Dear RWE Collaborative Members,
We wanted to share ISPE's review of the FDA Draft Guidance on AI/ML in the latest issue of ISPE Insights! This brief highlights ISPE's key perspectives and contributions to shaping regulatory thinking on AI in drug development and real-world evidence.
Read it here: From Draft to Directive: ISPE Helps Shape the Path Ahead - International Society for Pharmacoepidemiology
Feel free to share your thoughts or reactions below - it's an exciting time for the RWE community!
Best Regards,
Tien
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Tien Tran
University of Maryland School of Pharmacy
Baltimore MD
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