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Session 6 Track B: Real-World Data and Real-World Evidence
Session Chair(s)
Melissa Hunt, MSc
Director
Health Canada, Canada
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer
NoNO Inc, Canada
Judith Mergl, MSc
Director, Regulatory Affairs and Operational Services
AbbVie Corporation, Canada
In a market that is constantly adapting and adjusting to healthcare needs, real-world evidence (RWE) is increasingly becoming important for regulatory and reimbursement decision-making. RWE, in relation to the real-world data that is collected in combination with the advancement of artificial intelligence-based analytics platforms, has led to the real-time analysis of data to better understand and gain insights on disease, approaches to treatment, and how to substantiate coverage decisions. RWE is now becoming integrated throughout the product development lifecycle, and this session will explore new and innovative applications of RWE and provide insights through case examples and practical applications on how stakeholders are leveraging RWE to advance healthcare knowledge and decision-making. This session will provide a high-level overview of the evolving regulatory landscape for RWD/RWE from a Health Canada, CADTH, and industry perspective.
Learning Objective : - Gain a greater awareness of Health Canada’s international collaborations in the COVID-19 space that are leveraging RWE and observational studies
- Provide an overview of premarket challenges with RWE as well as a high-level overview on details and limitations regarding some recent examples submitted by sponsors in the premarket setting
- Discuss “lessons learned” from current uses of RWE, and how these can be applied for other future HTA applications
Speaker(s)
The Australia, Canada, Singapore and Switzerland (ACSS) New Active Substance Work Sharing Initiative: Updates and Looking to the Future
Caroline Healy, MSc
Health Canada, Canada
Policy and International Coordination Advisor
Adopting Work Sharing as a Global Filing Strategy Industry
Amber McLeod, PhD
Abbvie Corporation, Canada
Immunology, Virology, and Specialty Head, Regulatory Affairs
A Contract Research Organizations Perspective on International Work Sharing and Collaboration
Cristina Oliva, MD
IQVIA, United Kingdom
Vice President and Head of Oncology Centre of Excellence