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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Building Regulatory Capacity

 

CBER’s International Program leads the effort in regulatory capacity building for regulated products specific to CBER, and is involved in information-sharing and training efforts focused on capacity building priorities.  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. 

Additionally, CBER works closely with its multilateral partners, notably WHO and PAHO, 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).  Continued work in the area of pharmacovigilance supported an FDA CBER course in collaboration with the WHO Uppsala Monitoring Centre (UMC), “Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines” held in Uppsala, Sweden. And currently CBER has initiated two Cooperative Agreements with WHO to further capacity building efforts globally. 

CBER is involved with APEC Life Sciences Innovation Forum (LSIF), Regional Harmonization Steering Committee (RHSC) and its efforts to maximize collaborative and synergistic activities of global economies toward capacity building initiatives. Currently, CBER contributes to expert working groups in the areas of cell therapy product convergence, exploration and exchange of ideas on gene therapies, promotion of good clinical practice inspections, regulatory consistency and quality of scientific reviews for medical products, and promotion of medical product integrity and supply chain security.

Recently, CBER initiated a premiere global vaccine pharmacovigilance initiative, GRUVSS (Global Regulatory Utilization of Vaccine Safety Surveillance).  The initiative addresses the need for improved global vaccine safety monitoring, collaboration with national and international entities toward this effort, and regulatory strengthening (capacity building) activities and training to support this need.

In 2008, CBER initiated the 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 allowed CBER staff the opportunity to provide information about the US biologics regulatory processes in an efficient, organized and integrated manner. The program allowed CBER experts to explain the regulatory role of CBER, as well as the science, technology, regulations and processes used to do our work.

CBER’s International Program seminars offer 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 provides an opportunity for CBER staff and their foreign counterparts to meet and discuss topics of mutual interest. 

In 2011, CBER constructed a web-based program which offers the same introduction to the US biologics regulatory processes, with the convenience of online training.  Future face-to-face training opportunities will now be more focused in emerging areas of high priority and varied interests to the global regulator.

 
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