a shadow
Home  /  Member Log In

If you do not have an account you can register HERE for free.

Moderating Tips And The Art of and Lion Taming

August 14, 2017

My first time moderating an advisory board, I had the distinct feeling of being a lion tamer in a cage without a chair or whip for protection. The panel of 15 KOLs had three who loved the sound of their own voices and assumed everyone else would as well. Some other participants may have been shy – but almost all were unwilling to compete, disagree, or offer alternative opinions. I thought there had to be a better way of managing a group like this. Through talking to others who excel at moderating, some Internet research, and my own evolving experience, I have landed on these 10 tips as particularly useful.

Read More

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.

Read More

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.

Read More

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.

Read More

Sign up for Updates

Thank you for subscribing.

Sign Up For Updates

* required field

Thank you for subscribing.
X