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GMO Website Award Guidelines Usdf Form

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launched fully in today's agenda thank you again for being here so early I am honored to introduce our keynote speaker Dr Lawrence Yu is a director of The Office of New York products within fda's office of pharmaceutical quality opq he is also the rapporteur for the ich m4q R2 expert working group among his various accomplishments Dr you implemented a biopharmaceutics classification system at the FDA he described the pharmaceutical quality by Design qbd he inaugurated the FDA modern review system integrated quality assessment iqa developed the FDA historic concept of operations agreement to integrate review and inspection and originated a knowledge aided assessment and structured applications Casa initiative please help me to welcome Dr Lawrence Yu thank you thank you for the introduction good morning or good afternoon everyone welcome to the FDA DMF Workshop I'm Lawrence Yu director office new job products FDA at the last year's DMF Workshop I described

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