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Regenerative Medicine Webinar Series: Introduction to the Regulation of Gene, Cell, and Tissue Therapies in the U.S., Europe, and China


April 22, 2021

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:

  • Background on gene, cell, and tissue therapies and their regulation in the U.S., Europe, and China
  • Preview of the special development issues for gene therapies, including CMC and clinical challenges
  • Preview of U.S. expedited programs, e.g., RMAT and Accelerated Approval
  • Preview of regulatory exclusivities in the U.S. and Europe, including for Orphan Products
  • Preview of regenerative medicine regulatory issues in China

Future session topics will include:

  • Session 2: U.S. FDA and European Regulation of Gene, Cell, and Tissue Therapies
  • Session 3: U.S. and European Regulatory Exclusivities and IP Protection for Regenerative Medicines
  • Session 4: China: Regulation of Regenerative Medicine
  • Session 5: Gene, Cell, and Tissue Therapies: Complex Life Sciences Transactions, Privacy, and Data Security
  • Session 6: Market Access and Reimbursement Roundtable for Regenerative Medicine

To register, please submit your request via this link.