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






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If you are interested in sponsoring any of the US SDEs please download the Sponsorship Application Form and the SDE T&Cs.


How do I join the PhUSE Society?

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1. Click through to the on-line registration website by clicking here.

2. Contact for multiple membership applications or for invoicing arrangements.



PhUSE US Computational Science Symposium 2017

The PhUSE Computational Science Symposium (CSS) will be celebrating its 6th annual event in 2017, having established itself as the premier collaboration within the clinical trial environment. The collaboration has continued to grow, hosting its inaugural event in Europe during 2016 and engaging other regulatory agencies including the EMA and PMDA.

This year's event will once again be co-sponsored by the FDA and PhUSE and will bring together academia, regulators, industry and technology providers to address computational science needs in support of regulatory review.

Find Out More