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  1. International Activities

Foreign Regulators – Information and Training Resources

Helping to Build and Strengthen Global Partner Regulatory Systems

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.

Regulatory capacity building efforts employ multiple modalities, some of which take the form of information sharing, championing of initiatives, participation in global engagements and collaborative projects, expert consultation, direct training, hosting foreign counterpart visits, supporting other organizations’ capacity building and outreach activities.

To better assist the regulatory community, CBER has conveniently provided a Quick Guide on FDA’s regulatory information, which consists of links to FDA webpages as a helpful resource.

In 2011, CBER constructed a web-based capacity building training program which offers an introduction to the US biologics regulatory processes, with the convenience of online training. The CBER online outreach training continues to educate and inform regulators across the globe.

CBER has engaged in capacity building efforts in partnership with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), which has included training via an in-country regulatory training workshop format, as well as secondment of foreign regulators within FDA. To assure sustainability of those efforts, CBER is exploring partnering with others, notably the World Health Organization (WHO), to build upon the foundational work already undertaken. For more information on the workshop, please see the PEPFAR Activities within CBER .

Additionally, CBER works closely with its multilateral partners, most notably the WHO. CBER’s engagements with WHO are more fully addressed on separate web pages, however one illustrative effort of CBER’s regulatory capacity building in partnership with the WHO is in the area of pharmacovigilance. CBER has and continues to support an annual course in Uppsala, Sweden, in collaboration with the WHO Uppsala Monitoring Centre (UMC), “Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines.”

The Agency engages in a range of explicit harmonization initiatives, which contribute to regulatory capacity building with training seminars and online webinars. CBER’s expansive work with ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), IPRF (International Pharmaceutical Regulators Forum), and APEC RHSC (Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee) maximizes collaborative and synergistic activities while harmonizing or converging regulatory ideas and needs of the global community.

CBER is a founding member of the ICH Steering Committee and participates in expert working groups for standardization of technical guidelines. As a regulatory body, CBER works within IPRF to share strategies for harmonizing standards, and communicates with other global regulators on priority topics. APEC RHSC plays a primary role in facilitating training mechanisms, and within that effort CBER contributes to expert working groups in priority areas such as cell and gene therapy product convergence, good clinical practice inspections, consistency and quality of scientific reviews for medical products, and promotion of medical product integrity and supply chain security.

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