Responsive Regulatory Action from Signals in Post-Marketing Surveillance — Toxicity Case Studies

This module addresses the significance of post-marketing pharmacogenomic (PGx) surveillance and its role in integrating research findings into clinical practice. Through toxicity case studies, it examines how safety signals identified in post-marketing data lead to regulatory action. The module incorporates adapted examples from the CHMP guidelines and the EMA regulatory pathway for 5-fluorouracil (5-FU), demonstrating how DPD deficiency toxicity signals prompted PRAC to recommend changes to product information. It concludes with a case study using clozapine as an exemplar, assessing PGx signal evidence and clinical actionability for neutropenia risk.

access the FREE course here: https://portal.bpsassessment.com/cersi-pgx-elearning-portal/