A critical part of any pharmacovigilance (PV) system is the process of signal management. As per article 19 of the Commission Implementing Regulation (EU) No 520/2012, Marketing Authorization Holders (MAHs) are legally required to identify new or changing adverse events related to their medicinal product or Active Pharmaceutical Ingredient (API).
The challenge comes when deciding on how to identify, validate and act on these new adverse events in an appropriately scientific manner.