The Road to FDA Approval: Advisory Committee Survival Strategies

F-D-C Reports and Windhover Information proudly present:

The Road to FDA Approval:
Advisory Committee Survival Strategies

An FDC/Windhover Webinar / Thursday, July 10 / 12:00 pm ET / 9 am PT
90 minutes

Save $100 now through July 3

To Register Contact Alexandria Riley at Tel: +1 (203) 838-4401 x 113

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!

Featuring:

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 to get the Early Bird price! (through July 3)
To Register Contact Alexandria Riley at Tel: +1 (203) 838-4401 x 113

Live webinar: $299 (regular $399)
Live webinar plus complete audio recording: $399 (regular $499)
Audio recording only: $399 (regular $499)

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

To Register Contact Alexandria Riley at Tel: +1 (203) 838-4401 x 113