The requirements and reports on individual cases and Pharmacovigilance

SOLLERS COLLEGE The requirements and reports on individual cases and Pharmacovigilance In order for pharmaceutical companies to comply with FDA regulations , they are required to submit Individual Case Safety Reports ( ICSRs ) . There are many important stakeholders that play an important role in ensuring public safety , such as pharmaceutical firms and regulatory bodies that receive ICSRs . A PV expert is needed to evaluate the case's validity as the first step in the ICSR process . In order to make an ICSR valid , there are four requirements that must be met in order for it to fulfill the following criteria : • A reporter who can be identified • A distinct patient • Suspected pharmaceutical product • Suspected negative reaction As a result of compiling these facts , the PV expert creates an ICSR by following a predetermined format that complies with the FDA's guidelines by following a set of facts and evidence . It is necessary to gather adverse events , conduct the necessary research , enter AES into the database , code the AEs with standard medical terms , and classify the AES into groups such as expected versus unexpected , serious versus non - serious , and related versus unrelated . As a result of the formulation and processing of an ICSR , ineffective pharmacovigilance can be associated with a large part of the inefficiency in pharmacovigilance . ICSRS will no longer be feasible for assessing PVS due to the significant increase in adverse events reported each year . Sollers College , 33 Wills Way Building , 9 Piscataway , NJ 08854 Phone : 732-806-7846 , 848-299-5900 | Email ID : [email protected] | Website : www.sollers.edu