Pharmaceutical Software used in Pharmacovigil...

Pharmaceutical Software used in Pharmacovigilance

Author Name : Pooja Vishwakarma, Shivam Pal, Dr. Swaroop J. Chatterjee

ABSTRACT In this field of pharmacovigilance, worldwide, various pharmacovigilance systems and databases are used. These databases have very centrally come into vigilance of safety concerns following medication and medical products after the authorization and distribution process. The collection and analysis of adverse event reports in a timely manner enables early signals are possible safety concern, facilitate regulatory action, and contribute to the protection of the public health. This chapter spotlights the strengths of these databases – their ability to conduct signal detection, post-market surveillance, and enable research initiative among others. Further on, underreporting, reporting bias, and causality assessment which are subjects requiring great care were discussed.