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How the New EU Clinical Trials Regulation is different to the old EU Directive (2001/20/EC)?

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Published - 04.Aug.2014

The answers from the successful webinar with one of Astra Nova’s experts

On the 13th July 2014 Astra Nova Ltd., the UK-based company dedicated on providing pharma training globally, has organized a webinar for all people from the pharma and clinical research industry, so they can get familiar with the new EU Clinical Trial Regulation and the difference in comparison to the old EU Directive(2001/20/EC). With the help of Mr. Harris, an expert with more than 15 years of progressive experience in the Biotech and Pharma Industry, we have helped professionals to learn how these changes will reflect their daily activities and eventually their business.  Some of the most discussed findings and differences within the 2-hour webinar were:

  • Leniency in enrollment of incapacitated subjects
  • Different reporting obligations for study sponsors (regarding study status)
  • More extensive application of “tacit agreement” by which approval is implicit even when no feedback is received on time.
  • Making study results available to the public (greater transparency)
  • New and faster approval timelines due to consolidated dossier (CTA) review.

 

During the Q&A session people were happy to ask their questions related to the material or just looking for advices about cases they have faced, especially when working with international regulations combining EU, FDA, MHRA and other requirements. As not all of the people, who requested the webinar, could attend on the first session, Astra Nova Ltd. is now organizing a second webinar on the same topic which will take place on 14th August (Thursday) at 3 pm BST. You can click here to see more information and contact us for group discounts or if you just want the recording of the webinar.

 

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