Welcome to OTP Learn (Office of Office of Therapeutic Products; previously OTAT Learn), the Center for Biologics, Evaluation and Research's (CBER) web page for industry education. CBER ensures the safety, purity, potency, and effectiveness of biological products, including vaccines and allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injuries.  OTP-regulated products include gene therapy, tumor vaccines, xenotransplantation, stem cells, human tissue for transplantation, combination products, bioengineered tissues and certain medical devices.

The presenters are OTP staff and therefore, as employees, have claimed no interests, financial or otherwise, with products that may be shown in any of the presentations.

REdI Biologics Track 2021
Presenters in the biologics track discuss the following topics: Expedited Programs, Regenerative Medicine, Genetically Modified Cells, CMC for In Vivo Gene Therapy Products, Preclinical Development for Gene Therapies, Genetically Modified Cellular and Cancer

OTP Learn Course List:

Listed below are the courses OTP currently offers. Additional online courses may be developed and will be posted upon completion.

You may submit suggestions for future courses to OCTGTLearn@fda.hhs.gov.

Course List

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