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.
- 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
- Clinical Investigators and Staff
- Clinical Research Associates
- Study and Clinical Research
Associate Managers
- Sponsors/CROs Clinical Operations
- Clinical Quality Compliance and
Quality Assurance Professionals
Debbie Harper, B.Sc., P.M.P.
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#: 0778-0000-17-036-L01-P.
Released: 3/17.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.