WEBINAR: Navigating Orphan Medicines Regulation: Strategic Insights from the US and Europe – March 17th, 10:00 to 11:00 ET

As regulatory frameworks for orphan medicinal products continue to evolve on both sides of the Atlantic, understanding the practical and strategic implications is increasingly important. On March 17th from 10:00 to 11:00 ET, Pinsent Masons and Hyman, Phelps & McNamara, P.C. are pleased to host a joint webinar.  Catherine Drew, Partner, Pinsent Masons and Sara W. Koblitz, Director, Hyman, Phelps & McNamara will share insights into current trends and emerging issues in orphan medicines regulation and compliance.

During the session, our speakers will provide practical insights into the orphan medicines regulatory landscape, including:

• A comparison of criteria for designation as an orphan medicinal product in the US & Europe;
• The benefits of orphan designation; a consideration of exclusivity rewards for such products and comparison to exclusivity rights granted to NCEs or NBEs;
• An overview of upcoming changes to the orphan regime as part of reform of EU pharmaceutical legislation.

This session is designed for regulatory affairs professionals, in-house counsel, compliance teams, and others with an interest in medicines regulation.

We hope you can join us for what promises to be an informative and engaging discussion.

Registration Link: 2026-03-17 – Webinar – Navigating Orphan Medicines Regulation: Strategic Insights from the US and Europe | Hyman Phelps registration.