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Scope

Project

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.


  


gball@novavax
Project LeadsEmails
Mac Gordon, Johnson & Johnson

rgordon2@its.jnj

Mary Nilsson 

nilsson_mary_e@lilly.com

Peg Fletcher, MedAssessmentpeg.fletcher@medassessmentGreg Ball .com
Objectives & Deliverables White Paper Journal Article 
Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


FDA

Status
colourBlue
titleCurrent Status
Q22022

New project for Q22022
Project Members Organisation 
Nhi Beasley FDA
Scott ProestelFDA
Vaishali Popat

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