This Friday, I write about two concepts in Pharmacovigilance. Even if its a short to the point kind of article, these two concepts are important to understand for all PVG professionals and patients who take these medications alike. Without further ado, lets jump right in! Black box warning: A warning that appears on…

This is an article about RMPs- Risk Management Plans in PVG and important concepts to understand. I have divided it into two parts, the first has concepts that need to be understood and are described in detail. Whereas the second half of the article has 27 key definitions relevant to…

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 them…