Annual Conference Conference 2014 Keynote Speakers 2014 CSS 2015 Presentations & Posters CSS 2014 Presentations & Posters Conference 2013 Keynote Speakers 2013 CSS 2013 Presentations & Posters Conference 2012 Keynotes 2012 CSS Conference 2012 CSS 2012 Presentations & Posters Conference 2011 Keynotes 2011 Conference 2010 Keynotes 2010 Conference 2009 Keynote 2009 Conference 2008 Keynote 2008 Conference 2007 Conference 2006 Conference 2005 Copenhagen, Denmark 2015 SDE Paris, France, 2015 SDE London, UK 2015 SDE New York, NY, USA 2015 SDE Chicago, Illinois, USA 2015 SDE Frankfurt, Germany 2015 SDE Mumbai, India 2015 SDE Chapel Hill, NC, USA 2015 SDE Tokyo, Japan 2015 SDE Frankfurt, Germany 2014 SDE Boston, MA 2014 SDE Durham, North Carolina 2014 SDE Basel, Switzerland 2014 SDE Copenhagen, Denmark 2014 SDE London, UK 2014 SDE Indianapolis, Indianna 2014 SDE Chennai and Pune, India 2014 SDE Bridgewater, New Jersey 2014 SDE Bangalore, India 2014 SDE Brussels, Belgium 2014 SDE Tokyo, Japan 2014 SDE San Francisco, California 2014 SDE Shanghai, China 2014 SDE SDE Basel 2013 SDE Beerse 2013 SDE Copenhagen 2013 SDE Frankfurt 2013 SDE Boston, MA 2013 SDE Durham, NC 2013 SDE Canton, MI 2013 SDE Redwood City CA 2013 SDE Wayne, PA 2013 SDE Hyderabad, India 2013 SDE Mumbai 2013 SDE Shanghai 2013 SDE Belgium 2012 SDE Denmark 2012 SDE New Jersey 2012 SDE California 2012 SDE Illinois 2012 SDE Switzerland 2012 SDE Germany 2012 SDE UK 2012 SDE Copenhagen 2011 SDE Brussels 2011 SDE Frankfurt 2011 SDE London 2011 SDE Philadelphia 2011 SDE San Francisco 2011 SDE North Carolina 2011 SDE Boston 2010 SDE Basel 2010 SDE Brussels 2010 SDE Copenhagen 2010 SDE London 2010 SDE Basel 2009 SDE Brussels 2009 SDE Frankfurt 2009 SDE London (CDISC) 2009 SDE London (PSI) 2009 SDE Middlesex (CDISC) 2008 GPP Membership Pharmaceutical Programming PhUSE Tube What is PhUSE PhUSE Wiki Newsletters 2015 SDEs Publications PhUSE Conference Archive Clinical Data Science Computational Science Symposium CS Working Groups PhUSE Tube Blog

Linked In Icon Twitter Icon Facebook Icon

"In a clear presentation it gave a perfect insight into our struggle with SDTM and legacy data"


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


Venue Sponsor

Lunch Sponsor

Break Sponsor

General Sponsor

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?

There are two easy ways to join PhUSE:

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

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