Topic: Regulatory Intelligence Working Group Monthly Meeting

Time: 13 April 2021 12 Noon Eastern Time (US and Canada)

Preparing Successful Health Authority Meetings

In his talk, Dr. Vivion will focus on principles and practices in preparing for successful meetings with health authority review teams. In his work with teams, he sees three areas where development teams frequently let weak communication interfere with good data: communication without a clear purpose, understanding what review teams want and need, inadequate communication skills.

Data never speaks for itself. We are its voice. As such, it’s imperative we know what it can and cannot say. Good preparation for health authority meetings begins with a thorough discussion and capture of the product’s messages, including both claims and interpretations and the issues that might stand as obstacles to a successful meeting and ultimately for approval. Teams need next to identify the data that the review team might need and want, and then exclude the unnecessary. Finally, teams need to ensure that the voices they use in their written and oral communication ring with professionalism and credibility. Dr. Vivion will discuss his experiences helping teams accomplish their goals.

The Presenter:

Michael J. Vivion, PhD, Vivion Communication

Dr. Vivion began his focus on communication while serving as an English professor and the Director of Writing at the University of Missouri in Kansas City. He left academia to work as a communication consultant in the pharmaceutical industry. Based in Basel, first as a consultant and then as the Global Head of Regulatory Communication, he helped drug development teams prepare persuasive documents and presentations for health authorities in the EU, the US, Japan, and China. During this time, he worked with a team hired by the FDA to assess FDA application reviews based on a set of document standards developed specifically for the pharmaceutical industry. After leaving Basel, he returned to consulting as a member of ECG Healthcare, focusing on preparing teams for FDA advisory committees meetings and EMEA Oral Explanations as well as key meetings with review teams. He currently conducts virtual workshops on written and oral communications for companies around the globe – and is waiting for the day when he will be doing them face to face.

Time: April 13, 2021 12:00 PM Eastern Time (US and Canada)

RI WG Monthly Meeting

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