Web Seminars for Clinical Research Professionals
A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA
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
Instructor
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
Click here for complete trainer biographies
Registration Fees
$735*
*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com 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#: 0778-0000-25-047-L99-P. Released: 8/25.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
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