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Regulations to enable safe, effective, & high-quality AI, ML & Digital Solutions in Drug Development

From mobile medical apps and fitness trackers, to software that supports the clinical decisions that doctors make every day, digital technology has been driving a revolution in healthcare. As we learn to live in the new normal, forced by the COVID-19 pandemic, adoption of digital solutions has witnessed further acceleration.

To keep pace with this promising innovation, regulators must modernize their approach to regulation. The question is “How can we ensure high-quality, safe, and effective digital health products”.

This article focuses on the changing Regulatory landscape (European and FDA Guidelines) for enabling safe, effective, high-quality and trustworthy Artificial Intelligence (AI) and Digital solutions in Pharma.

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Article published in Pharma Focus Asia | 04 September, 2020

Sparta Systems

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