Periodic Adverse Drug Experience Report (PADER) is a part of post-marketing cumulative safety reports that need to be submitted to the United States Food and Drug Administration (US FDA). It provides a brief summary of changing post-approval AE profiles and safety information of an approved drug along with the benefit-risk profile evaluation. The Oracle Argus […]
Kruthi Roudur
Kruthi is working with clients on Argus Safety product suite and has successfully led multiple Argus Safety projects for implementations, upgrades, integrations, validation as a subject matter expert (SME), Validation lead, and configuration lead for many pharmaceutical companies.
