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Comparison of post-authorisation requirements between regulatory agencies for medicinal products

  • At: Glasgow (Scotland) (2018)
  • Type: Poster
  • Poster code: POS-RSC-006
  • By: CAMILLERI, Matthew (University of Malta Department of Pharmacy)
  • Co-author(s): Matthew Camilleri
    John-Joseph Borg
    Nicolette Sammut Bartolo
    Anthony Serracino Inglott
  • Abstract:

    Background

    Information submitted during the initial registration phase of medicinal products may not be sufficient to fully assess the benefit-risk balance of the product. Post-authorisation studies for new medicinal products are often requested by regulatory agencies to address this limitation and better assess the product.

    Methods

    Medicinal

    ..

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Last update 28 September 2023

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