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The Role of Product Identification Systems in Pharmacovigilance (PV) for Biologics in the Biosimilars Era

Time

Wed, Jun 26 11:45AM
W 20

Title

The Role of Product Identification Systems in Pharmacovigilance (PV) for Biologics in the Biosimilars Era

Abstract Summary

Case studies relevant to PV of multisource biologics were identified in peer-reviewed literature, US legislation, FDA regulatory guidance, and MedWatch/CDC safety reports. Robustness and potential utility of multiple biologic product identifiers in the context of the PV system were evaluated.

Poster Presenter

Thomas Felix
MD,
R&D Policy Director,
Amgen Inc.
United States

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