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Project Scope

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 LeadsEmail

Melvin Munsaka  

melvin.munsaka@abbvie.com

Terry Walsh

terry.walsh@astellas.com

Paula Rowley (PHUSE Project Assistant)paula@phuse.global 


Status
colourBlue
titleCurrent Status
 Q22021

New team formed and are now aligned on objectives. They are started to draft their White Paper and is currently in progress. Due to availability of key members, progress has been slower than planned.
If you would like to join this project, email: workinggroups@phuse.global


Objectives & DeliverablesTimelines
Draft document for reviewQ32021
Users Guide or White PaperQ32021



Project MembersOrganisation
Amelia PangSanofi
Charles BeasleyMSN
Darshan Bhatt Industry 
Eileen Navarro AlmarioFDA
Hongli LuMerck
John MarciankAbbVie
Patrick HannonMMS 
Paul HayashiA2 Healthcare Corporation
Preeti VenkataramanFDA
Swarnalatha ReddyIndustry
Veronical Pei YangFDA
William Palo AbbVie
ShayamiEli Lilly