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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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Development of a Clinical Study Report | |
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October 26, 2007 |
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Drug Information Association, Philadelphia Marriott Downtown, 1201 Market Street, Philadelphia, PA, USA
Feb 5 2008
Examine best practices for preparing integrated clinical study reports for pharmaceutical products. Discussion will focus on the structure and format of a clinical study report, with special attention given to the inclusion and presentation of study-specific information and data.COURSE HIGHLIGHTS·Structure and format of an integrated clinical study report in accordance with ICH guidelines·Investigational plan through statistical methodology·Study population and protocol deviations·Placement and presentation of study information and data in various report sections, including tables, appendices, and supporting documentation ·Safety and efficacy results ·pharmacokinetic and/or pharmacodynamic endpoints·Acceptability of abbreviated study reports.
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Organized by:
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Drug Information Association |
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Invited Speakers:
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Patricia Matone, PhD, Scientific Information Services, LLC.
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Deadline for Abstracts:
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-
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Registration:
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On our website.
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E-mail:
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dia@diahome.org
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WWW: Kai Garlipp,
Frank S.
Zollmann.
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