Thursday, July 10, 2008 • 12 PM ET / 9 AM PT • 90 minutes

About the event • Key topics • Benefits • Register

Featuring

D. Bruce Burlington MD
Independent consultant
Former Executive Vice President and Worldwide Head of Regulatory Affairs, Human Safety, & Quality, Wyeth
Former Head, Center for Devices and Radiological Health-U.S. Food & Drug Administration

John Dent
Former SVP, R&D Consumer Healthcare
GSK Consumer Healthcare

John Pinney
President
Pinney Associates

Cindy DiBiasi
Partner
3D Communications

Chris Walker
Executive Editor, Consumer Products Group
FDC Reports

REGISTER NOW

• Live webinar: $399
• Live webinar plus complete audio recording: $499
• Audio recording only: regular $399

Getting a drug or medical device to market has never been more expensive, time-consuming, or difficult. New legislation increases the likelihood that your product will wind up in front of an FDA advisory committee. With the road to approval becoming even tougher, just having solid data to support your product may not be enough.

Knowing how to avoid common pitfalls, effectively present your story to an increasingly skeptical audience, and manage Q&A can make or break your new drug or device application.

Experts agree that the advisory panel process itself has changed. Because of tighter conflict-of-interest rules, panelists tend to be less well-informed about your product and indication, and more concerned than ever about product safety. The combination makes for a particularly challenging meeting. But there are strategies and processes that can help you prepare your team, better explain the issues, and increase your chances for product approval.

We bring you seasoned veterans who have successfully steered Rx drugs and first-in-class switches through the approval process. Presenters include regulatory executives from pharmaceutical companies and communications and risk management experts.

In this webinar, these experts will take you through a strategic approach to preparing for an advisory committee that maximizes your chance of success, no matter your level of experience in this challenging process.

So join us, in the convenience of your own office, for a thought-provoking analysis of the issues central to your company's success. Gather your team (or several teams), a conference room at your office, a phone, and if possible, a computer with web access. No travel required!

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You’ll learn how to ...

• Adopt the critical strategies for success
• Avoid the common mistakes companies make
• Communicate most effectively with the FDA
• Build your presentation team
• Identify and prepare for critical issues early in the process
• Determine and write your product’s story
• Stay on message – while remaining flexible

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What does registration get me?

• One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
• One (1) password to a website on which you'll be taken through the presenter's slides as they speak to them.
• An interactive Q&A round with speakers: Type your questions on the website during the presentation, for the speakers to address afterward.
• Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
• The insight you've come to expect and respect from Windhover and our guest speakers.

What are the unique benefits of a webinar?

• Convenience – and lower cost.Your entire team can listen in one room. No travel required!
• A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
• Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference — via the web or by telephone, with complete anonymity.
• Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time!

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Register online: Click here for the live webinar

Register online: Click here for the live webinar PLUS recording

Buy the CD recording: Click here for just the recorded webinar

Register by email: ariley@windhover.com

Register by phone: Alexandria Riley / 203-838-4401, X113

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