Skip to end of metadata
-
Created by Former user, last modified by Former user on Oct 21, 2022
Go to start of metadata
You are viewing an old version of this page. View the current version.
Compare with Current
View Page History
« Previous
Version 31
Next »
Project Statement |
---|
Transparency initiatives allow public scrutiny and research in the application of new knowledge based on clinical data. Current GxP guidelines do not apply to transparency as it represents a different flow of data in which anonymisation is carried out on a copy of the regulated data. |
Project Statement |
---|
Transparency initiatives allow public scrutiny and research in the application of new knowledge based on clinical data. Current GxP guidelines do not apply to transparency as it represents a different flow of data in which anonymisation is carried out on a copy of the regulated data. |
Project Impact |
---|
Good Transparency Practices (GTP) would provide a means to achieving accountability and traceability while providing reasonable assurance that privacy requirements are being upheld. |
Objectives & Deliverables | Timelines |
---|
Good Transparency Practices guidance document | Q3 2022 |
|
---|
- Group are completing current background research and organising notes to prepare for writing the GTP guidance.
- Successfully solicited involvement from the EMA and Health Canada.
- Group are beginning the first draft of GTP guidance.
|
Project Members | Organisation |
---|
Abhinav Srivastva | Exelixis |
Andre Molgat | Health Canada |
Benjamin C Shim | Eli Lilly |
Brenda Tiffin | Claritidox |
Cara Campora | Beigene |
Devaki Thavarajah | Industry |
Dhiraj Dabhi | Eli Lilly |
Mahesh Swaminathan | Bristol Myers Squibb |
Manohara Basoor Halasiddappa | Algok Bio |
Mekhala Acharya | Takeda |
Sanjay Bagani | Xogene |
Sarah Balay | Privacy Analytics |
Sharon Niedecken | Pfizer |
Shannon Lefaivre | Roche |
Shweta Srivastava | Xogene |
Sophia Zilber | Pfizer |
Rama Empati | Astrazeneca |