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Ottawa Marriott Hotel

17 oct 2017 7:00 a.m. - 18 oct 2017 3:00 p.m.

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

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Session 6B: Real-World Data

Session Chair(s)

Lisa Chartrand

Lisa Chartrand

Director, Regulatory Strategy and Policy

Hoffmann-La Roche Limited, Canada

We hear a lot lately about real-world data and how it will revolutionize the way we think about evidence. As ICH have reflected on this concept already, it is time now for industry, regulators, and patients in Canada to start thinking about how this evidence will be used, how it will foster research and innovation, how it will help with regulatory decision-making throughout the product's life cycle and ideally, from the patient's perspective, and how it could expedite access of medicines by looking at partnerships with industry, as well as government stakeholders to explore its full potential.

Speaker(s)

Basanti Ghosh, PhD, MBA

Health Canada: The Enhanced Use of Real-World Data

Basanti Ghosh, PhD, MBA

Health Canada, Canada

HPFB Marketed Health Products Directorate (OPEDA)

Speaker

Vikesh Srivastava

Health Canada, Canada

Associate Director, Business Informatics Division, HPFB

Michael Duong

Real-World Evidence: An Industry Perspective

Michael Duong

Hoffmann-La Roche Limited, Canada

Director, Evidence Generation, Medical Affairs

Barry D Stein

Should Real-World Data Impact Regulatory Decision-Making: A Patient’s Perspective

Barry D Stein

Coloretal Cancer Association of Canada, Canada

President and CEO

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