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.
- Assess responsible parties’ regulatory
requirements for registering, certifying, and reporting the results of
applicable clinical trials
- Discuss the FDA’s procedures for
communicating with responsible parties and seeking civil monetary
penalties
- Evaluate the approach for answering
and contesting the FDA’s findings
- Review the triggers and limits of
civil monetary penalties
- Sponsor, CRO, or Clinical
Investigator/Sponsor-Investigators Responsible Parties
- Regulatory Affairs Professionals
- Project Managers/Directors
- Clinical Quality
Assurance/Compliance Personnel
- Clinical Operations Professionals
Elizabeth
Ronk Nelson, MPH
Click here for complete trainer
biographies
$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.
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#: 0778-0000-19-024-L01-P.
Released: 3/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.