Safety concerns (risks- important identified risks, important potential risks and missing information) can be considered the most scrutinized and most important part of any safety document such as PSUR/PBRER or RMP. In PBRER, section 16 (esp 16.1 and 16.4) provide list and discussion on safety concerns whereas in RMP: part II, module SVII Identified and potential risks do. Safety concerns include important identified and important potential risks, and missing information and in this article I intend to discuss each of themβ¦