Update Nov Dec 2013 - (Page 14)

Enforcement Channel Bill Clinton's "man of the people" common touch to convey to your colleagues that you are their partner and share their goals. "I feel your pain," Clinton famously said. If you want your message to "speak to" your colleagues and regulators, you need to demonstrate that you understand the pressures they feel from having, for example, to meet a sales goal, obtain acceptance of a new drug application, or ensure that a new drug does what it is supposed to do. As Benjamin Franklin said, "Tell me and I forget. Teach me and I remember. Involve me and I learn." Involve yourself in your colleagues' professional lives, and the advice you give will not only be more customized to their particular needs, but your partners will be more likely to see its value and want to embrace it. Channel Teddy Roosevelt and "speak softly and carry a big stick." You want to be approachable, but you also want to ensure that your message is taken seriously. Hold people accountable, including yourself, for decisions. If you are asking others to be sincere and committed, you need to demonstrate the same characteristics. Enforcing your employees' adherence to regulations is what will garner your company credibility with the government. Presidential analogies may not speak to you. That is fine because what matters is that you discover what resonates with your business partners and help them discover what resonates with theirs. Just as each company has different risks, each company's employees may be receptive and responsive to different methods of articulating a message. Corporate SelfEnforcement through a Culture of Credibility and monitoring, even the extensive amount required by CIAs, is going to guarantee that every employee conducts himself appropriately in every communication he or she has every day. At a company with a culture of credibility, non-compliance is apparent and not tolerated because the culture is such that employees are committed to doing business the right way. The ability to self-enforce is clear, and sincerity is demonstrated in the decisions the company makes. The views expressed in the article are It is not possible for any drug company's compliance, legal, and regulatory departments alone, no matter how large, to ensure regulatory adherence by hundreds or thousands of employees. Companies can view the prospect of a government enforcement action resulting from alleged non-compliance in a number of ways, such as: (1) It is a cost of doing business. (2) Only literal adherence to the letter of the law is necessary. (3) Employees should use the compliance hotline instead of blowing the whistle. But no amount of corporate training solely those of the author and not necessarily those of Jazz Pharmaceuticals. 1. http://blogs.hbr.org/2011/03/culture-trumps-strategy-every/ 2. http://blogs.hbr.org/2011/03/culture-trumps-strategy-every/ 3. http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ 4. http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ 5. http://www.nytimes.com/2012/07/03/ business/glaxosmithkline-agreesto-pay-3-billion-in-fraud-settlement. html?pagewanted=all&_r=0 ENFORCEMENT, LITIGATION & COMPLIANCE REGIsTER NOw DECEMBER 10 - 11, 2013 | wAshINGTON, DC 14 Update Nov/Dec_MiniEnforcement.indd 1 November/December 2013 11/12/13 11:27 w w w . f d l i . o r g AM http://blogs.hbr.org/2011/03/culture-trumps-strategy-every/ http://blogs.hbr.org/2011/03/culture-trumps-strategy-every/ http://blogs.hbr.org/2011/03/culture-trumps-strategy-every/ http://blogs.hbr.org/2011/03/culture-trumps-strategy-every/ http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ http://www.executiveboard.com/legal-midsized-blog/how-culture-reduces-risk-by-the-numbers/ http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all&_r=0 http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all&_r=0 http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all&_r=0 http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all&_r=0 http://www.fdli.org

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Update Nov Dec 2013