30th September 2020

15:00  (BST)            16:00  (DST)                10:00  (EDT)

Duration: 1 hour

Agenda to be confirmed

29th July – Webinar Recording

'CSS Overview and Working Groups Update'

Topic Speaker
Welcome and BoD Update

Yvonne Moores, GSK

Overview of the upcoming Virtual CSS   Chris Price, Roche and
Lilliam Rosario, Director of Office of Computational Science, CDER
Data Anonymisation and Risk Assessment Automation White Paper Lukasz Kniola, Biogen 
Data Transparency: A Global View of the Clinical Transparency Landscape – Best Practices Guide and White Paper Liz Roberts, UCB and
Anne Cutting, GSK

24th June – Webinar Recording

'PHUSE State of the Union'

Presentation Slides Speaker
An Update on All Things PHUSE Stephen Bamford, PHUSE Founder and Chairman of the Board

Topics covered:

  • COVID-19 update
  • PHUSE/FDA CSS 2020
  • PHUSE EU Connect 2020
  • PHUSE Event Planning for 2021
  • PHUSE Open Data Repository
  • Changes to PHUSE Membership
  • Q&A Session


27th May –
Webinar Recording

'PHUSE BoD, PHUSE CSS and Single Day Events go virtual and the Data Transparency Summer Meeting Overview'

Presentation Slides Speaker
Welcome and BoD Update Chris Price, Roche 
Best Practices for Quality Control & Validation Final White Paper Jane Marrer, Merck & Maria Dalton, GSK 
General Data Protection Regulation (GDPR) White Paper Arlene Coleman, Pfizer & Shannon Labout, Data Science Solutions
Clinical Trial Drug Safety Assessment for Studies & Submissions Impacted by COVID-19 Mary Nilsson, Eli Lilly
The Impacts of COVID-19 on Clinical Trial Transparency & Document Disclosure Nate Root, Ionis 


29th April – Webinar Recording

'PHUSE BoD, EU Connect Overview, PHUSE Single Day Events Go Virtual and Best Practice for Data Collection Instructions'

Presentation Slides Speaker
Welcome and BoD Update Beate Hientzsch, Mainanalytics
EU Connect Overview Anne-Sophie Bekx, 
PHUSE EU Connect Chair
PHUSE Single Day Events Go Virtual Chris Hurley, 
PHUSE Americas Director
Best Practice for Data Collection Instructions Aimee Basile, 
Surface Oncology &
Mary Nilsson, Eli Lilly

25th March – Webinar Recording

'PHUSE BoD and Working Groups Update' 

Presentation Slides Speaker
Welcome and BoD Update Sascha Ahrweiler, PHUSE Education Director
Recommendations for Anti-Drug Antibody (ADA) Modeling in SENDIG v3.0 and v3.1 White Paper Michael Wasko, PDS Life Sciences, Joleen White, Gates MRI, Gretchen Dean &
Leslie Lorello, Pfizer
New Project, Study Data Validation and Submission Conformance  Tim Williams, UCB


26th February – Webinar Recording

'US Connect Countdown, Leadership Stream Overview and Working Group Update' 

Presentation Slides Speaker
Welcome and BoD Update Chris Hurley,
PHUSE Americas Director
US Connect Countdown Mouly Satyavarapu, 
PHUSE US Connect Chair
US Connect Leadership Stream Guy Garrett,
Achieve Intelligence
Data Visualisation Subject Level Data Review Summary Report Eric Herbel,
Integrated Clinical Systems


22nd January – Webinar Recording

'US Connect Countdown, TCG updates and a Presentation from Novartis and Roche on FDA Real-time Oncology Review Pilot Programme'  

Presentation Slides Speaker
Welcome & PHUSE BoD Update Sangeeta Bhattacharya,
PHUSE Membership Director
US Connect Countdown Mouly Satyavarapu, 
PHUSE US Connect Chair
Lessons Learned from an FDA Real-time Oncology Review Pilot Programme: A Novartis & Roche Perspective Delphine Kerzerho, Novartis & Hiren Naygandhi, Roche
TCG Update on the Use of the Simplified ts.xpt File for Nonclinical Studies Patricia Brundage, FDA


If you would like to see past webinars, please click here.


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