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Comparison of the US Package Insert and the EU Summary of Product Characteristics

Time

Wed, Jun 26 11:45AM
W 16

Title

Comparison of the US Package Insert and the EU Summary of Product Characteristics

Abstract Summary

A standardized data collection tool was used to evaluate US and EU product information for nine drugs in three therapeutic areas. The drugs were selected due to their Physician’s Labeling Rule (PLR) Format for the USPI and by the availability of SmPCs; allowing for a consistent comparison.

Poster Presenter

Jay K. Bordoloi
PharmD,
Post-Doctorial Fellow,
Genentech, A Member of the Roche Group
United States

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