Back to Agenda
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)
Jared Lantzy, PMP
Executive Director, Global Regulatory Operations, Novavax, Inc., United States
eCTD v4.0: The Path to Implementation
Khaled Yahiaoui, MSC, RAC
Associate Director, Regulatory Affairs - Operations, Merck Canada Inc., Canada
Innovation Through Regulatory Operational Processes: Impact on Compliance, Efficiency, and Competitiveness
Vianney Caron
Manager Electronic Regulatory Activities, Health Canada, Canada
Speaker
Have an account?