The Center for Biologics Evaluation and Research (CBER) regulates biological products, including blood and blood products, blood derivatives, vaccines, allergenics, gene therapies, cellular therapies, and xenotransplantation, certain drug products, HIV test kits, medical devices involving blood and human cells and tissue products.
CBER is comprised of the Office of the Director and seven program offices. Three of the program offices are responsible for regulatory oversight of biological products—vaccines and allergenics; blood and blood products; and tissues and advanced therapies. The four remaining offices provide cross-cutting support in the areas of compliance; surveillance, epidemiology and biostatistics; communication, outreach and development; and management, budget and administrative services. The Office of the Director provides leadership and policy direction to the program offices and coordinates Center activities and resource management.
Meet Peter Marks MD, PhD, Center Director
Info on Vaccines, Blood & Biologics
August 13, 2024 10:00Speakers:
Deirdre Hussey
Office of Management
August 13, 2024 10:02Speakers:
Peter Marks, M.D., Ph.D.
Office of the Director
August 13, 2024 10:05Speaker: John Swann, Ph.D.
Office of the Commissioner
August 13, 2024 10:30Speaker: Irene Carroll
Office of Communication, Outreach and Development (OCOD)
August 13, 2024 10:30
August 13, 2024 11:00Speakers:
Rondine Allen, Ph.D., Senior Biologist
Office of Therapeutic Products (OTP)
CDR Rod Barrais, D.H.S.c, Regulatory Officer
Office of Vaccines Research and Review (OVRR)
Cinque Soto, Ph.D., Lead Bioinformatics Reviewer
Office of Therapeutic Products (OTP)
Adam Spanier, M.D., Physician (Team Lead)
Office of Vaccines Research and Review (OVRR)
August 13, 2024 11:50
August 13, 2024 12:00
August 13, 2024 13:00Speaker: Karen Donnelly, M.B.A.
Office of Talent Solutions
August 13, 2024 14:00Speaker: LuDrean Peterson, M.S.M, M.B.A.
Office of Talent Solutions
August 13, 2024 15:00Speaker: Deirdre Hussey
Office of Management