Tag Archives: compliance

Compliance Congress: Walking the Line

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.
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Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
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Putting a Price Tag on Compliance: Cheap Change or Big Bucks?

Compliance rules under the US Physician Payments Sunshine Act have been criticized for the excruciating level of detail demanded from individual company submissions.  But relatively little scrutiny has been accorded to another pressing question:  how much will all this new reporting cost?  The burden of compliance for not just this new law but in many […]
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Promotional Review Committees: Shire Sets the Standard on Achieving High Performing Teams

by Arthur Lazarus What does it take for internal Promotional Review Committees to function at their best and avoid costly mistakes to the company? A leading industry practitioner offers 15 tips for high performing teams. Arthur Lazarus, MD, MBA, Shire Pharmaceuticals 1. Find a common voice. Given the diverse training and background of individuals who […]
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The Curious Case Of AstraZeneca v. ACE

by Mike Kelly and Andrew Dupre Insurance contracts are a language game that must be played very carefully, as AstraZeneca learned. From 2003 to 2012, AstraZeneca Plc was locked in one of the largest mass tort litigations in the United States, defending its blockbuster second generation atypical antipsychotic product Seroquel from allegations of failure-to-warn of […]
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