Project Scope |
Best Practices in Data Standards Implementation Governance will cover the following areas:
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| Project Leads | |||
| Ellen Asam | (Merk), Merck | ellen_asam@merck.com | |
| Sandy VanPelt Nguyen | (, Pfizer | )||
| Nicola Newton, PHUSE Project Assistant | )katie@phuse | ||
| Objectives & Deliverables | Timelines | ||
Survey | Q1 2022 | ||
| Summarise survey results in a White Paper | Q2/3 2022 | ||
| Poster at PHUSE/FDA CSS | Q3 2022 | ||
| Publish White Paper | Q1 2023 | ||
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| Torsten Petsching | Boehringer Ingelheim
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| Project Members | Organisation | ||||||
| Aatiya Zaidi | Gilead | ||||||
| Aimee Basile | Surface Oncology | ||||||
| Brook (Amanda) Hinkson | Merck | ||||||
| Carlo Radovsky | Nurocor | ||||||
| Cathy Yang | Roche | ||||||
| Gayathri Mahadevan | Astrazeneca | ||||||
| Gina Wood | eClinical Solutions | ||||||
| Jennifer Jarvis | Eli Lilly | ||||||
| Jennifer Manzi | Pinnacle 21 | ||||||
| Junying Zhang | Gilead | ||||||
| Kapil Anand | Parexel | ||||||
| Kishore Pothuri | Vita Data Sciences | ||||||
| Ligia Kilinski Cevasco | Jazz Pharmaceuticals | ||||||
| Matt Baldwin | Amgen | ||||||
| Nicholas Pemble | Johnson & Johnson | ||||||
| Parisa Osivand Pour | Industry | ||||||
| Priyanka Pollarine | Biogen | ||||||
| Ramaiah Muvvala | Inductive Quotient | ||||||
| Ranvir Singh | Labcorp | ||||||
| Rie Ichihashi | Sanofi | ||||||
| Rony Ye | EBSI | ||||||
| Sathesh Avvaru | PPD | ||||||
| Susan Takas | Johnson & Johnson | ||||||
| Tingting Tian | Regeneron | ||||||
| Titania Dumas-Roberson | Unither Pharmaceuticals | ||||||
| Todd Bazin | Biogen | ||||||
Q4 2024 | |||||||
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| Objectives & Deliverables | Timelines |
White Paper Published | Q4 2024 |
Publish White Paper | Q3 2024 |
| Potentially make updates to White Paper following PHUSE Steering Committee and Public Review feedback | Q3 2023 |