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Session 3 Track B: Regulatory Operations
Session Chair(s)
Matthew Ryan
Senior Policy Analyst; Policy, Planning and International Affairs Directorate
Health Canada, Canada
The regulatory operations field is one that has always quickly evolved to leverage opportunities to improve processes through technological innovations in the areas of document and information management. These health authority initiatives also come with challenges and increasing complexities. In order to fully leverage these innovative technologies, process adaptation will be required. This session will provide participants with an overview of innovative technologies and processes available or are under development by Health Canada to improve operational effectiveness. Presenters will discuss the tools (REP, eCTD v4.0, SPL, ESG) and the strategies to fully leverage these innovations and highlight potential issues and challenges to overcome.
Speaker(s)
eCTD v4.0: The Path to Implementation
Jared Lantzy, PMP
Booz Allen Hamilton, United States
Lead Associate
Innovation Through Regulatory Operational Processes: Impact on Compliance, Efficiency, and Competitiveness
Khaled Yahiaoui, MSc, RAC
eCTD Now, Canada
President
Speaker
Vianney Caron
Health Canada, Canada
Manager Electronic Regulatory Activities