Image Modified
Project | ScopeScope |
This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents. |
Project Leads | Email |
---|
Melvin Munsaka |
Paula Rowley (Nicola Newton, PHUSE Project Assistant |
)paula@phuse
Status |
---|
colour | Blue |
---|
title | Current Status |
---|
|
|
---|
Q12021New team formed and are now aligned on objectives. They are started to draft their White Paper. Due to availability of key members, progress has been slower than planned.If you would like to join this project, email: workinggroups@phuse.global
|
---|
- FDA comments incorporated into the WP
|
Objectives & Deliverables |
---|
Timelines | Draft document for review | Q32021 |
Users Guide or White Paper | Q32021 |
Timelines |
---|
Finalise Stage 1 of draft White Paper | Q4 2023 |
Project Members | Organisation |
---|
Amelia Pang | Sanofi |
Charles Beasley | MSN |
Darshan Bhatt | Industry |
Eileen Navarro Almario | FDA |
Hongli Lu | Merck |
John Marciank | AbbVie |
Patrick Hannon | MMS |
Paul Hayashi | A2 Healthcare Corporation |
Preeti Venkataraman | FDA |
Swarnalatha Reddy | Industry |
Veronical Pei Yang | FDA |
William Palo | AbbVie