Webinars 2014 - 2016 

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16th November 2016: CS Working Group Project Updates

Standard Analyses & Code Sharing Working Group: Update on Projects Mary Nilsson, Eli Lilly
Clinical Program Design & Development Framework Mary Banach, Vanderbilt Medical Center
Define-XML 2 Stylesheet Recommendations Lex Jansen, SAS Institute
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26th October 2016: Preview of PhUSE 2017 Annual Conference & CSS 2017

Annual Conference 2017 Preview Jules van der Zalm, Conference Chair
Looking Ahead to CSS 2017: What's Next for the Semantic Technology Working Group? Tim Williams, UCB
CSS 2017 Registration Overview & CS Collaboration Wendy Dobson, PhUSE Office
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21st September 2016: PhUSE CS Working Groups: New Projects

SDTM/ADaM Implementation FAQ Bhavin Bhusa, Softworld
Data Consistency: SEND Datasets & Study Report Maria Francomacaro, Merck
Nonclinical Scripts Assessment Kevin Snyder, FDA
Test Dataset Factory Peter Schaefer, Validated Cloud Applications
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24th August 2016: PhUSE CS Working Groups: Marching to March 2017

Preparing for CSS 2017 & Semantic Technology Scott Bahlavooni, d-Wise
Standard Analyses & Code Sharing Mary Nilsson, Eli Lilly
Optimizing Use of Data Standards Jane Lozano, Eli Lilly
Nonclinical Topics Susan DeHaven, Sanofi
Emerging Trends & Technologies Geoff Low, Medidata
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27th July 2016: EU CSS 2016 Review with Project & Working Groups Update

EU CSS Review & SDTM Chris Decker, PhUSE/FDA Liaison
Statistical Computing Environments Nigel Montgomery, Novartis
Alternative Transport Formats Geoff Low, Medidata
De-identification Khaled El Emam, Privacy Analytics
Nonclinical Topics Philippe Marc, Novartis
Process Optimisation Chris Price, Roche
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30th June 2016: Japanese Webinar

Nonclinical Working Group Yuki Ando, PMDA
PhUSE CS Collaboration - with Japanese Translation Chris Decker, d-Wise

25th May 2016: EU CSS 2016 Project Presentations

Welcome & EU CSS Update Chris Decker, d-Wise
Experiences With Statistical Computing Environments Nigel Montgomery, Novartis
Evaluate & Prototype Alternative Transport Formats for Submission Geoff Low, Medidata
De-Identification of ADaM Datasets Jean-Marc Ferran, Qualiance
Nonclinical Road-map & Impacts on Implementation Philippe Marc, Novartis
SDTM Implementation FAQ Bhavin Busa, Softworld Inc
PhUSE Future Forum: Process Optimization Chris Price, Roche
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27th April 2016: CSS Debrief & Working Groups Update

Welcome, CSS Debrief & EU CSS Scott Bahlavooni, d-Wise
Semantic Technology Tim Williams, UCB
Development of Standard Scripts for Analysis & Programming Mary Nilsson, Eli Lilly
Nonclinical Road-map & Impacts on Implementation Susan DeHaven, Sanofi
Optimizing the Use of Data Standards Jane Lozano, Eli Lilly
Emerging Trends & Technologies Ian Fleming, d-Wise
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23rd March 2016: 2016 Annual Conference Preview & PhUSE CS Update

Welcome & Annual Conference Update Åsa Carlsheimer, Annual Conference Chair
Introduction to the New 'Real-world Evidence' Stream Berber Snoeijer & Knut Mueller, Stream Co-Chairs
Challenges of Sequential Treatment Analysis Edith Heintjes, Scientific Research Manager, PHARMO
PhUSE CS Update: CSS 2016 Highlights & Preview of EU CSS 2016 Chris Decker, PhUSE/FDA Liaison & Scott Bahlavooni, Senior Consultant d-Wise
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24th February 2016: PhUSE CS Working Groups
Marching to March 2016: CSS 2016 Working Group Sessions

Introduction & CSS 2016 News & Agenda Chris Decker, PhUSE/FDA Liaison
Optimizing the Use of Data Standards DJ Chhatre, Gilead
Development of Standard Scripts for Analysis & Programming Mary Nilsson, Eli Lilly
Nonclinical Road-map & Impacts on Implementation Susan DeHaven, Sanofi
Emerging Trends & Technologies Geoff Low, Medidata
Semantic Technology Tim Williams, UCB
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27th January 2016: PhUSE CS Working Groups
Marching to March 2016: 2016 CSS Agenda and Emerging Trends & Technologies Working Deliverable

Introduction & Welcome, CSS 2016 Agenda and Working Groups Overview Chris Decker, PhUSE FDA Liaison
Importance of the PhUSE Collaboration with the FDA Mitra Rocca, FDA
Experiences with Statistical Computing Environments Project Arthur Collins, Biogen
CDISC CFAST Update and 'Making Content More Accessible' Diane Wold, CDISC
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8th December 2015: PhUSE CS Working Groups
Marching to March 2016: Previewing the 2016 CSS FDA Sessions & New 'Semantics 101 for Pharma' Workshop

