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U.S. Department of Health and Human Services

Drugs

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CDER Forum for International Drug Regulatory Authorities


Introduction

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 College Park, Maryland.
 

Next Forum    

CDER Forum for International Drug Regulatory Authorities
September 8-12, 2014
College Park, Maryland


Registration for Next Forum

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

If requesting registration, please include the following information about the proposed attendee:

  • name
  • position
  • title
  • agency
  • contact information (e-mail, phone, and mailing address)
      

Previous Forums

CDER Forum for International Drug Regulatory Authorities
       June 17-21, 2013
       College Park, Maryland
 

CDER Forum for International Drug Regulatory Authorities
       November 5-9, 2012
       College Park, Maryland


CDER Forum for International Drug Regulatory Authorities

       April 16-21, 2012
       College Park, 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