Reasons to attend
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.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
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