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. CBER partners with a range of organizations in undertaking these efforts. CBER’s relationship to the World Health Organization (WHO) and the Pan American Health Organization (PAHO) is a cornerstone to these efforts as evidenced by CBER’s status as a PAHO/WHO Collaborating Center for Biological Standardization. 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 Senior Advisor for International Affairs (SAIA) and staff on an International Team within the Office of the Director. The SAIA 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.
- Joan Wilmarth Blair, M.A., Senior Advisor for International Affairs
- Gopa Raychaudhuri, Ph.D., Senior Scientist, CBER Liaison to WHO
- David Cho, Ph.D., M.PH., Senior Scientist for Pandemic Threat Preparedness and Global Inspectional Collaborations
- Judith Badoo, M.S., Foreign Regulatory Communications Coordinator
- Leslie Haynes, RD, Foreign Regulatory Capacity Building Coordinator