Life Science Compliance Update



January 2018: Life Science Compliance Update

Written by , Posted in January 2018 LSC Update, This Month in Compliance

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The Monster in the Closet – New WHO Report Shines a Light on the Problem of Substandard & Falsified Medicines
By Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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The issue of substandard and counterfeit medicines has been known for some time. Since it is not often discussed openly, it is difficult to get an appreciation for the scope of the problem. However, a new WHO report, backed by four years’ worth of data, sheds some light on the matter and gives some guidance on how to identify likely problems and respond to them.

January 2018 Issue Summary

January 2018 LSCU Cover
Happy New Year everyone! As we start off 2018, we thought it was appropriate to think about New Year’s Resolutions, and so our feature article this month discusses the need to assess the company culture and possible ways to do it. Then in the spirit of holiday giving, we examine the 2017 OIG enforcement data to see what that bodes for 2018 and we see what the DOJ brought us in the form of a permanent FCPA Pilot Program. Finally, in keeping with the fact that life sciences is a global industry, we examine the new GPDR requirements in the EU, which are set to take effect in May 2018, as well as the unsettling WHO report on substandard and falsified medicines.


A Compliance New Year’s Resolution – Assess the Company’s Culture
Jenny McVey, Associate Director and Frances McLeod, Founding Partner, FRA
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The topic of ‘company culture’ is certainly not new, but it continually emerges as a hot topic within regulatory circles. An organization’s culture is recognized to exert a powerful influence on how a company and its people conduct business. Although there is an inherent understanding that by continually enhancing company culture, ethical aspects of the organization will follow suit, why isn’t culture reviewed with the same rigor and principles that are required for compliance programs? This article will discuss the importance to evaluate an organization’s culture of compliance, and will introduce some considerations on how this can be done.


Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up
Kristen Schwendinger, Senior Managing Consultant, Berkley Research Group
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As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018.


Christmas Comes Early – The FCPA Pilot Program Made Permanent
Jenny McVey, Associate Director, Forensic Risk Alliance
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When we first introduced the FCPA Pilot Program in the June 2016 issue, we noted the uncertainties of outcomes for companies who voluntarily self-disclose potential violations. On November 29, 2017, Deputy Attorney General Rod Rosenstein announced that the US Department of Justice (DOJ) had made the FCPA Pilot Program permanent. This article will review some of the key highlights outlined by the DOJ and some considerations for compliance professionals.


Privacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical Research
By Michelle Wilcox DeBarge, Partner, Wiggin and Dana LLP
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In May 2018, the new European Union (“EU”) General Data Protection Regulation (“GDPR”) will replace the familiar Data Protection Directive. In addition to significant new penalties, the GDPR requires companies to examine and rethink their data strategies, especially when working with clinical trials. This article discusses key considerations in implementing the GDPR for companies sponsoring and managing clinical trials.
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