Course Description______________________________
This course presents content and impact discussion of the FDA approved regulation requiring IRB registration with the agency prior to review and approval of research activities. The approved regulation was originally proposed in 2004 and now has been amended and released. The content impacts compliance of sponsors, investigators, and IRBs to GCP requirements. The roles and responsibilities of all stakeholders will be discussed, as well as enforcement and compliance dates.
Learning Objectives_____________________________
Present the purpose of the regulation
Compare the changes made to the original proposed regulations with the final rule
Discuss the industry stakeholder GCP Impact: before, during, and after a study
Outline the roles and responsibilities of IRBs, sponsors, and investigators post approved rule
Present the new regulation compliance dates
Who Should Attend ______________________________
Instructor ______________________________________
Sandra ”SAM” Sather, MS, BSN, CCRA, CCRC
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Course Length and Time__________________________
1.5 hours 12:30 – 2:00 p.m. Eastern
Course Dates ___________________________________
February 12, 2010
Fee____________________________________________
$595
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.
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Accreditation__________________________________
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#: 778-000-09-002-L04-P. Released: 03/09.