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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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Celebrating the Two-Year Milestone and Planning for the Future of Voluntary Genomic Data Submissions (VGDS) to the FDA | |
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September 01, 2006 |
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Drug Information Association, Online
Sep 28 2006
DIA Webinar offer the power and punch of in-person events—all from the convenience of your home or office. This 90-minute, introductory webinar will outline the benefits of a finalized Best Practices Document for the Submission of Data in a Voluntary Genomics Data Submission (VGDS)—the perfect appetizer for DIA’s upcoming two-day workshop, “Best Practices and Development of Standards for the Submission of genomic Data to the FDA.”
Webinar Highlights:
Panel discussion and Q&A with FDA representatives.
Spirited discussion of the VGDS experience.FEATURED TOPICS:
• Scientific accomplishments showcased in Voluntary Genomic Data Submissions (VGDS) over the past two years.
• Consensus from Q&A sessions about the added value of genomic data in regulatory review.
• New applications associated with VGDS, including other omic platforms and estimates for the impact of pharmacogenomic information in clinical trials.
• Role of VGDS in the Biomarker Qualification Pilot Process.
• Best Practices and Development of Standards in the Submission of Genomic Data to the FDA.
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Organized by:
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Drug Information Association |
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Invited Speakers:
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FEDERICO GOODSAID, PHD
Senior Staff Scientist, Genomics
Office of Clinical Pharmacology
CDER, FDAFELIX W. FRUEH, PHD
Associate Director, Genomics
Office of Clinical Pharmacology
CDER, FDA
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Deadline for Abstracts:
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Registration:
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http://www.diahome.org/product/12215/06244.pdf
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E-mail:
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dia@diahome.org
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