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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