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"getting FDA at conference was a great addition"

AstraZeneca

PhUSE Northbrook, Illinois Single Day Event (SDE)


The Northbrook, Illinois Single Day Event was held on Thursday, September 27th 2012 at Astellas and was a great success with 80 attendees.

Theme:

From Protocol to CSR - A CDISC Journey

The CDISC Standards have been developed to facilitate the flow of data through the clinical life cycle. From protocol development through regulatory submission, there are CDISC standards in place, including data collection, tabulation data, pre-clinical data and analysis data to name a few. At the PhUSE Single Day Event in Northbrook, IL, industry colleagues will share their implementation experiences, what challenges they have faced and what lessons were learned.  This will include presentations on the implementation of CDISC Standards across the clinical data life cycle. 

Presentations:

Protocol Representation Model in the Real World!
David Gemzik, Pharmanet/i3

CDISC and the Study Team: Implementing CDISC from Protocol to CSR
Sandra Vanpelt Nguyen & Caryl Burke, Medidata Solutions Worldwide

The Great Consistency Debate - Challenges in SDTM Creation
Jim Zuazo, Justin Sjogren & Chris Hurley, MMS Holdings Inc.

Common Errors Seen Creating EX
Jerry Salyers, Octagon Research Solutions


ADaM Review from a CDER Statistical Reviewer's Perspective
Behrang Vali, FDA CDER

Need for Human Involvement in Checking for Compliance of Both SDTM and ADaM
Sandra Minjoe, Octagon Research Solutions

The Next Big Thing - Standardizing Map Metadata to Enable Metaprogramming
Greg Steffens, Novartis

FDA/PhUSE 2012 CSS Worksgroup Update
Frank Senk, AstraZeneca

Brochure:

Download the brochure here.


Sponsors:

PhUSE would like to thank the following sponsors for their support.