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, 2 July, 2020
Time: 03:00 PM GMT

Language: English
Cost: No Charge

SGS Next Normal Solutions

The COVID-19 pandemic is unprecedented in the modern era, posing unforeseen challenges to business continuity. At SGS, we are working hard to meet those challenges and support international efforts to beat COVID-19.

Find out more about our Next Normal Solutions >