Drugs
Resources for You
CDER Forum for International Drug Regulatory Authorities
Over the years, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has been privileged to host many of our international colleagues interested in learning about our drug review process. The CDER forum was established for the exchange of drug regulatory information between the U.S. FDA CDER and its counterpart agencies in other countries. The training is not open to the pharmaceutical industry or non-regulatory authorities. The training is not intended for U.S. government employees.
CDER desires to continue to be responsive to requests from our international colleagues.
The CDER Forum for International Drug Regulatory Authorities provides information about the U.S. drug regulatory processes in an organized and integrated manner. It will explain the role of CDER as well as the science, technology, regulations and processes used to do our work.
There is no registration fee for this program. However, attendees are responsible for their own travel expenses. The program will be offered in Silver Spring, Maryland.
|
CDER Forum for International Drug Regulatory Authorities
October 5 - 9, 2009 Silver Spring, Maryland Meeting and Registration Information |
Participation in the CDER Forum for International Drug Regulatory Authorities is only open to Drug Regulatory Authorities. Confirmation of registration and additional meeting information will be sent to approved participants.
Requests for registration and information about registration should be sent to CDERForum@fda.hhs.gov.
Part of the registration process is acquiring security clearance. Since the security clearance is building-specific, you will be cleared only for attendance at the CDER Forum. Please complete the security form and send it, along with your registration request, to CDERForum@fda.hhs.gov.
If requesting registration, please include the following information about the proposed attendee:
- • name
- • position
- • title
• agency - • contact information (E-mail, phone, and mailing address)
• completed security form
- CDER Forum for International Drug Regulatory Authorities
- April 20 - 24, 2009
Silver Spring, Maryland
- CDER Forum for International Drug Regulatory Authorities
- October 6 - 10, 2008
Rockville, Maryland
CDER Forum for International Drug Regulatory Authorities- April 14 - 18, 2008
Rockville, Maryland
- CDER Forum for International Drug Regulatory Authorities
- October 1 - 5, 2007
Rockville, Maryland
- CDER Forum for International Drug Regulatory Authorities
- April 16 - 20, 2007
Rockville, Maryland
- CDER Forum for International Drug Regulatory Authorities
- September 25 - 28, 2006
Rockville, Maryland
More information about CDER can be found on the Drugs section of the FDA website.
The following learning modules can be accessed online at CDERLearn:
- Drug Review and Related Activities in the United States
- Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)
- The FDA Process for Approving Generic Drugs
For further information, contact:
Justina A. Molzon, MS Pharm, JD
Associate Director for International Programs
Center for Drug Evaluation and Research
United States Food and Drug Administration
U.S. Department of Health and Human Services
CDERForum@fda.hhs.gov