Generative AI offers significant potential to revolutionize pharmacovigilance by improving efficiency in data processing and insights generation. However, its implementation poses challenges, including data privacy, quality, and integration issues, as well as the need for human oversight. Experts emphasize the importance of responsible AI deployment, with clear strategies, continuous validation, and human involvement to manage risks and ensure accuracy. While generative AI is not perfect, it holds promise for enhancing regulatory document preparation and clinical outcomes, offering substantial long-term benefits for life sciences companies.

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