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Session 4 Track A - Transparency and Oversight: Premarket Transparency in the Review of Health Products
Session Chair(s)
Maggie Graham
Senior Policy Analyst, Natural and Non-Prescription Health Products Directorate
Health Canada, Canada
Regulators are becoming more open and transparent about the decisions they are taking and the information that is made publicly available. This session will provide an overview of Health Canada’s premarket transparency initiatives as it relates to in the evaluation of health products, impacts to patient safety, and the industry perspective.
Speaker(s)
Submissions Under Review and Regulatory Decision Summaries: Premarket Transparency in the Health Products and Food Branch
Laura Johnson
Health Canada, Canada
Project Manager
Impact of Transparency Initiatives
Laurie Proulx
Canadian Arthritis Patient Alliance, Canada
Steering Committee Member
Retrospective Analysis of Health Canada’s Summary Basis of Decisions Database
Mukesh Kumar, RAC
Regxia, Inc., Canada
Regulatory Affairs Associate
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