GSK Opens Vaccine Clinical Research Center in Hacettepe Teknokent
GlaxoSmithKline (GSK) has opened Turkey’s first Vaccine Clinical Research Center in cooperation with Hacettepe University Teknokent A.Ş. GSK Vaccine Clinical Research Center will facilitate participation to international clinical studies from Turkey, as well as realization of national research projects.
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New FDA safety website for drugs with no problems..
The US FDA opened a new website on 15 June that provides the public updated information on drug safety with a major difference: unlike other FDA safety notification systems, this one spotlights not only reasons for caution, but also the far more frequent instances when a new drug has been found to have no unexpected safety concerns. The site is designed to be accessed by the general public as well as healthcare professionals.
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EC proposal on new clinical trial rules not expected until late 2011 ..
The European Commission says that the consultation exercise on the review of the EU clinical trials directive has yielded some useful information on the shortcomings of the legislation and that it is now looking at the various policy options for tackling them.
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Transparency at the FDA..
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FDA started a new initiative to maintain a high level of transparency related to his regulatory affairs, inspections and other details.
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5 new guidelines..
The following guidelines are on now our webpages in English:
Guideline on Independent Data Monitoring Committees
Guidance on Observational Studies with Drugs
Guidance for the Preparation of Good Clinical Practice Inspection Reports
Guidance on the Format of Applications to the Ministry for a Clinical Trial
Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population
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The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe - Turkey
The European Forum for Good Clinical Practice (EFGCP) Report on Turkey can be found as an attached file..
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Know-how transfer from Turkey to UAE in clinical research
AkademiKA® as a continuous GCP training program that has reached 800 health personnel in Turkey since 2003, has accepted its first foreigner investigators to the programme in 2008 in Istanbul. In 2009, the success that AkademiKA® achieved abroad, turned into a special training demand from United Arab Emirates.
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MoH announcement about audits to CROs in Turkey
According to the recent announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site the Contract Research Organizations have to be audited by Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals in order to conduct clinical research activities in Turkey.
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MoH- E-applications to Clinical Research Department started
According to the announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site ; starting from April 15th, 2010 all applications should be made both by paper format and electronic format. All documents in the applications dossier will be uploaded to IEGM2007 system by Ministry of Health (MoH) General Directorate of Pharmaceuticals.
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Danish case handling times for clinical trials in 2010
Danish Medicines Agency must handle applications for authorisation of clinical trials within 30 working days. The chart shows the case handling times for applications received by the Danish Medicines Agency during each month of 2010.
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