Artificial Intelligence (AI) and Big Data (BD) presents an unprecedented opportunity within the framework outlined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to enhance quality assurance, streamline drug development processes, increase traceability at supply chain level, and ultimately improve quality and safety of medicinal products. A new report generated by the ETERNAL Research and Innovation Action discusses the ethical considerations and legislative imperatives for integrating AI and BD within the ICH guidelines to ensure responsible usage and sustainable business outcomes.
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