Keyword      Search in       

Contact
Imprint
Privacy Policy
Site Map

RSS Feed News. Your shopping cart.

Google gadget.

GMP News
01/06/2011
 

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

Related GMP News
16/05/2012Development and Manufacturing of APIs: Final ICH Q11 Document Published!
16/05/2012Which Information on Stability of Pharmaceutical Bulk Products is required in the Application Dossier?
16/05/2012EMA strengthens Oversight on Clinical Trials outside EU
16/05/2012EMA - Regulatory procedural Advice on similar biological medicines
09/05/2012The new EMA's eSubmission Gateway for Centralised Authorisations is released!