What Is the Difference Between Pbrer and Dsur? A Guide to Pharmacovigilance Reporting
•
3 min read
According to the International Council for Harmonisation (ICH), aggregate safety reports provide a systematic, periodic collection and synthesis of safety information. Understanding the difference between Pbrer and Dsur is therefore critical for pharmaceutical sponsors, as these documents serve distinct purposes during different phases of a drug’s lifecycle. This guide delves into the specific roles, timing, and content of each regulatory filing.
