Difference between revisions of "Knowledge Repository"

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| Ashwini Weber || Participant || Amgen || ashwinic@amgen.com
| Ashwini Weber || Participant || Amgen || ashwinic@amgen.com
| Lily Chen || Particpant || Industry || lchenconsulting@gmail.com
| Lily Chen || Participant || Industry || lchenconsulting@gmail.com
| Roopali Lakhe || Participant || Bayer || Rooopali.Lakhe@bayer.com

Revision as of 06:02, 10 February 2020

Project Overview

Being a Statistical Programmer in the Pharmaceutical Industry is more than just knowing how to write programming code. Besides strong technical skills, such a role requires comprehensive understanding of the clinical development process, underlying regulations, industry standards and medical knowledge.

This Knowledge Repository aims to serve as a quick reference guide. This will be achieved by identifying and referring to already existing material, which will be organised in a user-friendly structure. The project will look to split into 8 different sub-groups:

  • Drug Development Process
  • Clinical Study Design and Conduct
  • Clinical Study Workflow
  • Clinical Documents
  • Regulatory Environment
  • Programming
  • Data Standards
  • Therapeutic Areas

Team meeting frequency across the sub-groups will be no more than 1 hour fortnightly, and no less than 1 hour monthly

Project members will be required to research and curate materials already published

Meeting agendas and minutes will be stored in the projects Teamwork area (access to project members only)

The Knowledge Repository section of the Education website will be maintained by admin volunteers and the Co-Leads. Any content for the website can be prepared by any member of the project and uploaded to our project space on Teamwork for review, before uploading to the Education Website by the admins and Co-Leads.

If you would like to join this project, please email wendy (at) phuse.eu

Project Leads

Beate Hientzsch Co-Lead PHUSE beate.hientzsch@phuse.eu
Brigitte Bernhoff Co-Lead UCB brigitte.bernhoff@ucb.com
Wendy Dobson Project Manager PHUSE wendy@phuse.eu

Project Members

Alfredo Rojas Participant Accenture alfredo.rojas@accenture.com
Mani Bakthavatsalam Participant Sarepta MBakthavatsalam@sarepta.com
Raghava Regulla Participant Bayer Raghava.Regulla@bayer.com
Sandra VanPeltNguyen Participant Pfizer Sandra.VanPeltNguyen@pfizer.com
Shalini Dwivedi Participant Kinapse shalini.dwivedi@kinapse.com
Zuzana Rehm Participant GSK Zuzana.x.rehm@gsk.com
Mekhala Acharya Participant Covance Mekhala.Acharya@covance.com
Murphy Wassereau Participant Industry wassereau@mail.com
Nina Reyes Participant Covance Nina.Reyes@covance.com
Faheeza Rangunwala Participant GCESolutions Faheeza.Rangunwala@GCESolutions.com
Ashwini Weber Participant Amgen ashwinic@amgen.com
Lily Chen Participant Industry lchenconsulting@gmail.com
Roopali Lakhe Participant Bayer Rooopali.Lakhe@bayer.com

Objectives and Timelines

Initialise Project September/October 2019
Webinar Presentation - Call for Volunteers October 2019
Kick Off November 2019
Build Team & Sub-teams December 2019
Populate Education Website (at least one sub-team content) March 2020