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Field Investigators are frontline protectors of public health and safety. To effectively carry out their jobs, they are required to know the relevant regulations that bind the firms they investigate.

The audio-visual self-learning modules developed in 2000 and available on this web site offer a comprehensive review of these FDA regulations.  The content of this course continues to be correct.  However, organizational changes have occurred and are reflected in the note below.

With this knowledge, the Field Investigator will be able to facilitate the critical responsibility of collecting and documenting information associated with the adverse effects of drugs. No credit is offered for this course. (This video will be updated when new ADE regulations go into effect).

Streaming Video (September 2000)

RealPlayer:
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28kbps (dial-up modem)
- 150kbps (network speed)

WindowsMedia:
- 28kbps (dial-up modem)
- 150kbps (network speed)

Watching the video may require installation of RealPlayer or WindowsMedia Player software.

Download the RealPlayer, Free

Download the Windows Media Player, Free

Video Slides  [HTML] or [PPT]

Video Transcript

Handbook to the Audio-visual Self-learning Modules

The FDA's Post-marketing Adverse Drug Experience Inspectional Program (Slides) [HTML] or [PPT]


Note Organizational Changes: Dr. Steven Galson, M.D., is acting CDER director.

The Office of Post-Marketing Drug Risk Assessment (OPDRA) has been renamed the Office of Drug Safety (ODS) and the Office Director is Paul Seligman M.D.

Also, the division within CDER's Office of Compliance responsible for all post-marketing surveillance activities has been renamed the Division of Compliance Risk Management and Surveillance and the Acting Director is Kathy Miracco.

Current CDER Organization Chart


Date created:10/28/2004

 
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