The
updated ICH GCP E6 R2 is more descriptive than the previous version and
describes 26 items of change. These changes consist of new items in definitions;
new sections on investigator responsibilities, including oversight; a
substantial new sponsor section on quality management, including risk assessment;
monitoring plans defined and implemented; introducing Risk-Based Quality
Management; serious breaches, and, a new section on computer validation and
electronic records, to name a few. This web seminar explores the changes in
detail to promote a better understanding of how they impact clinical trials.
Practical information and a systematic approach in assessing organizational
SOPs, processes and practices as well as designing modifications to assist with
implementation will also be provided.
- Identify the changes impacting investigator
responsibilities and roles
- Explain the impact of the revisions
to sites and Sponsors-Investigators
- Evaluate solutions for applicability/modification
of organizational SOPs, processes, procedures and staff training
- Apply lessons learned for effective
implementation of the new ICH GCP E6 R2 guideline
- Quality Assurance/Compliance Personnel
- Principal
Investigators/Sub-Investigators
- Research Site Staff (Managers, CRCs,
Data Managers/Data Entry)
- Managers/Directors: Clinical
Operations, Clinical Research, Data Management, Quality Management,
Compliance, Process Improvement, Risk Management, Quality Risk Management
- Study Managers/Project Managers,
CRAs/Monitors (Centralized, On-site)
Mary
Mills, R.N., C.C.R.A.
Click here for complete trainer
biographies
$835
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#: 0778-0000-17-075-L01-P.
Released: 1/17.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.