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Pharmacovigilance (PV) Literature Searches

A Whitepaper on optimizing search strategies for patient safety

Information obtained from medical and scientific literature is an important source of patient safety data and can contribute enormously to the safety profile of a medicinal product.  It is a regulatory requirement for the marketing authorization holder (MAH) of a medicinal product to perform regular searches of the scientific literature, including any unpublished manuscripts and abstracts presented at medical or scientific conferences.

Within this whitepaper we will explore;

  • The different types of literature searches
  • Regulatory requirements
  • Literature search strategy and how these should be constructed in such a way to ensure the optimum retrieval of the most appropriate articles
  • The implications of inadequate literature searches
  • When to start literature searches
  • Examples of inspection findings

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