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Project

Scope

Scope 

This project team will define best practices for ensuring that similar types of adverse events are considered together for purposes of safety analyses. This project will develop efficient standardised processes and analyses that can leverage new technologies.


  


Project LeadsEmails
Mary Nilsson nilsson_mary_e@lilly
Mac Gordon, Johnson & Johnson

rgordon2@its.jnj.com

Greg Ball 
Peg Fletcher, MedAssessmentpeg.fletcher@medassessment
gball@novavax
.com
Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


Status
colourBlue
titleCurrent Status

Q22022New project for Q22022

Q1 2024

  • Draft white paper is out for final project team review. Once incorporating these comments, it will then be sent for public review in early June. 



Objectives & Deliverables Timelines
Complete White Paper final draft Q2 2023
Project Members Organisation Nhi Beasley FDAScott ProestelFDAVaishali PopatFDA