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Virtual Event

Oct 19, 2020 9:55 AM - Oct 20, 2020 5:30 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA Annual Canadian Meeting

Session 6 Track B: Real-World Data and Real-World Evidence

Session Chair(s)

Melissa  Hunt, MSc

Melissa Hunt, MSc

Director

Health Canada, Canada

Yatika  Kohli, PhD, MBA

Yatika Kohli, PhD, MBA

Chief Regulatory and Strategy Officer

NoNO Inc, Canada

Judith  Mergl, MSc

Judith Mergl, MSc

Head of Regulatory Affairs and Operational Services, Canada

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)

Caroline  Healy, MSc

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

Amber  McLeod, PhD

Adopting Work Sharing as a Global Filing Strategy Industry

Amber McLeod, PhD

Abbvie Corporation, Canada

Immunology, Virology, and Specialty Head, Regulatory Affairs

Cristina  Oliva, MD

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

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