A study on pharmacovigilance case processing

Abstract

Pharmacovigilance plays an vital role in modern technology which helps in monitoring and assessing the high-quality of Drugs, detection and stopping of any unfavorable outcomes of drugs. Pharmacovigilance starts with case processing: this involve safety data collection and coding, case management reporting and submission. In case of clinical trial, it is the investigator or in case of post-marketing trial, it is either the physician or the prescriber or the patient himself who reports the adverse event or any drug-related problem. Pharmacovigilance case processing helps to get clear information regarding the drug and outcomes by using various software technologies. Arugs database, cemflow, vigibase and ICSR are few software used nowadays. Case processing helps to monitor and track all serious adverse events, and medically significant ADRs and other medical related product information followed by timely processing and reporting of such information according with company and regulatory reporting.