戻る Agenda
Session 4 Track B - Regulatory Information and Data Standards: Recent Trends in Regulatory Information Standards
Session Chair(s)
Deirdre Cozier
Director, Global Regulatory Affairs
Pharmascience, Canada
From the eCTD to structured content, the pharmaceutical industry depends on massive amounts of critical data to ensure patient safety and regulatory compliance. The management and use of these data is crucial in ensuring that Health Canada meets its obligations to the Canadian population and can either enhance or hinder a firm’s ability to maintain compliance. This session will overview the recent trends in regulatory information standards and the challenges faced by the regulator and the industry in the collection and maintenance of these data.
Speaker(s)
Regulatory Enrollment Process
Vianney Caron
Health Canada, Canada
Manager Electronic Regulatory Activities
Structured Content
Vikesh Srivastava
Health Canada, Canada
Associate Director, Business Informatics Division, HPFB
Regulatory Information Management – An Industry Perspective
Craig Anderson
Group on Electronic Regulatory Activities (GERA), Canada
GERA Co-Chair, Pharmaceutical Regulatory Operations Consultant