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HUM-MOLGEN -> Events -> Meetings and Conferences | ||||||||||||||||
IBC's Application of "Appropriate" cGMPs in Biopharmaceutical Drug Development | ||||||||||||||||
January 31, 2002 | ||||||||||||||||
IBC USA Conferences, Inc., Las Vegas, NV, Princeton, NJ, San Francisco, CA May 6-7, 2002, June 20-21, 2002, July 15-16, 2002 This two day course will cover the basic requirements for taking a “New Chemical Entity “ (NCE) from early stages of drug development to pivotal clinical trials. This will cover the basic requirements of GLPs, GMPs and GCPs. The instructor will discuss by way of examples how to interpret and apply the cGMP regulations (21 CFR 210, 211 and 600) for the manufacture and control of pre-clinical and clinical supplies. The application of these regulations in an “appropriate” manner is crucial to drug development. This course will also discuss the phases of clinical studies and how to use the “graded” approach to the manufacture of clinical supplies as a NCE progresses through drug development. |
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Organized by: | IBC USA Conferences, Inc. | |||||||||||||||
Invited Speakers: | K.A. Ajit-Simh, Principal, Shiba Associates | |||||||||||||||
Deadline for Abstracts: | - | |||||||||||||||
Registration: | Five Easy Ways to Register! Phone (508) 616-5550 Fax (508) 616-5522 E-mail reg@ibcusa.com Online www.LifeSciencesInfo.com/2747 IBC USA Conferences, Inc. One Research Drive, Suite 400A Westborough, MA 01581-5195 |
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E-mail: | reg@ibcusa.com | |||||||||||||||
Posted by: | James G. Prudhomme | |||||||||||||||
Host: | 208.252.12.3 | |||||||||||||||
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