Foreign Regulatory Seminar (Web-Based): CBER’s Regulation of Biologics

CBER’s international activities include meetings and training on the regulation of biologics, which is presented to regulators across the globe. CBER now introduces a web-based program intended to provide information on the work at CBER in the oversight of biological products in the United States.

This outreach program was generated from a live program held in October 2009*. With modest editing, staff developed this web-based production in order to broaden its reach to those who have not been able to participate in past meetings, or will not be able to participate in future live events held by FDA Center for Biologics Evaluation and Research.

For additional benefit to the learning experience, CBER has generated an email address for specific questions, once the entire web-based outreach program is reviewed (as many questions can be answered in a number of the presentations).

Email questions or comments to: ForeignRegOutreach@fda.hhs.gov

CBER appreciates your interest in the U.S. regulation of biologics. Thank you.

* Outreach program is a snapshot in time and will become dated. CBER hopes to refresh the program to keep pace with any changes to policy, regulations or legislation which may occur.

View Web Based Outreach Program Presentations