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Session 5 Track 1 - New Frontiers: IT Modernization

New Frontiers

Day & Time:
October 30, 8:30AM - 10:00AM


Session 5 Track 1 - New Frontiers: IT Modernization

Paul Litowitz
Associate Director, Bureau of Metabolism, Oncology, & Reproductive Sciences, TPD
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.

Presentation(s) & Speaker(s):
Update on eSubmissions at Health Canada
Vianney Caron
Manager Electronic Regulatory Activities
Health Canada, Canada

FDA Electronic Gateway
Michael Blanchard Fauntleroy
Program Manager, CBER
FDA, United States

Health Canada and US FDA Common Electronic Submission Gateway
Vikesh Srivastava, MSc
Associate Director, Business Informatics Resource Management and Operations Dire
Health Canada, Canada

Adoption of Digital Identities
Janet E. A. McDougall, MS
President and Senior Statistician
McDougall Scientific Ltd., Canada

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