EMA just published this revised reflection paper entitled "Reflection paper on the use of AI in the medicinal product lifecycle"
While it covers the whole of pharmaceutical development and looks to assess and reduce risks, this sentence from the introduction best sums up the intent:
"Given the rapid development in this field, the aim of this reflection paper is to reflect on the principles that are relevant for regulatory evaluation when these emerging technologies are applied to support safe and effective development, manufacturing and use of medicines."
I'll be comparing the glossary at the end with the FDA's glossary that was published last week.
#EMA #artificialintellegence #DrugDevelopment
https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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