Management of ODS Regulatory Referenced Deliverables
Project Scope |
|---|
The scope of this project is to identify a primary and back-up representative for each PHUSE regulatory referenced deliverable that will:
The project team will meet quarterly with the ODS Working Group Leads to discuss potential updates and their timing to avoid burdening the project team members and the regulatory authorities in reviewing the updated deliverables. |
Project Leads | |
|---|---|
Janet Low, Merk | |
Christine Rossin, Pfizer | |
Nicola Newton, PHUSE Project Coordinator |
Regulatory Referenced Deliverables | Representatives | |
|---|---|---|
Sumit Pradhan, Syneos Health
Pradnya Bharambe, Fortrea | ||
Dipen Kachhiapatel, Syndax
Mathura P Ramanathan | ||
Zhaojuan Meng, Sanofi
Suresh Yenishetty, IQVIA | ||
Christine Rossin, Pfizer
Kiran Kundarapu, Loxooncology | ||
icSDRG | Michael Wise, Edwards
Misty Michelle Odle, Eli Lilly | |
Venkat Rajesh Datla, Genmab Priyanka Pollarine, Biogen |