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 p

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.

FDA started a new initiative to maintain a high level of transparency related to his regulatory affairs, inspections and other details.

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

The European Forum for Good Clinical Practice (EFGCP) Report on Turkey can be found as an attached file..

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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