Twin Cities Chapter: Regulation of Cellular Therapy

Student: $35
RAPS Member: $45
Nonmember: $60

*Fax/email in a completed registration form  to get the student rate.

The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy and human gene therapy products as well as certain devices related to cell and gene therapy. Cellular therapy products include cellular immunotherapies, cancer vaccines and other types of both autologous and allogeneic cells for certain therapeutic indications. The Agency offers several guidances on cellular and gene therapy, but has approved only a limited number of gene therapy products for sale in the United States.

The RAPS Twin Cities chapter invites you to join others from your local regulatory community to hear an interactive presentation on this important topic. Key presentation topics will include:

• A brief overview of the history of FDA regulation of cellular therapy products used for transplant
• A practical look at the world of stem cell transplantation
• How the tissue and drug regulations apply to transplant.
• Introduction to recent advances in the field of cell and gene therapy

This program is brought to you by the RAPS Twin Cities Chapter and is intended to promote knowledge sharing and engagement with others in the in your region. Dinner will be provided and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Ann Kemp, RAC, CQA, principal regulatory and quality consultant, Fang Consulting, Ltd