Building Regulatory Capacity

 

FDA’s Office of International Programs (OIP) coordinates and facilitates the Agency’s Capacity Building Program which includes technical cooperation and assistance efforts. CBER partners with OIP in many of those activities, but also leads the effort in regulatory capacity building for regulated products specific to CBER.

 

In 2008, CBER instituted a recurring Foreign Regulators Seminar offered to foreign regulators in response to a steadily increasing demand for information and training in CBER’s regulation of biologics. The CBER Seminar allows CBER staff the opportunity to provide information about the US biologics regulatory processes in an efficient, organized and integrated manner. The program allows CBER experts to explain the regulatory role of CBER, as well as the science, technology, regulations and processes used to do our work. The CBER program offers many advantages to traditional visits such as providing our foreign regulatory counterparts with the opportunity to hear from a broader array of CBER experts, and providing an opportunity for CBER staff and their foreign counterparts to meet and discuss topics of mutual interest. In addition to this face-to-face training opportunity, CBER is currently constructing a web-based program to be offered in 2010. The in-person training will be deferred in 2010 while the web-based program is being built.

 

Additionally, CBER works closely with its multilateral partners, notably PAHO and WHO, to provide assistance in regulatory capacity building. CBER has been very active in supporting the WHO’s Developing Countries’ Vaccine Regulators Network (DCVRN) and the WHO’s African Regional Office-led African Vaccine Regulatory Forum (AVAREF).