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Session Chair(s)
Martine Zimmermann, PHARMD
Senior Vice President, Head of Global Regulatory Affairs
Ipsen , France
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
European Medicines Agency, Netherlands
Chair, ICMRA; Executive Director
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
The Role of Orphan Drug Legislation in Emerging Markets
Vann Parker, PHD
PAREXEL International, United States
Principal Consultant
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