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Globalization of the Safety Sections of the Periodic Safety Update Report

Abstract

The recent implementation of the International Conference on Harmonization’s E2C Guidelines was an important step toward globalizing the activities of drug safety departments. While many details have not yet been addressed, the primary objective of this initiative is clear: the preparation and worldwide submission of standardized periodic reviews of a marketed product’s safety record. This article presents a strategy for integrating suréillance activities and epidemiological principles into periodic safety update reporting (PSUR), while at the same time meeting the regulatory requirements set forth in the ICH E2C Guidelines. A stepwise approach to PSUR compilation, interpretations of critical subsections of the ICH E2C Guidelines, and issues unique to the United States reporting environment are discussed.

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Correspondence to Stephen L. Klincewicz DO, MPH, JD.

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Klincewicz, S.L., Clark, J.A., Arnold, B.D.C. et al. Globalization of the Safety Sections of the Periodic Safety Update Report. Ther Innov Regul Sci 33, 887–898 (1999) doi:10.1177/009286159903300330

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Key Words

  • Periodic safety update reports
  • International Conference on Harmonization
  • Pharmacoepidemiology
  • Adverse event signaling
  • Postmarketing surveillance