PART 1 | From Theory to Practice: Real-World RBQM Workshop
Registration for the webinar
Currently there are no future dates for the webinar.
RBQM Cross-Functional Stakeholders
Study Manager
(by Anastasia Shapovalova, MSc)
Anastasia is a recognized leader with over 20 years of experience in pharmaceutical operations and business development. She brings deep insights from her broad experience with major companies such as GSK, Pfizer, Eli Lilly, and Cyntegrity.
Renowned for her expertise in business analytics and strategic planning, she's driven growth and efficiency, honing her proficiency in Clinical Trial Risk Management. Her noteworthy accomplishments at Cyntegrity, including leading projects in clinical trials fieldwork, risk analytics, and central monitoring, underscore her comprehension of Risk Management, Operational Efficiency, and SDV Reduction.
Data Manager
(by Ritwika Kar, PhD)
Ritwika holds a PhD in Molecular Biology and currently serves as a Project Manager at Cyntegrity. In her role, she supports both customers and team members on various RBQM projects.
Her project management journey involves conducting risk assessments from the study protocol stage, developing the RBQM system, and ultimately implementing it for clinical studies. Through her involvement in retrospective analyses of completed studies, Ritwika has learned how these insights can help identify prospective pain points in clinical trials. By gathering lessons learned from these analyses, she aims to highlight risk histories and critical processes that will contribute to the success of future clinical trials.
Risk Manager
(by Johann Proeve, PhD)
Johann Proeve has over 40 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.
Johann holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg (MSc in Pharma-ceutical Medicine program).
Central Monitor
(by Kateryna Bolshakova, MD)
Kateryna Bolshakova, with a robust background in clinical trials, currently serves as a Jr. Central Monitor at Cyntegrity. In her role, she leverages over six years of experience in IB-III clinical trials, focusing on oncology and respiratory tract diseases, including COVID-19.
Kateryna's journey began as a Clinical Oncologist and Sub-Investigator at LLC "ONCOLIFE" in Ukraine, where she managed study files, consented subjects and handled investigational products. She then transitioned to roles at Covance and MSD Ukraine, where she further honed her skills in clinical trial coordination and research.
At Cyntegrity, Kateryna supports data science initiatives for clinical trials, ensuring meticulous monitoring and quality management.
Workshop Overview - Part 1
Join us for the first part of our special workshop, which will simulate a real-world RBQM stakeholder meeting. By popular demand from MyRBQM Academy followers, we will demonstrate how the theory is applied in a real RBQM system, Cyntegrity's MyRBQM Portal.
Due to the success of our initial workshop on June 26, we are repeating it with two shorter sessions and increased interaction with attendees. Additionally, we will include whiteboard brainstorms and polls.
Workshop Details, Part 1 & 2:
Dates: July 30 and 31
Duration: 1.5 hours per session
Materials Provided Upon Registration:
>> ract-creation-training-material-protocol-ai-generated.pdf
>> rbqm-workshop-critical-data-critical-processes.pdf
Materials Provided Post-Webinar:
>> real-world-rbqm-workshop-by-cyntegrity-2024-06-26-1.pptx
>> Decision-making scheme for assigning KRIs and/or creating mitigation actions
>> KRI-Risk firing likelihood diagram
>> PD KRI likelihood setting logic
>> 30% discount voucher for the RBQM Essentials – Green Belt e-Training
High-Level Program, Part 1 & 2:
USE CASE & STAKEHOLDERS:
- Pre-reads: Protocol to be used for RACT
- Protocol and Use Case
- Metric identification: From metric to thresholds and KRIs
RACT:
- Develop RACT with "Ask AI" (1-3 risks per category)
- Launch RACT
RISKS:
- Associate default KRIs
- Develop custom KRIs
- Set likelihood percentages
- Correct risk scores
- Check KRI configuration
- Create mitigation actions
WRAP-UP and Q&A:
- Re-launch RACT
- Download IQRMP
- Open Q&A session
Register for Part 2, where we will continue to build on the concepts and activities from Part 1.
Learn more about MyRBQM Portal: https://cyntegrity.com/rbqm-software/