Life Science Compliance Update

March

2016

March 2016: Life Science Compliance Update

Written by , Posted in March 2016 LSC Update, This Month in Compliance

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March 2016 LSCU Cover

Issue Summary

This month Life Science Compliance Update focuses on the importance of compliance culture. First, we examine the difference between what current CIA’s require in compliance programs versus what the Ethics and Compliance Initiative’s Blue Ribbon Panel suggests. Tracey Keele from KPMG then explores whether improving culture will address the pharmaceutical industry’s image problem. Other highlights this month include an article by Huron’s Chris Cobourn on the recently finalized rule on Average Medicaid Price (“AMP”) calculations, and Kaitlin Fallon does a comparison review of some of the global codes of practices and ethics governing life sciences commercial operations.


Issue Articles

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Do Gold-Standard CIAs Get Blue Ribbon Approval?
Calisha D. Myers, Esq., Staff Writer
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A Prescription for Life Science’s Regulatory Woes
Tracey Keele, Partner, KPMG Risk Consulting
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The Black Hole – AMP as Viewed from A Pharmaceutical Manufacturer’s Compliance Office
Chris Cobourn, Managing Director, Huron Life Sciences
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One Code to Bind Them All – Doubtful
Kaitlin P. Fallon, Esq., Staff Writer for Life Science Compliance Update
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A Different Mindset – Challenges of Working in China
Kaitlin Fallon, Esq., Staff Writer for Life Science Compliance Update
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Be Careful What You Sign Up For – Implied Certification and the False Claims Act (FCA)
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Exploring Strange New Worlds – FDA’s 2016 Program Alignment and Strategic Priorities
Calisha D. Myers, Esq., Staff Writer – Life Science Compliance Update
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