Regulatory Submissions, Information, and Document Management Forum

This session brings together representatives from the industry and a regulatory agency (Health Canada) to provide two perspectives on labeling management and the use of labeling information. The industry representative provides an in-depth of knowledge in headquarters and affiliate requirements regarding the process of label content tracking including an overview of technology identified to support these activities. Health Canada’s Structured Product Monograph initiative will lead to the adoption of HL7’s normative SPL standard. The benefits of transitioning from PDF to XML and international data standards will be shared. This session will provide a well-rounded view of industry and regulatory insights on labeling management.