Project |
Across the Pharmaceutical Industry worldwide there is a variety of understanding of SEND and approaches to SEND implementation. Generally, the larger companies have had the resources to follow SEND through its first announcement to the issuance of the SEND Guidance document which set the due dates for SEND to be used for submission of the studies started on or after the due date.
This project creates an electronic survey sponsored by PHUSE, with up to 15 multiple choice questions and an option to provide additional free text information. The survey is sent out to PHUSE members, requesting a 30 day response time, then the responses are compiled, distributed and made publicly available.
Scope |
Execute an annual survey process to objectively collect data that enables detection of impactful issues and trends (both good and bad) that can be acted upon by the PHUSE community The survey will: Results of the survey will be presented at the PHUSE/FDA CSS. |
Project Leads | |
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Tania Smith, Covance | |
| Lindsy Eickhoff, BASinc | leickhoff@basinc.com |
| Alex Pearce, PHUSE Project Assistant |
Project Leads
Bob Friedman
Janice M Fiori
Lou Ann Kramer
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Key Milestones
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| Objectives & Deliverables | Timelines |
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Launch Survey | Q2 2023 |
| Present survey results in a poster at PHUSE/FDA CSS 2023 | Q3 2023 |