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
Nicolette Sammut Bartolo
Anthony Serracino Inglott
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.
Medicinal.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.