Submit RFI/RFP


Josefina Jakobsson, MSc Pharmacovigilance Specialist Biomapas

What is a Safety Signal?

By | news1, Uncategorized

Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.

Read More