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
- Sponsors/CRO: Project Management, Medical Writing, Regulatory, QA, Data Management
Sandra ”SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
Click here for complete trainer biographies
1.5 hours 2:30 – 4:00 p.m. Eastern
August 30, 2010
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-10-028-L01-P. Released: 8/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.