Regulatory - Pharmaceutical Executive


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

Compliance in the C-Suite

January 1, 2013

Compliance officers have risen into management's highest ranks, by choice in some organizations, and by government decree in others. Either way, their importance as a strategic partner can hardly be understated.

The Puzzle Master: EMA's Guido Rasi

December 1, 2012

Europe's chief regulator charts a strategy from many moving parts. Dr Guido Rasi talks to Pharm Exec's William Looney.

Germany's Price Reform Revolution

December 1, 2012

At two years and counting, what's the secret of success in negotiating pricing under the new AMNOG legislation?

OTC Crunch Time in California

November 1, 2012

Over-the-counter products face a new wave of regulation.

Budgets, Biosimilars, and Bad Ads

November 1, 2012

While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives, writes Jill Wechsler.

Richard Bergström — Europe's Medicine Man

October 1, 2012

The new head of EFPIA faces a Promethean challenge: selling the merits of costly science and innovation in an era of bristling competition, fiscal crisis, and declining demographics.

Patients Wade Into the Pricing Debate

September 1, 2012

Europe's fiscal crisis is becoming a new rallying cry for patient groups—but regional unity is still elusive.

The Endless Treadmill of End-of-Life Care

September 1, 2012

Bending the cost curve back to valuing the cycle of life.

Costs, Coverage, and Court Decisions

September 1, 2012

Its election season and drug pricing issues are once again front and center in the policy wars on managing the high cost of healthcare.


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