Post-Marketing Safety Assessment: Innovative Design and Analyses in Multi-Regional Context

Music City Center 

Post-marketing safety assessment is a crucial aspect of drug development, aiming to ensure the continued safety and efficacy of pharmaceuticals across diverse populations. The International Council for Harmonization (ICH) , such as those in the E17 and M14, have provided essential guidance and frameworks to harmonize the drug development and post-marketing pharmacovigilance.

In this presentation, we examine various design considerations for such post-marketing safety studies. We will also evaluate statistical approaches in assessing drug safety , including aggregate and meta-analytical safety evaluation and consistency assessment across countries/databases. Moreover, the application of artificial intelligence (AI) methods may further enhances the capabilities of post-marketing safety assessments. Techniques such as prospective sequential safety monitoring , Bayesian methodology, or Retrieval-Augmented Generation (RAG), allow for the synthesis of diverse data sources. Together, these innovative designs and analytical techniques can advance the multi-regional post-marketing safety evaluation.

A case study on post-marketing risk assessment will be used to illustrate.