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

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


    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.




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Last update 4 October 2019

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