adverse event

I know this looks like a very basic topic and may not interest everyone working in the field of Pharmacovigilance. However, please note that numerous companies in developing countries (including the highly populated ones) may not have any Pharmacovigilance department. One of the main reasons why these companies hesitate to create one is because setting […]

When we think about expedited reporting of adverse events, the number 15 usually comes to mind first. It is the industry default: serious reports generally go out within 15 calendar days, and non-serious ones within 90. But that word “generally” hides a lot of complexity. While the 15-day rule is the golden standard in major […]