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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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Regulatory I: The IND Phase | |
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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 course will offer insight into the regulatory background of the IND and outline the content and data requirements for an IND submission to FDA. The course will focus on drug and well-characterized biological products and not the regulatory process for devices, generic products or traditional biologics. COURSE HIGHLIGHTS·Overview of the drug development process·IND process ·Quality assurance in drug development (GXPs)·FDA’s actions on the original IND and amendments·Activities and submissions after the original IND·Interaction with FDA·Procedures for reporting adverse events (AEs).
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Organized by:
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Drug Information Association |
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Invited Speakers:
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1) Elliott T Berger, PhD, MSSenior Vice President, Regulatory AffairsBioCryst Pharmaceuticals, Inc.United States. 2) Stephen HorohonichVice PresidentAdvanced Research CorpUnited States. 3) David Zuchero, JD, MSPresidentChesapeake Regulatory GroupUnited 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=15814&eventType=Training%20Course
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E-mail:
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dia@diahome.org
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