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Regulatory Challenges for Orphan Medicines
Session Chair(s)
Martine Zimmermann, PHARMD
Senior Vice President, Head of Global Regulatory Affairs, 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)
Emer Cooke, MBA
Executive Director, European Medicines Agency, Netherlands
Regulatory Challenges for Orphan Medicines
Martine Zimmermann, PHARMD
Senior Vice President, Head of Global Regulatory Affairs, Ipsen , France
Regulatory Challenges and Opportunities for Global Development of Orphan Medicinal Products: The Industry Perspective
Vann Parker, PHD
Principal Consultant, PAREXEL International, United States
The Role of Orphan Drug Legislation in Emerging Markets
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