Course Description
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that responsible parties for applicable clinical trials register with, and submit the results information to, the ClinicalTrials.gov data bank. The FDA has been given compliance/enforcement responsibilities related to the failure to submit required clinical trial information under 42 CFR Part 11. This web seminar will discuss the FDA’s processes for assessing compliance of, and implementing civil monetary penalties against, those responsible parties who fail to meet these regulatory obligations.
Learning Objectives
Who Should Attend
Instructor
Elizabeth Ronk Nelson, MPH
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Registration Fees
$735
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, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com
Accreditation Information
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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-21-029-L04-P. Released: 3/21.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.