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Scope

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

  

, AbbVie

melvin.munsaka@abbvie.com

Terry Walsh, Astellas

terry.walsh@astellas.com

Wendy Dobson (

Nicola Newton, PHUSE Project

Manager)

Assistant

wendy@phuse

nicky@phuse.

eu

global


Status
colourBlue
titleCurrent Status

 Q42020New team formed and kick off meeting taken place. Presented at the recent CSSDeliverablesTimelinesUsers Guide or White PaperQ32021Project MembersCompanyAmelia PangSanofiEileen Navarro AlmarioFDAJohn MarcianoAbbViePatrick HannonMMS Preeti VenkataramanFDASwarnalatha ReddyCovanceVeronical Pei YangFDA

Q2 2024

  • Completed incorporating the second round of comments from FDA reviewers.  
  • Will be routing the Stage 1 white paper for the PHUSE executive review and thereafter post for public review. 



Objectives & Deliverables

Timelines 

Finalise Stage 1 of draft White Paper

Q4 2023
William Palo AbbVie