Pharmacovigilance remind that patent safety
😊Hello Everyone, For all the freshers stepping into Pharmacovigilance, it's very important to know about the historical incident "The Thalidomide Tragedy", which changed the face of drug safety forever. 💡What happened? In the late 1950s, Thalidomide was introduced as a sedative and treatment for morning sickness in pregnant women. Unfortunately, it was not tested on pregnant animals before approval. As a result, thousands of babies were born with severe birth defects (limb deformities, organ damage). 💡Reason for the tragedy ➡️Lack of proper clinical trials ➡️Absence of testing in pregnant animals ➡️Weak regulatory requirements for drug approval at that time 💡Changes after the tragedy ➡️Strict drug regulations implemented globally ~Mandatory animal studies, including reproductive toxicity studies ~More rigorous clinical trial phases before drug approval ~More rigorous clinical trial phases before drug approval ~Establishment of Pharmacovigilance systems to continuous...