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June 10, 2008 |
Pharma Development and Business |
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Drug Information Association, Four Points by Sheraton Washington DC Downtown
Sep 15 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. Key Topics· 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 HIPPA 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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Lauren M Kelley Director, Chesapeake Regulatory Group Chesapeake Regulatory Group United States. Bernie Ott Consultant United States. Karen E. Woodin, PhD President JKK Consulting LLC United States.
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Deadline for Abstracts:
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Sep 15 2008
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Registration:
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http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16085&eventType=Training Course
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E-mail:
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dia@diahome.org
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