AE Groupings in Safety (AEGiS)

AE Groupings in Safety (AEGiS)

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.

Project Leads

Emails

Project Leads

Emails

Mac Gordon, Johnson & Johnson

rgordon2@its.jnj.com

Peg Fletcher, MedAssessment

peg.fletcher@medassessment.com

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global

Current Status Q4 2024

Current Status Q4 2024

  • White Paper reviewed, comments incorporated, final version in publication.

Objectives & Deliverables 

Timelines

Objectives & Deliverables 

Timelines

White Paper Published 

Q4

Complete White Paper final draft 

Q2 2023