Regulatory strategies for EU orphan drug development: Roundtable

By Rachel Smith, Therapeutic Area Lead, Rare Diseases
Sinan Sarac, M.D., Ph.D., M.Sc. , Senior Vice President, Head of Oncology Europe, Regulatory Consulting
Simona Stankeviciute, M.D., M.Sc., Vice President, Technical

Published on: May 1, 2025

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