Regenerative medicines—gene, cell, and tissue therapies—are widely seen as the future of pharmaceuticals. Yet the greater biological complexity of these products has led to new regulatory challenges. Legislators and regulators have developed new policies and procedures to help facilitate the review, approval, and reimbursement of these medicines, including the Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S. They have also interpreted how existing laws, such as the regulations that govern orphan products, apply to these new technologies. But many challenges remain—including the threat of increased enforcement—and this area continues to hold special interest for life sciences companies.
Please join Covington’s Life Sciences lawyers for our first session of the Regenerative Medicine Webinar Series to discuss the regulation of the products in the U.S., Europe, and China.
Our first session will include a discussion of:
Future session topics will include:
To register, please submit your request via this link.