EMA Report on Clinical Trials outside the EU

"The European Medicines Agency published a meeting report reflecting discussions and comments made on its draft reflection paper on ethical and good-clinical-practice (GCP) aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the European Medicines Agency.

The discussions took place during an international workshop held in September 2010.

The workshop, which brought together 140 European and international participants from 43 countries, represents part of the public consultation process on the reflection paper.

All comments received during the workshop and in writing as part of the public consultation are currently being reviewed before the final version of the reflection paper is agreed and published later this year.

The slides from the presentations given during the workshop are also available to download."

Source: EMA press release

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