The Role of Pharmacoepidemiology in Regulatory Agencies

Gerald J Dal Pan, Peter Arlett

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The data sources and methods that underlie the discipline of pharmacoepidemiology have expanded greatly over the past several decades. This growth has involved academia, industry, and regulatory agencies. For drug regulatory agencies, pharmacoepidemiology is a core scientific discipline. Three key issues are highlighted that are of particular importance to drug regulators: using pharmacoepidemiology throughout a product's lifecycle; developing approaches to synthesize data from multiple sources; and building capacity in the field of pharmacoepidemiology.

Original languageEnglish (US)
Title of host publicationPharmacoepidemiology, Fifth Edition
PublisherWiley-Blackwell
Pages107-116
Number of pages10
ISBN (Print)0470654759, 9780470654750
DOIs
StatePublished - Jan 3 2012
Externally publishedYes

Keywords

  • Drug safety
  • Evidence-based decision making
  • Regulatory agency

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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  • Cite this

    Pan, G. J. D., & Arlett, P. (2012). The Role of Pharmacoepidemiology in Regulatory Agencies. In Pharmacoepidemiology, Fifth Edition (pp. 107-116). Wiley-Blackwell. https://doi.org/10.1002/9781119959946.ch8