FALLS CHURCH, Va., March 14, 2019 /PRNewswire-PRWeb/ -- Cell & Gene Therapy Strategies for Successful BLA Submissions
The FDA predicts that by 2025 it will be approving 10 to 20 cell and gene therapy products a year.
That will only come true if sponsors are ready for the unique challenges of BLAs for cell and gene therapy products.
Scott R. Burger, MD — Principal, Advanced Cell and Gene Therapy — will discuss the FDA's requirements for successful BLAs and how to comply and make you aware of the common mistakes and how to avoid them. He'll help attendees understand:
It's time to get prepared for the unique challenges of BLAs for cell and gene therapy products.
Meet Your Presenter: Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 120 companies in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and CMC regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cell, NK, and DC immunotherapies, gene-edited cell therapy products, as well as stem cell- and somatic cell-based regenerative medicine products.
Who Will Benefit
Webinar Details: Biosimilars Regulation Latest Regulatory, Compliance & Approval Developments **An FDAnews Webinar** Thursday, Feb. 14, 2019, 1:30 p.m. - 3:00 p.m.EST http://www.fdanews.com/blasubmissions
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/blasubmissions By phone: 888-838-5578 or 703-538-7600
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