This short course focuses on how best to plan, manage, prepare, and execute successfully at EU high-stakes meetings. A former CHMP member and a communication specialist will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with regulators. We will discuss how best to present your key massages and supporting slides and manuscript. This short course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these

At the conclusion of this short course, participants should be able to:

  • Summarize a high-level understanding of the EU regulatory system
  • Define a basic knowledge of the EU centralized procedure
  • Describe how best to prepare your team for an EU regulatory agency meeting
  • Recognize effective communication
  • Define an oral explanation, oral hearing, regulatory meetings, communication, and authority interaction.

Click here for additional information and registration details.

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