Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy

Basic Details
Date
Tuesday, October 22, 2019
Type
Publication
Description

Healthcare databases are very useful sources of post-marketing real-world information, generating evidence on drug use, safety and effectiveness, particularly in populations where such information may be lacking in pre-clinical studies, such as paediatric and geriatric populations. However, healthcare databases can also provide pre-marketing information by measuring the burden of disease, identifying unmet clinical needs and estimating the number of patients potentially eligible for innovative and costly treatment. Whether in a pre- or post-marketing setting, these data sources can provide regulatory agencies with evidence that can inform the development/implementation of regulatory interventions and answer questions of high, and often urgent, public health interest. In April 2019, the Italian Drug Agency (Agenzia Italiana del Farmaco) organised a workshop on the role of healthcare databases in supporting drug regulatory agencies in their pre- and post-marketing regulatory activities. The experiences of the USA, Canada, Spain and Italy in this context were presented.

Author(s)

Janet Sultana, Francesco Trotta, Antonio Addis, Jeffrey S. Brown, Miguel Gil, Francesca Menniti-Ippolito, Federica Milozzi, Samy Suissa, Gianluca Trifirò

Corresponding Author

Gianluca Trifirò, Department of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.

Email: trifirog@unime.it