Sean Schofield

Sean Schofield, PharmD, is Principal Specialist, Regulatory Affairs, PPD clinical research business of Thermo Fisher Scientific, Morrisville, NC, USA

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    Journal

    The role of artificial intelligence in regulatory affairs

    2025-01-10T08:54:00

    This article explores the enormous potential of artificial intelligence (AI) technologies in regulatory affairs, highlighting how AI can streamline regulatory compliance, expedite submissions, enhance predictive analytics for decision-making, improve pharmacovigilance and elevate regulatory intelligence when properly applied. The discussion covers not only the advantages of AI but also the complexities of integrating AI into regulatory affairs, such as the challenges of algorithm interpretability, data quality, regulatory compliance, fairness, security, privacy and model accuracy. Additionally, it emphasises the collaborative efforts of the global regulatory community in developing guidelines and frameworks for the safe and effective use of AI.

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    Journal

    Controlled substances development – past, present, and future

    2023-11-03T00:05:00

    Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...