Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance

Upcoming Courses
Course #: BI13651
October 22, 2019
9:30 AM - 11:00 AM Eastern
$735.00
Course #: BI13745
January 16, 2020
2:00 PM - 3:30 PM Eastern
$735.00

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

  • 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

Who Should Attend

  • Sponsor, CRO, or Clinical Investigator/Sponsor-Investigators Responsible Parties
  • Regulatory Affairs Professionals
  • Project Managers/Directors
  • Clinical Quality Assurance/Compliance Personnel
  • Clinical Operations Professionals

Instructor

Elizabeth Ronk Nelson, MPH

Click here for complete trainer biographies

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.

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#: 0778-0000-19-024-L01-P. Released: 3/19.   

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.