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Event Details
Developing and assembling an eCTD requires a working knowledge of practical techniques associated with metadata. This seminar will review the submission metadata required by ICH, FDA and other agency specifications, discuss the impact it has on the submission outline (such as repeating of sections), and summarize the decisions that need to be made concerning metadata. If you are involved in the preparation and assembly of the eCTD, you will not want to miss this briefing.
When & Where
Webcast Event
Conference Call,
19103
Wednesday, October 22, 2008 from 11:00 AM to 12:00 PM (ET)
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Hosted By
GlobalSubmit Product Team
GlobalSubmit is a products and services company that provides transparency in regulated healthcare products. The U.S. Food & Drug Administration and leading life sciences companies use our flagship applications, REVIEW™ and VALIDATE™, to review and validate electronic submissions. GlobalSubmit leads international efforts, comprising industry and government agencies, to standardize product and study information. The company is headquartered in Philadelphia, Pennsylvania.
