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 implemented during the COVID-19 pandemic.
AGENDA
- Background of Risk Based Monitoring (RBM)
- Regulatory framework: before and after COVID-19
- Key principles
- Monitoring approaches & 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 & tracking the impact
- Real life examples
- Q&A
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 adapting trial oversight activities to the changing environment and prepare for the future.
SPEAKERS
| Steven Thys Steven is Director Global Clinical Operations at SGS Life Sciences since 2019. He has more than 19 years of experience in pharmaceutical R&D. As global RBM Project Director, he successfully developed and implemented a risk-based approach for the clinical development enterprise. |
| Joanna Zephirin Joanne is a CRA Manager working for more than 11 years at SGS Life Science Services. She has over 18 years of Clinical Research Industry experience. In her current role as CRA Manager Joanne directly managed as many as 40 CRAs across 8 projects in various phases. |
| Session Schedule |
| 10:00 AM New York City (USA) 3:00 PM London (United Kingdom) 4:00 PM Paris (France) 10:00 PM Singapore (Singapore) Can’t make a live session? Register now and receive a complimentary recording after the live event. |