FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
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Category Clinical Compliance;
Deadline: August 31, 2017 | Date: August 31, 2017-September 01, 2017
Venue/Country: Opfikon, U.S.A
Updated: 2017-08-14 14:52:09 (GMT+9)
Call For Papers - CFP
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.The following steps to establish the appropriate manufacturing environment for phase 1 investigational drugs should be taken:A comprehensive and systematic evaluation of the manufacturing setting (i.e., product environment, equipment, process, personnel, materials) to identify potential hazardsAppropriate actions prior to and during manufacturing to eliminate or mitigate potential hazards to safeguard the quality of the phase 1 investigational drugReview the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.Who will Benefit:DirectorsManagerSupervisorsLead workers in Regulatory Affairs Quality Assurance and Quality ControlWorkers who will prepare GMP documents for early phase productsWorkers who will review GMP documents for early phase productsNote: Use coupon code REFERRAL10 and get 10% off on registration.For Registration:http://www.complianceonline.com/fdas-new-import-program-concerning-international-consequences-seminar-training-80489SEM-prdsm?channel=ourglocal
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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