Difference between revisions of "Policy, Guidance and Material Reviews"

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= Project Overview  =
 
= Project Overview  =
The PhUSE Data Transparency Working Group, as an active player in the field, reviews on regular basis a number of deliverables produced by other key stakeholders in the form of guidances, policies or articles. In particular, the PhUSE Data Transparency Working Group was invited to the EMA Policy 0070 Stakeholders meetings to comment on earlier version of the [https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication/support-industry/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data External Guidance].  
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The PHUSE Data Transparency Working Group, as an active player in the field, reviews on regular basis a number of deliverables produced by other key stakeholders in the form of guidances, policies or articles. In particular, the PHUSE Data Transparency Working Group was invited to the EMA Policy 0070 Stakeholders meetings to comment on earlier version of the [https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication/support-industry/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data External Guidance].  
  
 
In addition, the Working Group has had a collaboration with [http://www.transceleratebiopharmainc.com/initiatives/clinical-data-transparency/ TransCelerate] on the topic and the 2 organisations provided each other comments on respective deliverables.
 
In addition, the Working Group has had a collaboration with [http://www.transceleratebiopharmainc.com/initiatives/clinical-data-transparency/ TransCelerate] on the topic and the 2 organisations provided each other comments on respective deliverables.
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| '''Name''' || '''Role''' || '''Organization''' || '''Email'''  
 
| '''Name''' || '''Role''' || '''Organization''' || '''Email'''  
 
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|Jean-Marc Ferran||Project Lead || PhUSE|| jean-marc.ferran@phuse.eu
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|Jean-Marc Ferran||Project Lead || PHUSE|| jean-marc.ferran@phuse.eu
 
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= Project Updates =
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''Italic text''= Project Updates =
  
The PhUSE Data Transparency Working Group is always interested to review other organisations' deliverables. Please get in touch with Project Lead if you would like us to review or give input to your work.
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The PHUSE Data Transparency Working Group is always interested to review other organisations' deliverables. Please get in touch with Project Lead if you would like us to review or give input to your work.
  
 
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Latest revision as of 09:28, 10 October 2019


Project Overview

The PHUSE Data Transparency Working Group, as an active player in the field, reviews on regular basis a number of deliverables produced by other key stakeholders in the form of guidances, policies or articles. In particular, the PHUSE Data Transparency Working Group was invited to the EMA Policy 0070 Stakeholders meetings to comment on earlier version of the External Guidance.

In addition, the Working Group has had a collaboration with TransCelerate on the topic and the 2 organisations provided each other comments on respective deliverables.

The Working Group also provided comments to Health Canada on their respective policy and guidance that were available for public review. The Working Group had an opportunity to provide feedback to the Cochrane organisation on their paper 'Interim guidance on how to decide whether to include clinical study reports and other regulatory documents into Cochrane reviews'.

Project Leads & Members

For each deliverable to be reviewed, different working group members volunteer based on their interest. We do not try to align all the comments although all comments are discussed within the group of reviewers and we provide all comments that are received from different experts so that the authors can receive and assess different opinions.
Name Role Organization Email
Jean-Marc Ferran Project Lead PHUSE jean-marc.ferran@phuse.eu

Italic text= Project Updates =

The PHUSE Data Transparency Working Group is always interested to review other organisations' deliverables. Please get in touch with Project Lead if you would like us to review or give input to your work.


Project Activities

There are no current reviews taking place at the moment.

Deliverables

Papers