This eLearning module is designed to provide an overview of the principles and frameworks used in benefit-risk assessments, focusing on regulatory requirements and the role of patient experience in decision-making. By the end of this module, learners will gain a deeper understanding of the key concepts, tools, and methodologies essential for performing benefit-risk evaluations in various regulatory settings, including the FDA and ICH frameworks. Key terminology used in benefit-risk work and clarity on qualitative and quantitative assessment approaches will be reviewed. Additionally, the module will highlight the increasingly vital role of patient input in the benefit-risk evaluation process. Methods to integrate patient experiences and perspectives will also be explored, recognizing their importance in maintaining a balanced benefit-risk profile.

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