The Industry Perspective
Learning Objective : Review the opportunities offered by the different legislations for treatment of rare diseases; Define the regulatory framework and requirements for orphan products in the ICH regions and the emerging markets; Discuss the regulatory aspects that may impact marketing authorization of orphan medicines.
Speaker(s)
Regulatory Challenges for Orphan Medicines
Emer Cooke, MBA, MSc
The European Medicines Agency, Netherlands
Executive Director, Chair, ICMRA
Regulatory Challenges and Opportunities for Global Development of Orphan Medicinal Products: The Industry Perspective
Martine Zimmermann, PharmD
Ipsen , France
Senior Vice President, Head of Global Regulatory Affairs, R&D Quality
The Role of Orphan Drug Legislation in Emerging Markets
Vann Parker, PhD
PAREXEL International, United States
Principal Consultant
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