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The ONLY conference where you can have face-to-face dialogue with top policy makers and executives on how to drive your pre- and post-regulatory approval and commercialization strategies.

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December 10-11, 2012
The Mayflower Renaissance
Washington, DC

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The FDA/CMS Summit for Biopharma Executives
Life After 2012


There has never been a year quite like 2012.

The Supreme Court will rule on health care reform this summer, and industry will either have to ramp up preparations for a massive expansion in the insurance market in 2014—or pick up the pieces if some or all of the law is voided.

The new rules for drug reviews will be enacted by Congress soon thereafter, with the reauthorization of the Prescription Drug User Fee Act and the creation of new generic drug and biosimilar user fee programs. Those programs will bring sweeping changes in the rules for success in drug development and life-cycle management—and the final law will likely include many add-ins that may be even more important to industry.

Last but not least, the voters will decide in November whether Barack Obama returns for a second term, or Mitt Romney takes over as President—and which party will be ascendant on Capitol Hill for the next two years. With deficit reduction sure to take center stage, biopharma companies will need to know who will be deciding what to cut—and how to make sure that the climate for innovation is protected.

That is an incredible series of unpredictable events. But one thing is certain: industry will need to adapt quickly to the new rules and new rule-makers.

Don't be caught unprepared. Join us at the eighth annual FDA/CMS Summit for Biopharma Executives.

 

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

View other testimonials »»

2011 Special Keynote Address Speakers:
Martin Mackay Martin Mackay
President
Research & Development
AstraZeneca Pharmaceuticals
Steven Spielberg Steven Spielberg
Deputy Commissioner for Medical Products & Tobacco
Food & Drug Administration (FDA)
Karen Midthun Karen Midthun, M.D.
Director Center for Biologics Evaluation and Research
Food & Drug Administration (FDA)

View Complete List of Speakers »»

 

 

Cancellation Policy: The last day to cancel your registration for a refund, minus a $300 processing fee, is November 1, 2012. After that, you may send another delegate from your company.