Pharmacovigilance Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Background: WHO established its Program for International Drug Monitoring in response to the thalidomide disaster detected in 1961 (Many children in the 1960’s were born with Phocomelia as a side effect of […]

The law governing pharmacovigilance lay down rigid details on what pharmaceutical firms must do in the event of analysing a serious adverse event and indeed what constitutes a serios adverse event. With these major demands on pharmaceutical firms, its essential for them to set up a right pharmacovigilance system and this might cause a various […]

Introduction Pharmacovigilance (PV) is fundamental to the Pharmaceutical and Biotech industries.  More now than ever, safety regulations are numerous and complex around the world. Regulatory authorities are requiring more safety documentation and review for product approvals and maintenance of the products license. Safety concerns have prompted global mandates for submitting significantly more product information.  There […]