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

    View: 121

    Website http://bit.ly/2fElLXR | Want to Edit it Edit Freely

    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 hazards

    Appropriate actions prior to and during manufacturing to eliminate or mitigate potential hazards to safeguard the quality of the phase 1 investigational drug

    Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.

    Who will Benefit:

    Directors

    Manager

    Supervisors

    Lead workers in Regulatory Affairs Quality Assurance and Quality Control

    Workers who will prepare GMP documents for early phase products

    Workers who will review GMP documents for early phase products

    Note: 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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