DIA
Drug Information Association Logo
« Back to Listing

Regulatory Challenges for Orphan Medicines

Track:
Rare/Orphan Diseases

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
399B

Room Number:
32AB

Level:
Intermediate

Type:
Symposium

Title:
Regulatory Challenges for Orphan Medicines

Chair(s):
Martine Zimmermann, PharmD
Vice President, Global Regulatory Affairs
Alexion Pharma International Sàrl, Switzerland

Description:
This symposium will describe the regulatory environment and the current regulatory trends for orphan medicinal products around the world. It will also discuss how companies can use the orphan legislation in Europe and the US to support development of products for markets outside of these ICH regions.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Regulatory Challenges for Orphan Medicines
Emer Cooke, MBA
Head of International Affairs
European Medicines Agency, European Union, United Kingdom

Regulatory Challenges and Opportunities for Global Development of Orphan Medicinal Products: The Industry Perspective
Martine Zimmermann, PharmD
Vice President, Global Regulatory Affairs
Alexion Pharma International Sàrl, Switzerland

The Role of Orphan Drug Legislation in Emerging Markets
Vann Parker, PhD
Principal Consultant
PAREXEL International, United States