Tuesday, April 14, 2009

CIS Gets Published!

"Organizing Your Commercial Compliance Programs"
(as published in Pharmaceutical Commerce on March 28, 2009)

By: Christopher Cobourn, CIS VP of Regulatory Compliance and Clarissa Crain, CIS Compliance Director
chriscobourn@cis-partners.com and clarissacrain@cis-partners.com

Two of CIS' finest were published in Pharmaceutical Commerce last month, and we are extremely proud! Their article "Organizing Your Commercial Compliance Programs" was published on March 28, 2009.

We are providing the article's intro on the PCB; for the entire article please see the following link: http://www.pharmaceuticalcommerce.com/frontEnd/1122-compliance_OIG_off_label_PhRMA_Coburn_Crain.html

Regulatory attention has intensified over commercial activities.
Here’s what to do to minimize risks and raise compliance levels:

The concept of Commercial Compliance in U.S. manufacturing has evolved
very quickly over the past 5 or 6 years, resulting in increased regulatory
requirements and investigation activity. While the security of the supply chain
and the ethical promotion of drugs has been a significant focus, recent
investigative trends show a shift in the government’s focus. Now, the federal
government and states are becoming increasingly interested in sales, marketing,
and distribution activities that ultimately affect the sales or prices witnessed
by the government. This has led to an increase in Federal False Claims Act
investigations and Off-Label Promotion investigations...

Congratulations Chris and Clarissa, keep up the good work!

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