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. , Senior Vice President, Head, Regulatory Strategy Europe
Simona Stankeviciute, M.D., M.Sc., Vice President, Technical

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