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Basic information for International IITs
Created by: ihrig , generated 2009/03/20 , last changed: 2010/02/04
The collection will provide both general central (of European authorities and institutes) and country-specific information in terms of dossiers, formulars, lists/checklists, schedules, power-point-presentations and further more. The material is ordered by information in english (if available) first and secondly country-specific.The overall aim of the presented collection is to ease the process of initiating and conducting investigator-initiated-trials, resp. optimum-use-trials in the European LeukemiaNet.
Information
Impact assessment of the directive 2001/20/EC for stakeholders.
Deadline: January 08, 2010
The directive 2001/20/EC (Clinical-Trials-Directive on Good Clinical Practice) could be amended and the EC has started an impact assessment to evaluate the goals and functioning of the directive. Part of the assessment is a public consultation process, which was performed on behalf of the ELN and further EU projects and stakeholer groups. The commented paper presented here is clearly focusing on the poor situation of multinational therapy optimization trials (investigator-initiated trials) and highlighting necessary changes (see c).
You will find here the
a) link to the EC website with some general information on Directive General (DG) Enterprise and the directive and
b) direct link to the consultation paper
c) final statement of stakeholder (non-commercial sponsors) on behalf of the ELN.
The following link will also lead you to further commented papers. They will be made public available by DG enterprise and industry at their website.
Paper to comment
(133KB)Workshops of DG Research
EFGCP/ ICREL
Report (06/2009)
(2.1 MB)
Denmark:
Regulatory Requirements: Overview
France:
Regulatory requirements: Overview
Germany:
Regulatory requirements: Overview
Italy:
Regulatory requirements: Overview
Spain:
Regulatory requirements: Overview
Sweden:
Regulatory requirements: Overview
Contact
Contact person for general content
If you like to
- comment the general content of this part of the website,
- suggest specific content to the European and/or national issues,
- or name a national representative for your workpackage regarding the initiation and conduction of IITs
Contact person for German issues
If you have any questions or suggestions, for example a specific document should be listed in the document collection, please contact ihrig@med.uni-frankfurt.de.
Miscellaneous
The administration of the website has been started in february 2008 and is still under construction.
