Compliance in the C-Suite - Pharmaceutical Executive


Compliance in the C-Suite

Pharmaceutical Executive

Communication to assess risk

Companies must prioritize compliance functions based on budget and risk. Source: Cutting Edge Information
In addition to setting the tone on transparency and the importance of compliant business practices, top leadership also needs to be kept abreast of ever-emerging risk areas the company faces. This requires well-established lines of communication between the executive committee and the chief compliance officer. As the point person between business units and management, compliance officers must cast a wide net to capture information.

The OIG is clear about wanting top compliance officials in the C-suite. Source: Cutting Edge Information
To properly assess and prioritize risk, compliance officers and their teams need lots of friends across the company. "The compliance officer has to be in lockstep with medical affairs, to know what's coming out in the literature," says Bennett. "The minute there's a new paper that comes out—you can use this adult drug on a baby, for example—everybody is going to want to talk about it." Knowing about the shifting areas of risk, and adjusting the compliance program to account for them is crucial to preventing non-compliant activity. If a product-related issue is surfacing repeatedly through helpline calls, for example, compliance should know about it.

Creating processes to address and prioritize internal challenges is an important prophylactic for non-compliance. Source: Cutting Edge Information
Human resources is another important trove of information, and a necessary strategic partner for compliance personnel. "Sometimes a flurry of HR activity will happen in a facility or a work group where there is a compliance problem simmering at the bottom of it all," says Bennett. "I know one compliance officer that has a monthly coffee date with the head of HR, the head of audit, and the head of legal, and she sits down and they have coffee talk for 30 minutes. And you wouldn't believe the amount of good information she gets from that, and it helps with trend analysis."

Costopoulos says the head of HR at Eisai, who also sits on the executive committee, is a "very important relationship," in terms of promoting policy, and helping out on internal investigations and appropriate disciplinary measures. "All this boils down to holding employees accountable," says Costopoulos. "HR is interested in that, we're interested in fostering that, so I do tend to work very closely with our entire HR organization on a number of different projects."


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Source: Pharmaceutical Executive,
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