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Project Scope

This project team will create a White Paper with recommendations for treatment emergent definitions, with a focus on Phase 2-4 clinical trials.  This White Paper will build upon a White Paper that outlines results from a survey on current practices, indicating variation that can likely be reduced.  Recommendations will be based on the desired end-in-mind, and may or may not be consistent with current practices

Project LeadsEmails
Mary Nilsson
nilsson_mary-e@lilly.com
William Palo
william.palo@abbvie.com
Wendy Dobson (PHUSE Project Manager)
wendy@phuse.eu
DeliverablesTimelines


Project MembersCompany
Alan ShapiroFDA
Beilei XuSanofi
Cathy BezekAstellas
Elisa YoungSouthernStarResearch
James GaiserPrometrika
Joanne ZhouGSK
Juan LiSanofi
Kim MusgraveAmgen
Lori Van MeterJNJ
Melvin MunsakaAbbvie
Nancy BruckenCSG-Inc
Pranab MitraIndustry
Ramaiah MuvvalaInductivequotient
Russell NewhouseLilly
Simin K BayganiLilly
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