Vaccines, Blood & Biologics
CBER Foreign Regulators Seminar (Live)
Over recent years, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has been privileged to host the CBER Foreign Regulators Seminar for foreign regulatory counterparts interested in learning about our biologics review process. This live seminar provides information about the U.S. biologics regulatory process, which includes vaccines, blood and blood products, cellular and gene therapies, human tissues, medical devices, biostatistics and epidemiology, compliance and biologics quality, reviewer training guidance and regulations, bioresearch monitoring, licensing and post-marketing activities, and allows many opportunities for networking and question/answer sessions.
CBER continues to be responsive to requests from our international colleagues. CBER is now privileged to offer the resource: Foreign Regulatory Seminar (Web-Based): CBER’s Regulation of Biologics. This web-based outreach program moves the online viewer through the basic regulatory processes within the Center, and answers many questions submitted to CBER from interested parties all over the world. This web-based program is a pre-requisite for attendance at any live CBER Foreign Regulators Seminar in the future.
The live seminar is generally open only to staff from foreign pharmaceutical regulatory (government) authorities at the request of their organizations. The live outreach program is not intended for U.S. government employees. There would be no registration fee for the live program; however, attendees would be responsible for their own travel, lodging and food expenses.
Notice: Future Seminars are under development. Please continue to visit this website for updates.
When a future seminar is announced, if a pharmaceutical regulatory authority is interested in having its staff participate in the outreach seminar, a senior official of the regulatory authority should send information listed below via email to CBERForReg@fda.hhs.gov for each potential participant. As a reminder, the CBER Foreign Regulators Seminar is intended for international pharmaceutical regulatory authorities and only registration from pharmaceutical regulatory authorities will be honored. Please include the following information about the proposed attendee:
- Name of Regulatory Authority
- Intention to complete pre-requisite web training, “Foreign Regulatory Seminar (Web-Based): CBER’s Regulation of Biologics”
During the registration period of a live seminar, an Invitation Letter will be sent back to applicable requesting participants. Registration is confirmed upon receipt of a “Confirmation” letter from the CBER Foreign Regulators Seminar Working Group, to include verification that the proposed attendee has completed the pre-requisite “Regulatory Seminar (Web-Based): CBER’s Regulation of Biologics”. (hyperlink to web program Intro page).
There would be no registration fee for the live seminar; however, attendees would be responsible for their own travel, lodging and food expenses.
A full Agenda will be posted prior to the live seminar date.
Also note the Center for Drug Evaluation and Research (CDER) hosts the CDER Forum for International Drug Regulatory Authorities.
Meeting Information for Previous CBER Foreign Regulator Seminars:
For further information, contact: CBERForReg@fda.hhs.gov