This two-day workshop includes a series of presentations pertaining to the present state of the Best Practices Document, as well as what can be expected once the document becomes final later this year. Topics will include:
• 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.

SPECIAL FEATURES
Spirited discussion of the VGDS experience
Breakout sessions to discuss best practices and standards in the submission of genomic data.