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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