Project Scope |
This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents. |
| Project Leads | |
|---|---|
Melvin Munsaka (, AbbVie) | |
Terry Walsh (, Astellas) | |
Nicola Newton (, PHUSE , Project Assistant) |
Objectives & Deliverables
Finalise stage 1 of draft White Paper for Public Review | Q2 2023 | |||||
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|---|---|---|---|---|---|---|
Working on a White Paper | ||||||
| Project Members | Organisation | |||||
| Amelia Pang | Sanofi | |||||
| Charles Beasley | MSN | |||||
| Darshan Bhatt | Industry | |||||
| Eileen Navarro Almario | FDA | |||||
| Hongli Lu | Merck | |||||
| John Landry | Eli Lilly | |||||
| John Marciank | AbbVie | |||||
| Patrick Hannon | MMS | |||||
| Paul Hayashi | A2 Healthcare Corporation | |||||
| Preeti Venkataraman | FDA | |||||
| Shayami | Eli Lilly | |||||
| Swarnalatha Reddy | Industry | |||||
| Veronical Pei Yang | FDA | William Palo | AbbVie||||
2024 | ||||||
|
Objectives & Deliverables | Timelines |
|---|---|
Finalise Stage 1 of draft White Paper | Q4 2023 |