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.
- Michelle Limoli, PharmD
Associate Director for International Affairs
- Judith Badoo, M.S.
Foreign Regulatory Communications Coordinator
- Gopa Raychaudhuri, PhD
Senior Scientist, CBER Liaison to PAHO/WHO
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
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