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E174 | How AI is Transforming Regulatory Submission and Medical Writing in Biopharma

AI For Pharma Growth

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AI and Regulatory Evolution in Biopharma

This chapter explores the dynamic relationship between AI technologies and regulatory bodies in the biopharmaceutical sector, focusing on the FDA's proactive approach towards AI-generated documentation. Key discussions include the balance of human oversight with AI capabilities, the democratization of access for smaller companies, and the emphasis on scientific accuracy and security in documentation. The chapter also addresses the evolving role of medical writers amidst advancements in AI, highlighting both the benefits and challenges presented by these technologies.

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