New FDA Draft Guidance for Clinical Data Standards-Thamar Draper-06/19/2012 - 8:30am

Event Information
Event Topic: 
New FDA Draft Guidance for Clinical Data Standards
Event Date: 
06/19/2012 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyale, CA
Speaker Information
Event Speaker: 
Thamar Draper
Event Speaker Title: 
Senior Director, Professional Services and Product Management
Event Speaker Company: 
Omnicomm Systems
Event Speaker Bio: 

Thamar Draper

Thamar Draper is a 20 year pharma industry veteran with expertise in project management, clinical software implementation and training. She is a subject matter expert in the areas of EDC systems, clinical data bases and clinical data standards. Ms. Draper is actively involved with CDSIC, a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. In her talk she will offer insight into this important and evolving area of clinical research. At Omnicomm Systems, Ms. Draper is a Sr. Director, Professional Services where she provides strategy for products, processes, services and applications for worldwide eClinical systems.

Event Details
Event Details: 

The US Food and Drug Administration (FDA) released new draft guidance for industry on February 17, 2012 on how sponsors and applicants should submit standardized study data to FDA in electronic format. With the latest draft guidance released in February it is clear that the agency is being more aggressive in its ‘recommendations’ about the use of data standards.
Join us on June 19 and learn how to navigate and benefit from the new draft FDA Guidance on Standardized Study Data:

Presentation Objectives:
• Gain an understanding of new draft FDA Guidance on Standardized Study Data released February 2012. This guidance establishes FDA’s recommendation that sponsors and applicants submit study data in a standardized electronic format
• Comprehension of importance of standards for data collection through to submission of data for a product filing and approval. Understanding of the standards recommended from a timing and trial phase perspective; applies to biologics, medical devices and pharmaceuticals
• Provide an awareness of the updates to the current standards in use
• Discussion of how the latest eClinical technologies can effectively and efficiently help companies comply with FDA guidance while also expediting clinical decisions and submissions