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A critical component in how CBER carries out its regulatory responsibilities is through its international engagements. Many of the products CBER regulates directly address infectious disease threats which are not isolated to the U.S. CBER is also cognizant of the growing globalization of the discovery, development, production and distribution of CBER’s regulated products and the associated need for global engagement.

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research. Regulatory dialogue and cooperation in information sharing with foreign regulatory counterparts under Agency confidentiality arrangements also are strategically important in CBER’s international programs.

The international activities at CBER are managed and coordinated by the Associate Director for International Affairs and staff on an International Team within the Office of the Director. The Associate Director for International Affairs counsels the Center Director on a wide range of strategic international issues critical to CBER and works with the International Team to implement policies related to interactions with international organizations and international regulatory authorities for biologics.

Contact Information:

Gopa Raychaudhuri, PhD
Associate Director for Special Programs
Associate Director for International Affairs (Acting)
Judith Badoo, M.S.
Foreign Regulatory Communications Coordinator
Marijo Kambere, Ph.D., PMP
Health Scientist Administrator