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The Danger of Company Groupthink in FDA Advisory Committee Preparations

June 6, 2017

It might seem obvious that one person alone cannot drive successful FDA advisory committee (ADCOM) preparations. What’s less obvious is that one unchallenged thought process could also result in failure. But that’s the unfortunate outcome of company groupthink.

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CHMP Meetings: How to Succeed

May 22, 2017

In our last blog, we focused on the non-transparent nature of CHMP meetings – and the challenges sponsors face in making sure that CHMP representatives understand and retain the presenters’ messages.

In this follow up article, we detail how to succeed given an often limited preparation timeline. It requires five key considerations.

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CHMP Meetings: A Rare Behind-the-Scenes Look at These Private European Regulatory Meetings

May 8, 2017

The first thing you need to know about CHMP meetings is that they are not public.

Because of this, you can’t research the meeting by watching a video online or reading a transcript. At the same time, these are extremely high-stakes meetings, where companies present their data and answer questions before a panel of individuals who will likely decide – or at least heavily influence – the future of the company’s product.

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Active Listening Can Make You a Better Speaker: Part 2

April 25, 2017

Have you ever heard that “God gave us one mouth and two ears for a reason, so we ought to listen twice as much as we speak”? The old Irish proverb holds true and is now backed up by science. In Part 1 of this blog series, we talked about how effective speakers set up their presentation to help foster active listening. In this blog, we will discuss how speakers can make sure that THEY are actively listening.

Using both ears is just the beginning.

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