Welcome to the Real World: Innovating in a Rapidly Changing Policy Climate
Post-marketing safety regulation. Comparative effectiveness research. FDA/CMS parallel reviews.
What do all these public policy buzzwords have in common? The need to understand--and influence--the impact of pharmaceuticals in actual practice, rather than in the pristine setting of clinical trials.
When it comes to new public policy ideas and new pharmaceutical products, the big test is always the same: what happens when you try something new in the real world? Whether it is years of carefully controlled clinical research or decades of public policy debate, no one can be sure what will happen when a new product enters the marketplace, or a new public policy idea becomes law.
This is the real world: Health care reform is law. Biosimilars are coming. A new user fee deal is pending. Federal budget deficits are overwhelming.
How will all these factors affect the reality of the pharmaceutical business in the years to come? Join us at the seventh annual FDA/CMS Summit for Biopharma Executives to find out.
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 2011! Hear the Regulators' First-Hand Perspectives on:
- New Drug Reviews
- Pre- and post-market review process
- Biosimilars/follow-on biologics
- "Real World" data sets
- Formulary Management
- ACOs
- Cancer Drug Coverage
- Health Care Reform
- PDUFA V
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- Comparative Effectiveness Research
- HCR Implementation
- Payor Issues
- Drug safety, risk management, & post-market surveillance
- Pharma marketing and promotions regulation and enforcement
- Medicaid and Medicare reimbursement
- Pricing Strategies
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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 »»