Register today to attend this Risk Based Quality Management (RBQM) digital week where trailblazers will share innovative approaches and best practices for enhancing processes and optimizing data quality to deliver improved risk management and trial efficiency in this rapidly evolving and dynamic space. This is your opportunity to discuss how the COVID-19 pandemic has irrevocably shifted the quality risk management landscape and identify where the industry will go from here. To learn about sponsorship of future events, contact partners@informaconnectls.com
DAY 1 – 6 December 2021
The Future of Clinical Monitoring
2:00pm GMT / 3:00 pm CET / 9:00am EST
Choices abound with risk-based monitoring (RBM) or risk-based quality management (RBQM). Remote monitoring and centralized monitoring are critical components of decentralized trail deployments.
You have a multitude of options, ranging from outsourcing your monitoring needs with a full service RBM implementation driven by your CRO or partner of choice, or you can implement your own monitoring platform, integrating your study processes for use across your portfolio, or every option in-between. In this presentation you will:
- Understand options when outsourcing your monitoring requirements
- Learn how to leverage your technology platform for additional trials
- Learn which monitoring approach is best, considering patient engagement options, connected devices and more
Speakers:
Zabir Macci
Director, Digital Trial Management Suite
IQVIA Clinical Technologies
Gayle Hamilton
Director, RBQM
IQVIA Clinical Technologies
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Covid-19 as catalyst for statistical monitoring for RBQM
3:00pm GMT / 4:00pm CET / 10:00am EST
- Closing the gap of issue identification by upscaling statistical monitoring
- Practical steps to improving data quality as new patterns to emerge
- How can statistical monitoring play a greater role in maintaining trial oversight?
- Missing data patterns have become a lot more relevant as pretty much all of the non-primary endpoint data is a part of this.
Speaker:
Julie Solbjerg Appel
Statistical Monitoring Specialist
Novo Nordisk
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Sharing Key Takeaways from Recent Regulatory Inspections and Future Planning Steps
4:00pm GMT / 5:00 pm CET / 11:00am EST
- Impact of COVID-19 of UCBs RBQM strategy
- Sharing practical aspects of UCBs risk-based audit strategy
- Prepare for FDA Inspection and findings: lessons learnt
- Leveraging inspection finding to further embed RBQM strategies to support clinical development
Speakers:
John (Jay) Daly
Risk Management Lead
UCB
Claudia Firkle
Study Data Risk Manager
UCB
Nikita (Nikki) Nayudu
Study Data Risk Manager
UCB
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DAY 2 – 7 December 2021
Risk-based Approaches for Active Oversight & Improved Monitoring
2:00pm GMT / 3:00pm CET / 9:00am EST
- Advanced statistical methods and data-driven review techniques supporting cross-functional collaboration
- Risked-based approaches to improve visibility and enable active oversight in an outsourced model
- Demonstration of illuminate platform capabilities for data-driven review and active oversight in both insourced and outsourced models
Speaker:
Thierry Escudier
Principal
DCRIPT Consulting
Jonah Brugger
Director, Product Management
eClinical Solutions
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QTL (Quality Tolerance Limits) and Critical Processes
3:00pm GMT / 4:00pm CET / 10:00am EST
- Understanding ICH guidelines and TransCelerate QTL framework
- How can QTLs be better embedded in clinical research
- Making QTLs work for your organisation: practical approaches for QTLs
Speaker:
Chris Wells
Senior Statistical Scientist
Roche
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