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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

13th July 2016 - 14th July 2016
Chicago, United States


Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.Note: Use coupon code NB5SQH8N and get 10% off on registration.

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