The objectives of this webinar (45-minute presentation / 15-minute Q&A) are to provide insight into how to adapt trial oversight activities using risk based principles, discuss key factors that drive decision making around monitoring strategies and learn about practical examples in the time of COVID-19.
Background
Since publication of the ICH-GCP R2 addendum, risk-based trial approaches have steadily made their way into the clinical drug development industry. The dynamic nature of risk based monitoring (RBM) with its focus on the most critical areas, makes it a uniquely important asset for tackling today’s trial challenges in COVID times.
Join our webinar and discover how applying RBM principles can help you to successfully adapt trial oversight activities to the changing environment and prepare for the future.
Agenda
-
Background of risk based monitoring (RBM)
- Regulatory framework: before and after COVID-19
- Key principles
-
Monitoring approaches and considerations
- How to effectively adjust monitoring plans
- Centralized monitoring
- Remote vs onsite monitoring
- Guidance and preventive measures for teams
-
Practical insights for revising risk management strategies
- Recommendations for (re-)assessing risks
- Documenting and tracking the impact
- Real life examples
-
Q&A
Presenters
Joanne Zephirin – US Clinical Research Associate Manager, SGS
Steven Thys – Director Global Clinical Operations, SGS
Target Audience
Project managers, quality assurance managers, clinical research coordinators and anyone involved with clinical operations
Date: Thursday, July 02, 2020
Time: 04:00 PM Central European Summer Time
Language: English
Cost: No Charge