2017 Past Webinars

PresentationPresenter

29th November: Marching to March CSS 2018 & Working Group Projects

 
What's Happening at PhUSE & Marching to March CSS 2018 Scott Bahlavooni, Working Groups Director 
Optimizing Data Standards Working Group: GDPR Impact on Data Collection Sara Pauwels, Janssen R&D
Emerging Trends & Technology Working Group: ODM4 Submissions Nate Blevins, GSK
Emerging Trends & Technology Working Group: Statistical Computing Environments (SCE)  Shital Desai, Teradata
Optimizing Data Standards Working Group: SDSP Update Jane Lozano, Eli Lilly
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25th October: Look Ahead to 2018 US Connect & CSS and 2017 Annual Conference Review

 
Welcome & PhUSE Board Update Chris Hurley, PhUSE Americas Director
2018 US Connect Raleigh NC Jim Johnson, US Connect Chair
2017 Annual Conference, Edinburgh Review Jules van der Zalm, Conference Chair
2018 EU Connect Frankfurt Michael Harris, EU Connect Co-Chair
2018 CSS Silver Spring & KPI Project Update Chris Price, PhUSE Working Groups Director
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27th September: PhUSE/CDISC Collaboration & Project Updates

 
Welcome & What's Happening at PhUSE?  Yvonne Moores, PhUSE Strategy & Innovation Director
PhUSE/CDISC Partnership  David R. Bobbitt, CEO, CDISC
Key Performance Indicators (KPI) & Metrics Update Yvonne Moores, KPI Project Lead
SDTM ADaM Implementation Project Bhavin Busa & Mat Bryant, Project Leads
CSS Discussion Club: Annual Conference Scott Bahlavooni, PhUSE Working Groups Director
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23rd August: PhUSE News & Project Updates

 
Welcome & What's Happening at PhUSE Sascha Ahrweiler, PhUSE Communications Director
Management Stream: Annual Conference 2017 Sam Warden, d-Wise & Jasmine Kestemont, Innovion
Blockchain Technology: Emerging Trends & Technology Working Group Disa Lee Choun, UCB
                                          View the webinar recording  

28th June: Review & Feedback from the 2017 EU CSS

 
Review of the EU CSS 2017 Event Gitte Frausing, EU CSS Conference Chair
Data Transparency Lukasz Kniola, Biogen
SDTM & ADaM Implementation FAQ Chris Price, Roche
Nonclinical Topics Jaga Virayah, Bayer
Modeling Endpoints Mike Wasko, PDS LifeSciences
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24th May: Look Ahead to the 2017 EU CSS

 
Welcome & Overview EU CSS 2017 Scott Bahlavooni, d-Wise
Data Transparency Lukasz Kniola, Biogen
Nonclinical Topics Jaga Virayah, Bayer
Emerging Trends & Technologies: FHIR Project Trisha Simpson, UCB
Optimizing the Use of Data Standards: SDTM/ADaM Implementation FAQ Scott Bahlavooni, d-Wise
Standard Analyses & Code Sharing Shafi Chowdhury, Shafi Consultancy
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26th April: Review of Computational Science Symposium 2017

 
Welcome & Overview CSS 2017 Chris Decker, d-Wise
Standard Analyses & Code Sharing Working Group Hanming Tu, Accenture
Optimizing the Use of Data Standards Working Group Jane Lozano, Eli Lilly
Linked Data & Graph Databases Working Group Scott Bahlavooni, d-Wise
Emerging Trends & Technologies Working Group Ian Fleming, d-Wise
Nonclinical Topics Working Group Patricia Brundage, FDA
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29th March: Overview of Edinburgh 2017 Annual Conference

 
Welcome & Overview of Edinburgh 2017 Jules van der Zalm, Conference Chair
Real-world Evidence Stream Kriss Harris, SAS Specialists
Data Standards & Governance Stream Michael Knoessl, Boehringer Ingelheim
Posters Stream Jinesh Patel, Independent Consultant
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22nd February: CS Working Group Projects & Collaborations

 
CSS 2017 Preview Chris Decker, d-Wise
Evaluating the Use of FHIR in Clinical Studies Geoff Low, Medidata
Cloud Adoption in the Life Sciences Industry Anders Vidstrup, NNIT
EU 2017 Computational Science Symposium Gitte Frausing, Data Standards Decisions
FDA/PhUSE Collaboration Steve Wilson, FDA
                                                     Download the recording   

25th January: Marching to March CSS 2017: Working Group Projects

 
Emerging Trends & Technologies Working Group Geoff Low, Medidata
Nonclinical Topics Working Group Susan DeHaven, Sanofi
Optimizing the Use of Data Standards Working Group - NO SLIDES Jane Lozano, Eli Lilly
Linked Data & Graph Databases Working Group Tim Williams, UCB
Standard Analyses & Code Sharing Working Group Mary Nilsson, Eli Lilly
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11th January: Marching to March CSS 2017

Marching to March: CSS 2017 Overview Chris Decker, d-Wise
CSS 2017 Linkathon Scott Bahlavooni, d-Wise
Study Data Standardization Plan Jane Lozano, Eli Lilly
Deliverables Under FDA Review Crystal Allard, FDA
PhUSE US Update Chris Hurley, MMS Holdings
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2014 - 2016 Past Webinars

 

PresentationPresenter

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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