Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


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 LeadsEmails
Mary Nilsson (Eli Lilly)

nilsson_mary_e@lilly.com

Greg Ball (Novavax)gball@novavax.com
Katie Warren (PHUSE Project Assistant)katie@phuse.global 


Objectives & Deliverables 
White Paper 
Journal Article 


Status
colourBlue
titleCurrent Status
Q2/3 2022

Project approved Q2 2022.



Project Members Organisation 
Barbara HendricksonAbbvie 
Brian Panik MedAssessment 
Charles BeasleyIndependent 
Clio WuChinook Therapeutics
Emily GorenSeagen 
Jyoti Agarwal Gilead
Hannah Palac AbbVie 
Karen WadeRhoworld
Ketan DurveJanssen Research & Development
Kimberly UmansBiogen
Mac Gordon Johnson & Jhonson 
Mengchun LiTB Alliance 

Mika Tsujimoto

Eli Lilly 
Nhi Beasley FDA
Peg Fletcher MedAssessment 
Pranav Soanker Pfizer 
Ramaiah MuvvalaInductive Quotient
Rebeka Revis IQVIA
Scott ProestelFDA
Shayami Thanabalasundrum Exelixis
Sunil Kumar ShantharajuBoehringer
Suwen LiRoche
William Palo Abbvie
Ying (Heather) HaoProthena 
Vaishali PopatFDA