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FDA Proposed Rule 2010: Sponsor Requirements to Report Fraud December 2010

Dec 3, 2010
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Course Description 

This course will present the content and discuss the impact of the new FDA draft regulatory amendment to 21CFR312.56 & 21CFR812.46 regarding the sponsor responsibility for review of ongoing investigations and monitoring investigations, respectively. The seminar will present events leading up to the draft, and include a discussion of what reporting a suspicion of fraud vs. a confirmed case of fraud means, as well as discussion of what is not in the rule that was anticipated.



Learning Objectives 

  • Recognize the history of the draft regulation and events leading to the release
  • Review the content of the draft related to 21CFR312 & 21CFR812
  • Examine implications on stakeholder activities

Who Should Attend 

  • Sponsors/CROs
  • Project Management
  • Medical Writing
  • Regulatory
  • QA
  • Data Management


Sandra ”SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.

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Course Length Time 

1.5 hours 2:30 – 4:00 p.m. Eastern

Course Dates 

December 3, 2010