Pharmacovigilance & Clinical Trials

Biography

Biography: Subodh Bhardwaj

Abstract

Vaccines pharmacovigilance is of utmost importance and necessary today, as millions of subjects are being immunized globally in the platinum Era of Vaccines with the introduction of 13 new Vaccines in this century . New Vaccines with safety profiles emanating from Clinical trials on a small sample size, would need active monitoring globally- to assess newer reactions post-licensure. Vaccines differ from drugs as they are preventive while drugs are curative. Vaccine related adverse events are immunologic and indicate immune response while drug reactions are undesirable effects. This has bearing on prevention, analysis , intervention and data interpretation. The vigilance gap between developed and developing countries needs to be improved. As Newer Vaccines are produced using sophisticated technologies, with novel adjuvants and unique routes of administration ( nasal)for LAIV, new challenges emerge for adverse events detection, analysis and management. This workshop aims to provide better insights , discuss methods for AE detection and management with real time case reports on rare adverse events; to commonly administered Bacterial and Viral vaccines. To make the researchers and managers be better prepared to manage AEs as per international guidelines. In conclusion, Vaccine Vigilance is the need of the hour as children are an extremely sensitive young group receiving up to 37 shots from birth to 6years. Clearly Vaccine safety has a narrow margin for error.