Post-authorization safety studies (PASS) are important to conduct successful therapeutic risk management to support regulatory decision making. From retrospective to prospective study designs, using administrative data, electronic medical records, chart reviews, or primary data collection, the principles behind PASS are well-established.
A successful PASS can be relatively straightforward in theory, but theory and practice are not always aligned.
This webinar aims to provide insight into lessons learned from experience on multinational PASS. It will focus on the planning of a PASS, especially on important aspects of drug utilization studies, safety endpoint studies, studies for the evaluation of risk management interventions, and prospective studies that require data collection.
Attendees will also gain a better understanding of elements to be considered for successful study execution, data analysis, and interpretation of results.
