Why is Literature Search Important in Drug Safety and Pharmacovigilance

1. Why is Literature Search Important in Drug Safety and Pharmacovigilance

2. Why is Literature Search Important in Drug Safety and Pharmacovigilance Pharmacovigilance is a domain that works completely on drug safety through collection, detection, assessment, monitoring, and prevention of adverse effects associated with pharmaceutical products. It is a science that needs no introduction these days, thanks to increased vigilance in pharmaceutical drug discovery and development, as well as the introduction of new products to the market. For Drug safety or pharmacovigilance, data will be collected from different sources to understand and assess the drug, either in its development stage while doing clinical trials or after releasing it into the larger population to understand its safety and efficacy in a wide range of populations. Literature search, monitoring, and screening As we discussed above, the goal of literature search and monitoring is to identify individual case safety reports and any possible changes to the benefit-risk profile of the substance that is being monitored, particularly in relation to the detection of new safety signals or emerging safety issues. Marketing authorization holders should perform medical device regulation monitoring on their products from day one of product authorization until they are active, whether the product is in the market or not. All the medical literature published globally and locally should be monitored and screened for all the adverse events reported in that literature for ICSR processing, as the medical literature is an important source of information for the identification of suspected adverse reactions to authorized medicines. .

3. Why is Literature Search Important in Drug Safety and Pharmacovigilance • As we discussed above, the goal of literature search and monitoring is to identify individual case safety reports and any possible changes to the benefit-risk profile of the substance that is being monitored, particularly in relation to the detection of new safety signals or emerging safety issues. • Our experts work with you to understand the requirements and develop a search strategy based on your global and local literature data collection requirements. We will work with you to understand the purpose of your requirement, if it is for ICSR reporting, signal detection, or aggregate reporting, and provide you with a solution that meets the regulatory requirements while being compliant on timelines. • Schedule a discussion with our healthcare and life sciences experts to learn more about the criticality of literature search in Drug Safety and Pharmacovigilance. • Read the full blog to know more: • https://www.cigniti.com/blog/literature-search-drug-safety-pharmacovigilance/