Development Pharmacovigilance and Risk Management Plan

The Development Pharmacovigilance and Risk Management Plan outlines a comprehensive strategy for executing activities associated with identifying, evaluating, comprehending, reporting, and averting adverse effects stemming from medicinal products during clinical trials. This plan is initiated in the early stages of development and remains subject to modification as required throughout the course of advancing a new drug or drug usage.

Its purpose is to ensure systematic and thorough management of potential risks, enabling the accurate assessment of product safety and supporting informed decision-making throughout the developmental trajectory.