Innovative Pharmacovigilance Practices for Enhanced Safety in Clinical Trials

Pharmacovigilance is the science and practice of collecting, identifying, and evaluating adverse event data. Pharmacovigilance's primary goal is to assess a drug's benefit-risk profile in order to improve patient safety and efficacy. Pharmacovigilance, which gives information regarding adverse drug reactions observed in patients, is crucial to the judicious use of drugs. The Indian pharmaceutical sector ranks third globally in terms of volume and thirteenth globally in terms of value. India is renowned for being a center for medication development and clinical research.For improved safety evaluation in India, a worldwide, uniform pharmacovigilance system is necessary. Ensuring patient safety both during and after clinical trials is the only priority in the medication development process.1 Patient safety monitoring is an essential part of the medication development process. Patient safety monitoring is given the highest priority at the lowest stages of drug development since patients must be treated according to their needs and conditions. In order to approach safety monitoring, such monitoring may be a dynamic process. The pharmaceutical sponsor must cooperate and engage proactively with all parties involved to guarantee a methodical approach to safety monitoring.We have to focus upon all the aspects of drug safety in clinical trials including basics of drug safety, regulatory aspects of drug safety, patient suitability for safety in trials, post marketing safety and causality risk assessment of the drug products.