CDISC Data Standards: Understanding the Guidance for Standardized Study Data

Join us for a complimentary workshop designed for professionals in the life sciences industry. 

Why Attend?

Beginning in December 2016, in an effort to standardize study data across the industry, the FDA will require that all data submitted for drug approval comply with CDISC standards. This will have an impact on the way the industry as a whole operates.

Attend this workshop to learn how to best prepare for these changes and understand any impacts this may have on your upcoming trials.  

Agenda

Registration and Continental Breakfast  

FDA Requirements and Expectations for Submission Packages 
Yuguang Zhao, MS, Vice President of Statistical Programming 

A Recipe for Successful Submissions: A Project Management Perspective
Lin Ye, MBA, Senior Director of Project Management 

Roundtable discussions 

Tips from the Experts: How to begin preparations for the changes and be successful 
Yuguang Zhao, MS, Vice President of Statistical Programming 

Dates / Locations: 

Tuesday, October 4, 2016
8 am – 11 am
Seattle, Washington
Register Here: http://cdiscstandardsmandate_fmdkl_seattleworkshop.eventbrite.com

Thursday, October 6, 2016
8:30 am – 11:30 am
Burlingame, California
Register Here: http://cdiscstandardsmandate_fmdkl_sanfranworkshop.eventbrite.com