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Communicating with EU Regulators/Health Authorities: An Overview of Approach, Planning and Procedure – Webinar

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No sessions planned as this time, however if you are interested in taking this course please contact us at info@eccrt.com
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About this course

In an article by Matthias Hofer1 the authors note that during the period 2008 – 2012, 85% of applications compliant with ‘communications’ (scientific advice) were approved, whereas only 41% of non-compliant applications were approved – Suggesting that the chances of regulatory approval are doubled if communicated effectively, and hence, receive the right advice from the European Medicines Agency (EMA)/CHMP.  


During this webinar, the strategy behind effective communication with the EU Regulators will be discussed and shall provide a useful overview of how to Approach, Plan and use the Procedure to gain a successful outcome.1

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