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QA Society letter |
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zondag, 02 december 2012 16:40 |
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30th November 2012
First European QA Conference 2013
Following discussions between BARQA, DGGF and SoFAQ on the feasibility and benefits of holding a European QA Conference it has been agreed, by all three Boards, to hold the first European QA Conference in 2013 and every three years thereafter.
The aim is to have a full European QA Conference involving European regulatory authorities and European QA Societies. The conference will consist of plenary, parallel and workshop sessions together with a large exhibition and poster area.
There is currently no major European QA Conference, so this is an opportunity for all European QA Societies to join together to promote a European QA Conference to share experiences, consider regulatory and guidance updates, to exchange information and experiences and hear from the European regulators.
The first European QA Conference will take place 25th-27th September 2013 at the Maritim Hotel, Bonn, Germany. Subsequent conferences will take place in the spring time allowing BARQA, DGGF and SoFAQ to hold their own national conferences later in the year as is currently the case.
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Laatst aangepast op vrijdag, 19 april 2013 15:18 |
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Lees meer...
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NVFG Jaarcongres 2013 |
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vrijdag, 19 april 2013 15:09 |
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UITNODIGING
NVFG Jaarcongres 2013
Na het zeer succesvolle lustrumcongres van 2012 hebben wij het genoegen u uit te nodigen voor het 2e NVFG jaarcongres dat gehouden wordt op
28 mei 2013
in Bilderberg Résidence Groot Heideborgh te Garderen.
Het thema dit jaar is het actuele onderwerp:
“Ethiek in Onderzoek, Geneesmiddelen en kosten”
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Reflection paper on GCP compliance in relation to trial master files |
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dinsdag, 26 februari 2013 11:47 |
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Document Reference/Title:
EMA/INS/GCP/3636736/2012EMA/INS/GCP/636736/2012
Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials
For EQAC Review :
EQAC Internal Review Date: 27-Mar-2013
Submission Date: 30-Apr-2013
Review Template Used: Document Template
- This reflection paper has been prepared to bring together the requirements of EU legislation and guidance relating to the TMF. This is deemed necessary by the EU GCP IWG Inspectors due to the numerous questions asked by organisations in relation to the TMF (in particular eTMFs4) and also to the repeated inspection findings concerning the TMF that have been made. The reflection paper aims to set out the requirements for the TMF as covered in directives and guidance and to give recommendations to assist organisations in maintaining a TMF that facilitates trial management, GCP compliance and inspection. The paper also addresses archiving of the TMF, clarifying retention times and gives some recommendations regarding destruction of paper documentation.
The document can be seen at the following link: here
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Comments should be provided using this template. The completed comments form should be sent to
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For any queries or responses please e-mail:
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If you have any problems accessing the information, please contact me.
Kind Regards,
Martha Byrne
(On behalf of EQAC)
These documents are circulated to EQAC members as part of you responsibilities for review and comment. Please ensure you notify your QA societies and comment on any aspects pertinent to your expertise.
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Laatst aangepast op dinsdag, 26 februari 2013 11:53 |
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