The Road to FDA Approval: Advisory Committee Survival Strategies

(www.windhover.com)

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!