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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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Fundamentals of Clinical Research Monitoring | |
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November 16, 2007 |
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Drug Information Association, Sheraton Inner Harbor Hotel, Baltimore, MD, USA
Mar 10 2008
This introductory course describes the role and responsibilities of CRAs and their job function through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations pertinent to clinical monitoring. The content for this course focuses on drugs and biologics development. COURSE HIGHLIGHTS·Good Clinical Practices (GCP)·Regulatory requirements for clinical research·Clinical research methodology and its role in drug development·CRA’s role in clinical research·Monitoring clinical trials to ensure valid and useful study data·Investigator selection and evaluation·FDA audits·Basic HIPAA requirements·Basic protocol development.
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Organized by:
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Drug Information Association |
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Invited Speakers:
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1) Craig A. Metz, PhDVice President, CEDD Regulatory AffairsGlaxoSmithKlineUnited States. 2) Bernie OttConsultantUnited States. 3) Bruce M. Wagman, MBA, RN, RACVice President, Regulatory Affairs and Quality Assurance ServicesCovance Inc.United States.
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Deadline for Abstracts:
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-
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Registration:
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http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=15821&eventType=Training%20Course
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E-mail:
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dia@diahome.org
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