GCP E6 R2 provides significant detail on implementing a system of quality
management with a focus on a risk-based/risk management approach for the trial,
also referred to as Risk-Based Quality Management. This web seminar reviews
this new sponsor requirement and describes the clinical quality management
system (cQMS) that should be used to oversee quality during the design,
conduct, recording, evaluation, reporting and archiving phases – notably the
lifecycle of the clinical trial. Additionally, cQMS industry benchmarks,
standards and practices will also be discussed.
- Describe two new requirements for the sponsor’s
quality management (QM) of clinical trials
- Identify two approaches to achieve
compliance with QM for the clinical trial lifecycle
- Determine next steps for evaluation
and implementation of the new requirements
- Trial Managers
- Project Managers/Directors
- Clinical Quality
Mills, R.N., C.C.R.A.
Click here for complete trainer
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 2 hours (0.2 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#: 0778-0000-17-076-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1