Implications of the FDA Guidance for a Risk-Based Approach to Monitoring and the EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials

Upcoming Courses
Course #: BI14119
November 18, 2020
3:00 PM - 4:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

Course Description

The FDA and EMA describe their expectations for risk-based approaches to quality management and monitoring in the ‘FDA Guidance Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring’ and the ‘EMA Reflection Paper on risk-based quality management in clinical trials,’ both of which are reviewed in this web seminar, which also includes industry think tank contributions. 

Learning Objectives

  • Discuss the FDA Guidance and EMA Reflection Paper for clinical trial risk management and monitoring
  • Evaluate industry think tank trends (TransCelerate, CTTI)
  • Review best practices for risk management for trial oversight and monitoring

Who Should Attend

  • Clinical Investigators and Staff
  • Clinical Research Associates
  • Study and Clinical Research Associate Managers
  • Sponsors/CROs Clinical Operations
  • Clinical Quality Compliance and Quality Assurance Professionals


Marla Hoelle, BSN, RN, CCRA, ACRP-PM, PMP

Click here for complete trainer biographies

Registration Fees


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#: 0778-0000-20-074-L04-P. Released: 11/20. 

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