A Detailed Description of a Pharmacovigilance System (DDPS) is a comprehensive document that an applicant includes in a Marketing Authorization Application (MAA). This document outlines the applicant’s plan for establishing and operating a pharmacovigilance system for a specific pharmaceutical product. The DDPS provides detailed information on the procedures, strategies, and resources that will be employed to monitor the safety of the drug once it is on the market.
It typically includes details on adverse event reporting, risk management plans, data collection and analysis, communication strategies, and compliance with regulatory requirements. This document is a critical component of the MAA, as it demonstrates the applicant’s commitment to ensuring the ongoing safety and efficacy of the pharmaceutical product.
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