Introduction & Welcome and 2015 PhUSE CS Working Group Accomplishments Scott Bahlavooni, d-Wise
Common Errors in Loading SDTM Data to the FDA Repository Crystal Allard, FDA
Semantics 101 for Pharma workshop overview Tim Williams, UCB
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5th November 2015: PhUSE CS Working Groups
Marching to March 2016: 2016 CSS Registration Opens

Introduction & Welcome Scott Bahlavooni, d-Wise
2016 CSS Preview & CS Working Groups: Solutions Through Collaboration Chris Decker, PhUSE FDA Liaison
Best Practices for Managing Changes to Standards Scott Bahlavooni, d-Wise
(on behalf of DJ Chhatre)
Evaluating Alternative Transport Formats & Use Cases for Linked Data Scott Bahlavooni, d-Wise
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15th September 2015: PhUSE CS Working Groups
Marching to March 2016: Preparations for the 2016 CSS

Introduction & Welcome Chris Decker, PhUSE FDA Liaison
Standard Scripts for Analysis & Reporting Mary Nilsson, Eli Lilly
Semantic Technology Frederik Malfait, IMOS Consulting
Optimising the Use of Data Standards DJ Chhatre, Gilead
Non Clinical Susan DeHaven, Sanofi
Emerging Trends & Technologies Geoff Low, Medidata
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11th June 2015: PhUSE CS Working Groups: ­ The PhUSE Computational Science Collaboration Deliverables and the FDA

Introduction & Welcome Scott Bahlavooni, Biogen
FDA PhUSE Users Group Crystal Allard, CDER/CSC
JumpStart SDRG Findings Jeno Pizarro, Senior JumpStart Analyst
Study Data Standardization Plan Jane Lozano, Lilly
Non­Clinical Study Data Reviewer's Guide Sue Dehaven, Sanofi
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21st April 2015: PhUSE 2015 Computational Science Symposium
Debrief Webinar

Introductory Remarks & PhUSE 2015 CSS Debrief Chris Decker, PhUSE FDA Liaison
Working Group Updates, 2015 and Beyond:  
Emerging Trends and Technology Geoff Low, Medidata
Non-Clinical Roadmap and Impacts on Implementation Susan Dehaven, Sanofi
Optimizing the Use of Data Standards DJ Chhatre, Booz Allen Hamilton
Standard Scripts for Analysis and Reporting Hanming Tu, Accenture
Semantic Technology Scott Bahlavooni, Biogen Idec

18th February 2015: 2015 Computational Science Symposium:
Address Unmet Computational Science Needs

2015 CSS Working Group Breakout Sessions:
  • Non-Clinical Roadmap & Impacts on Implementation - 00.11.58
  • Emerging Trends & Technologies - 00.19.30
  • Optimizing the Use of Data Standards - 00.26.17
  • Semantic Technology - 00.36.26
  • Development of Standard Scripts for Analysis & Programing - 00.51.31
Chris Decker, PhUSE FDA Liaison

PhUSE CS Working Group Co-Leads
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8th January 2015
Introductory Remarks- 00.01.00 Chris Decker, d-Wise & PhUSE FDA Liaison Director
Opportunities for Collaboration - 00.15.57 Timothy Kropp, Associate Director for Innovation, Office of Computational Science, CDER, FDA
Development of Standard Scripts for Analysis and Programming - White Papers for Standard Analyses and Displays for Common Data Elements such as Demographics, Adverse Events, Disposition, Laboratory Measures, etc.- 00.32.10 Mary Nilsson, Eli Lilly
Development of Standard Scripts for Analysis and Programming - PhUSE Script Repository and Scriptathon Updates - 00.39.09 Hanming Tu, Accenture
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19th November 2014

Introduction - 00.01.10 Chris Decker, d-Wise & PhUSE FDA Liaison Director
JumpStart: Enhancing the Efficiency of CDER's New Drug Development and Review Process - 00:10:23 Lilliam Rosario,Director of the Office of Computational Science, Office of Translational Medicine, CDER, FDA
Optimising the Use of Data Standards: Best Practices for Data Standards Implementation - Assigning VISITNUM and EPOCH - 00:44:30 Trevor Mankus, Sr. Statistical Programmer, Shire
Q&A - 01.10.00  
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Q&A that could not be addressed during the webinar
can be accessed here

11th September 2014

 

Introduction - 00:01:13 Chris Decker, d-Wise & PhUSE FDA Liaison Director
Optimising the Use of Data Standards: Analysis Data Reviewer's Guide - 00.09.23 Susan Kenny, Biostatistician, Independent Consultant
Non-Clinical Roadmap and Impacts on Implementation: SEND Implementation Wiki/Forum - 00.31.04 Troy Smyrnios, Information Architect, Zoetis
Semantic Technology - Representing a Protocol in RDF - 00.43.08 Geoff Low, Lead Systems Architect, Medidata
Closing Remarks - 01:06.24 Chris Decker, d-Wise & PhUSE FDA Liaison Director
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