Project Scope
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Project Leads | |
Michael Walega (Bristol Myers Squibb) | michael.walega@bms.com |
Chris Wells (Roche) | chris.wells.cw1@roche.com |
Paula Rowley (PHUSE Project Assistant) |
Objectives & Deliverables | Timelines |
Release of draft White Paper | Q3 2022 |
CURRENT STATUS Q3/4 2022 |
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Project are working on draft white paper. |
Project Members | Organisation |
Alicja Mark | Genmab |
Andrew McGowan | RHO World |
Andrzej Kinasiewicz | AstraZeneca |
Anne Lawrence | AbbVie |
Ansalan Stewart | FDA |
Arati Todkar | TCS |
Barbara Seider | Zealand Pharma |
Chonna Campbell | Unither Pharmaceuticals |
Crupa Kurien | Pfizer |
Debra Jendrasek | DSI |
Heidi Hoffman | Genentech |
Jean Mulinde | FDA |
Julie Appel | Novo Nordisk |
Karen Bleich | FDA |
Kate Tomlinson | PRISM |
Katherine Taylor | Merck |
Kevin Douglass | DSI |
Linda Del Paggio | Genentech |
Lukasz Bojarski | AstraZeneca |
Lynne Cesario | Pfizer |
Mary Arnould | Astellas |
Project Members | Organisation |
Mireille Lovejoy | Roche |
Monika Moersch | Boehringer-Ingelheim |
Mukesh Babu | Industry |
Nathalie Van Borrendam | Janssen Research & Development |
Nick Wells | Syneos Health |
Paul Brown | Danish Medicines Agency |
Priti Gupta | Pfizer |
Shalaka Gadhave | TCS |
Sheetal Chandarana | Roche |
Steve Young | CluePoints |
Steven Gilbert | Pfizer |
Problem Statement QTLs - the role they play in defining quality within the QbD framework, their relationship to Critical to Quality factors, associated methodologies and the interpretation of them have not been fully defined in clinical development, in particular where early development/small studies, bio equivalence studies and complex designs are concerned. Problem Impact This will impact the whole clinical development process and allow the move away from perfection to a defined and achievable quality, from which continuous quality improvement can begin. |
Terminology Example:
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