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.
- 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
- Project Management
- Medical Writing
- Data Management
Sandra ”SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
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1.5 hours 2:30 – 4:00 p.m. Eastern
December 3, 2010