Regulatory - Pharmaceutical Executive

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Regulatory
New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.

Sir Michael Rawlins: Regulation and Reputation

October 1, 2011

Sir Michael Rawlins, Chairman of the UK National Institute for Health and Clinical Excellence

Rebates and Reform

September 1, 2011

User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.

Congressional Investigations: What Every Exec Should Know

August 1, 2011

When faced with legislative scrutiny, be prepared, be truthful, and don't be afraid to say 'I don't know'...

The Supremes Shape Pharma

August 1, 2011

A number of important decisions from the Supreme Court will affect drug marketing, research, and regulation

Mind the Gap!

August 1, 2011

No one doubts the importance of health expenditures ? but then, euros, like dollars, don't grow on trees

Europe in HTA Gridlock

August 1, 2011

HTAs are gridlocked by diverse national requirements, a lack of alignment on processes, and even on the value of their outcomes.

Battles over Biosimilars

July 1, 2011

Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game

Optimizing your Value with Payers

June 1, 2011

Successful negotiations require a willingness to take risks and an ability to adapt

Educating Physicians

June 1, 2011

FDA's opiod REMS implies there is still value in industry-sponsored CME

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