Demanding More From AI Governance In Drug Safety

By Marie Flanagan, Regulatory and AI Governance Lead, Safety Technologies

As the use of AI continues to evolve across the pharmaceutical space, drug sponsors and vendors are determining how to safely implement this technology into existing workflows to add efficiency and reduce burden on their teams. However, the regulatory landscape is currently in flux and marketing authorization holders must also ensure continuous compliance with the latest regulatory guidance. Though regulators are largely encouraging the use of AI in drug development and manufacturing, the majority of guidance is still in draft form with the potential to change as the industry’s knowledge grows.

One solution to build a robust, compliant, and reliable AI system into your PV and safety workflows is to establish AI governance, which considers the entirety of an AI model to establish regulatory adherence at every stage of use. Embedding AI governance by design empowers trust in an AI-enabled safety system and streamlines the path toward success. Download the full whitepaper to learn more about current regulatory guidance for AI in PV and drug safety as well as how to formulate your approach to AI governance.