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Project 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
Mary Nilsson nilsson_mary_e@lillyMac Gordon, Johnson & Johnson

rgordon2@its.jnj.com

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

nicky@phuse.global


FDA
Vaishali Popat

Status
colourBlue
titleCurrent Status
Q22022

New project for Q22022
Project Members Organisation 
Nhi Beasley FDA
Rebeka Revis IQVIA
Scott ProestelFDA

Q3 2024

  • Draft white paper reviewed by Team and PHUSE LT. Comments incorporated and now out for public review. Comments due 6 September.



Objectives & Deliverables Timelines
Complete White Paper final draft Q2 2023