Project ScopeThis 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. |
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| Project Leads | |
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Melvin Munsaka | |
Terry Walsh | |
Wendy Dobson (PHUSE Project Manager) |
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| New team formed and kick off meeting taken place. Presented at the recent CSS |
| Deliverables | Timelines |
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| Users Guide or White Paper | Q32021 |
| Project Members | Company |
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| Amelia Pang | Sanofi |
| Charles Beasley | MSN |
| Darshan Bhatt | Industry |
| Eileen Navarro Almario | FDA |
| Hongli Lu | Merck |
| John Marciank | AbbVie |
| Patrick Hannon | MMS |
| Paul Hayashi | A2 Healthcare |
| Preeti Venkataraman | FDA |
| Swarnalatha Reddy | Covance |
| Veronical Pei Yang | FDA |
| William Palo | AbbVie |