PhUSE SDE - Durham, North Carolina
Registration is Now Closed
The Raleigh-Durham Single Day Event was a great success with over 120 people attending.
Theme & Description:
The SDE will focus on issues related to ADaM implementation. Since the ADaM standard is flexible and is closely associated with best practices with respect to management of metadata and interpretation of traceability, ADaM implementation poses unique challenges.
Attendees can expect to gain insight in how organizations are approaching their implementation of ADaM and how particular issues have been solved.
Click on the links below to download the presentations.
PhUSE Introduction and Welcome - Susan Kenny, Amgen & Gustav Bernard, Quintiles
Considerations for an ADaM Submission - Jack Shostak & Chris Holland, Duke Campus Research Institute
You Cant Spell ADaM without Metadata- Jeffrey Abolafia & Ryan Burns, Rho Inc
CDISC Journey in Solid Tumor using RECIST 1.1- Kevin Lee, Cytel
PDUFA V, 21st Century Review, CDER Data Standards, PhUSE/FDA & ADaM: Getting it All Right - Stephen Wilson, FDA
ADaM Review from a CDER Statistical Reviewers Perspective- Behrang Vali, FDA
Challenges in Validation of ADaM Data - Sergiy Sirchenko & Max Kanevsky, Pinnacle 21
Moving your ADaM Metadata into Define 2.0 - Geoffrey Mann & ADaM Metadata Team, SAS Institute
Define-XML v2: Good for ADaM! - Lex Jansen, SAS Institute
PhUSE - Chris Decker, d-Wise Technologies
If you are interested in sponsoring any of the US SDEs please download the Sponsorship Application Form and the SDE T&Cs.
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