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Regulatory strategies for EU orphan drug development: Roundtable

By Rachel Smith, Executive Director, Rare Disease, Center of Excellence
Peter Kiely, M.D., Vice President, Technical
Sinan Sarac, M.D., Ph.D., M.Sc. , Vice President, Technical - Regulatory Strategy
Simona Stankeviciute, M.D., M.Sc., Principal Consultant, Regulatory Strategy

42 min

Parexel experts and former senior EU regulators share the regulatory challenges sponsors must understand to navigate the EU's orphan drug designation process and gain authorization.

Contributing Experts

Rachel Smith

Executive Director, Rare Disease, Center of Excellence

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Peter Kiely, M.D.

Vice President, Technical

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Simona Stankeviciute, M.D., MSc

Principal Consultant, Regulatory Strategy

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Sinan Sirac, MD, Ph.D., MSc 

VP, Technical - Regulatory Strategy

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