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Session 5 Track 1 - New Frontiers: IT Modernization
Session Chair(s)
Paul Litowitz, MBA, RAC
Manager, Public and Regulatory Affairs Outreach Section
Health Canada, Canada
This session will present the overall features of IT modernization in the areas of HC website, esignature and the electronic Gateway for Market Authorization Holders and Clinical Trial Sponsors. Discussion will focus on the objectives achieved so far and the challenges of modernization moving ahead for regulators and impact on the industry. A goal of collaboration for Health Canada and the FDA is to better align regulatory systems, reduce unnecessary duplication’s and differences, and to the extent feasible, better leverage technologies and resources to help both agencies meet public health missions within the parameters allowed by prevailing laws and regulations subject to available human and financial resources. This session aims to provide updates in regard to the implementation of an electronic platform to support the review process, the implementation of the common electronic submission gateway as well as discussion in regard to industry’s adoption of digital identities and SAFE signatures.
Speaker(s)
Update on eSubmissions at Health Canada
Vianney Caron
Health Canada, Canada
Manager Electronic Regulatory Activities
FDA Electronic Gateway
Michael Blanchard Fauntleroy
FDA, United States
Program Manager, CBER
Health Canada and US FDA Common Electronic Submission Gateway
Vikesh Srivastava
Health Canada, Canada
Associate Director, Business Informatics Division, HPFB
Adoption of Digital Identities
Janet E. A. McDougall, MSc
McDougall Scientific Ltd., Canada
President and Senior Statistician
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