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"very actual topics leading to interesting and open discussion"

Hays Pharma

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:

ADaM

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.

Presentations:

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


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