Event Date/Time: Sep 26, 2006
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End Date/Time: Sep 27, 2006 |
Description
Late in 2005, Structured Product Labeling replaced PDF as the required format for electronic content of labeling submissions in the US. Concurrently, Product Information Management (PIM) became optional in the EU for labeling submitted as part of a Centralized Procedure review. Both labeling initiatives are based on the use of XML standards, but have different approaches and business drivers. Join your peers in Regulatory Affairs and Labeling in discussing lessons learned from implementing these standards, hear from the Health Authorities who are utilizing them and share strategies for managing global labeling components. Also, find out what potential impacts the Physician’s Labeling Rule will have on the content of labeling.
Venue