A Great Resource: The European Medicines Agency’s FAQ Site

10/06/2020

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Have you visited the European Medicines Agency’s (EMA) Frequently Asked Questions (FAQ) page?  It is a valuable resource for sponsors and CROs participating in global trials in reference to Good Clinical Practice (GCP) in the context of the 28 countries of the European Union.

On this site, the EMA has published answers to the most frequently asked questions it has received and organized them into 11 categories. Those categories are:

  • Questions about the Agency

  • Questions about the website

  • Questions about medicines

  • Questions about the evaluation of other substances

  • Questions about conflicts of interest and transparency

  • Questions about the availability of medicines

  • Questions about pricing, advertising, sales and patents

  • Questions about medical advice

  • Questions about clinical trials

  • Questions about fees

  • Translations

In the final category, Translations, the entire contents of the FAQ page are available in 22 European Union languages to download as PDFs. There is also a section to submit a question to the EMA if you are unable to find an answer to your question on the site.

In Part Two of this blog, we will look at new changes to the EMA’s Good Clinical Practice (GCP) FAQ page in regard to the recently released guidance concerning validation and qualification of computerized systems and how this relates to electronic sources such as electronic trial master files (e-TMFs) and study subject medical records.

-The Clinical Pathways Team

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