The U.S. Food and Drug Administration organises training through the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

CDER

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) organizes bi-annually a CDER Forum for International Drug Regulatory Authorities to provide information about the U.S. drug regulatory processes in an organized and integrated manner. It explains the role of CDER as well as the science, technology, regulations and processes used to do our work.

For registration and any further information on CDER send your request to the Center for Drug Evaluation and Research, US FDA, U.S. Department of Health and Human Services.

CDER World

Since 2005, CDER has held the CDER Forum for International Drug Regulatory Authorities every spring and fall so international regulators can learn first-hand how CDER organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the United States. To respond to the growing interest in these meetings, the Center has developed “CDER World.” “CDER World,” is an ever-growing compendium of information about how CDER carries out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science to improve the public health.
CDER will populate these Web pages with information based on the CDER International Forum series. CDER World will expand as modules are developed, designed and posted on the Web.

For more information, see the FDA website: CDER World

Mailing Adress:
FDA, CDER, Department of Health and Human Services, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002
Email: CDERForum@fda.hhs.gov
Website: www.fda.gov/Drugs/

CBER

The U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) organizes, on a periodic basis, a CBER Foreign Regulators Seminar to provide 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.

For registration and any further information about registration send your request to the Center for Biologics Evaluation and Research, US FDA, U.S. Department of Health and Human Services.

Web-Based Outreach Program

FDA CBER's 2011 Strategic Plan includes the goal of improving global public health through international collaboration, including promoting research and information sharing. In working to achieve this goal, CBER is introducing a web-based Outreach program intended to provide information to foreign regulatory counterparts on CBER's oversight of biological products in the United States. The program was generated from a live seminar held in 2009 directed to a group of foreign regulators, and hence the program is a snapshot in time of CBER's responsibilities. This web-based program may be refreshed in the future with changes to policy, regulations or legislation. CBER's desire is to broaden the reach of this important information to foreign counterparts who have not been able to participate in the "live" programs offered in the past, as it reflects FDA's shared goal of enhancing regulatory capacity and regulatory convergence in the interest of global public health.

For more information, see the FDA website: CBER web-based outreach program

Mailing Adress:
FDA, CBER, Department of Health and Human Services, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002
Email: CBERForReg@fda.hhs.gov
Website: www.fda.gov/BiologicsBloodVaccines/