Windhover Conferences - FDA/CMS Summit

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Early Bird Registration Ends September 30th!

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Cancellation Policy: The last day to cancel your registration for a refund, minus a $300 processing fee, is November 1, 2010. After that, you may send another delegate from your company.

Featuring the Special Keynote Addresses: FDA’s Public Health Priorities with

	Margaret Hamburg Commissioner Food & Drug Administration (FDA)
and Update from CDER with
	Janet Woodcock, MD Director, Center for Drug Evaluation & Research Food & Drug Administration (FDA)

2010 Speakers Include:
Andy Wyss Head Pharma North America President Novartis Pharmaceuticals Keynote	Robert Temple, MD Deputy Director, Clinical Science Center for Drug Evaluation & Research, FDA	Steven E. Nissen, MD, MACC Chairman of the Department of Cardiovascular Medicine The Cleveland Clinic	Robert Clark Vice President, Worldwide Regulatory Strategy Pfizer Inc.
Peter Honig Head, Global Regulatory Affairs AstraZeneca	Roger M. Perlmutter, MD, PhD Executive Vice President of Research & Development, Amgen Inc.	Gerald Dal Pan, MD Director, Office of Surveillance & Epidemiology Center for Drug Evaluation & Research FDA	Jonca Bull Vice President,US Drug Regulatory Affairs Novartis Head, FDA Liaison and Regulatory Policy Office

Landmark legislation will reshape the climate for biopharmaceutical companies.

What, again?

First the Medicare Modernization Act (2003) makes the federal government the dominant payor for pharmaceuticals, then the FDA Amendments Act (2007) redefines the regulatory model. Now, comes the Affordable Care Act (2010)—the most dramatic, system-wide change in the US health care sector ever. What will these changes mean for biopharmaceutical companies? Come to the FDA/CMS Summit to find out.

Health Care Reform: What’s Next?

Hear directly from leaders in government and industry about how health care reform will affect your business, How will development programs have to change to satisfy demands for comparative research? What pricing and reimbursement models will best position you for success? And where are the real opportunities for growth as the US healthcare market continues to evolve?

Last year’s conference was standing room only! Register now to reserve your seat.

If you make FDA/CMS Summit an annual must-attend like hundreds of other pharmaceutical and biotech leaders, keep ahead of the curve and mark your calendars NOW.

NEW for 2010! Hear the Regulators’ First-Hand Perspectives on:

Health Care Reform
New Drug Reviews
PDUFA V
Personalized Medicine
Comparative Effectiveness Research
Biosimilars/follow-on biologics
HCR Implementation
Payor Issues
Drug safety, risk management and post-market surveillance
Pharma marketing and promotions regulation and enforcement
Medicaid and Medicare reimbursement
Medicare Part D
Critical Path Initiative
Pricing Strategies

Key Benefits for Attending FDA/CMS Summit:

Hear about critical trends and changes so you can create successful strategies for dealing with FDA and CMS
Walk away with practical, real life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles
Get face-to-face access to the top regulatory thought leaders and policy makers
Benchmark your regulatory strategy against all the major pharmaceutical and biotech companies

Here is what your peers have to say about FDA/CMS Summit:

"I would like to thank the whole Windhover/RPM team for putting together this conference. Conferences are made by its participants and the group assembled here today is so diverse and truly experienced."
- Mark McClellan, MD/PhD, Former FDA Commissioner and CMS Administrator

"Summit provided a rare opportunity for a broad group of life science companies and regulators to interact in a frank, yet cooperative manner. Great opportunity to learn from peers and our FDA / CMS customer."
- David McNinch, Affymax, Sr. Director of Marketing

"Nobody does it better!!! Best healthcare business policy conference of the year."
- John Kamp, Executive Director, Coalition for Healthcare Communication

"Great speakers. Slides were well done - informative, not just fluff."

"Fostered networking times very useful."

"Excellent information from the best sources with regard to what to expect in Washington under the new Obama Administration."

"When the right people are invited as speakers, it makes for an exceptional conference."

"Excellent speakers, well-organized event and widely-attended."

"A very valuable conference, showcasing great insights into the framework of US regulatory bodies."

"All the up to date information on emerging trends in FDA and CMS policy presented in one place at one time by the people that make the policy."

"An important opportunity to step back and take an integrated look at the macro trends that will affect industry activity next year and beyond."

"From a European perspective and without being a regulatory expert, the summit certainly provided great insights into the current and future challenges related to FDA and CMS."

"I found the agenda to be comprehensive and balanced and was happy with the high caliber list of speakers."

"The agenda covered all the important background as well as "breaking news" in the key regulatory areas affecting our industry."

"The conference really showed that these two organizations have more in common than differences."

"The Summit was an impressive gathering of current and former FDA and CMS officials who provided valuable perspectives on policy slated for debate in 2006."

"Topics were of high relevance and speakers very impactful. A timely and informative conference."

"Valuable curriculum and great line-up of speakers. A great program for regulatory, government and marketing personnel."

A small sample of companies who send their teams to FDA/CMS Summit include:

Affymax, Inc.

Allergan, Inc.

Amgen Inc.

Amylin Pharmaceuticals, Inc.

AstraZeneca

Bayer Schering Pharma AG

Boehringer Ingelheim Corp.

Bristol-Myers Squibb Company

Cell Therapeutics Inc. (CTI)