Chief Compliance Officers

News & Analysis as of

The Writing's on the Wall: Wise Pharma Companies Will Heed FDA Warning in New Draft Guidance on Data Integrity cGMPs

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with CGMP that it was “troubl[ed]” by the growing number of such violations that...more

Supreme Court Sustains Protections for World Bank Information Sharing

On April 29, 2016, the Supreme Court of Canada ruled unanimously in World Bank Group v. Wallace that documents from World Bank Group investigations remain immune from document production requests that are part of domestic...more

Tribute to Dr. Jannetta and Improvisation in Compliance

It is rare you are able to write about someone who directly changed the quality of your life. Rarer yet that you did not know about him, only what he created, until you read his obituary. That happened to me recently when I...more

Who Can Fire a CCO?

There is something a little surreal when a CCO, while negotiating to join a company, raises the issue of his or her own termination. Not to be maudlin, but it is an important issue to consider....more

Shakespeare Week – Part III: Much Ado About Nothing and Incorporation of Social Media into Your Compliance Program

How does Shakespeare portend social media in the 21st century? I would submit that one only need look at Much Ado About Nothing to see how it should all play out. As with all Shakespeare’s plays there is quite a bit going on...more

Bank Culture in the Trenches

Institutional or corporate culture is much in the news lately, both inside and outside of banking. Amidst the uproar over Volkswagen's intentional compliance failure relating to emission standards, senior company management...more

Shakespeare Week – Part II: Henry V and Using Social Media in a Compliance Program

Most people remember the St. Crispin’s Day speech in Henry V as one of the greatest speeches in all of Shakespeare. However many people do not focus on what led to that speech which was that Henry went out among his troops,...more

SEC Affirms Sanctions on Stanford’s CCO

The SEC recently affirmed its ALJ’s ruling barring Alan Stanford’s former CCO from the industry and ordering monetary penalties of $260,000 together with $591,992 in disgorgement. The Commission held the CCO approved false...more

CCOs: Living in the Land of False Promises

We all have heard the scenario involving a compliance professional. A new CCO joins a company with promises from the board, the CEO and senior executives of cooperation, compensation and support for a robust independent...more

Corporate and Financial Weekly Digest - Volume XI, Issue 16

SEC/CORPORATE SEC Releases Registration Fee Estimator On April 18, the Securities and Exchange Commission announced the release of an online tool that will assist companies in calculating registration fees relating to...more

Shakespeare Week – Part I: Henry IV, Part II – Lawyers and Compliance

What is the most famous line in Shakespeare about lawyers? That is an easy one because lawyer-haters across the world (and lawyer-lovers as well) know it – First thing we do is kill all the lawyers. It comes from Henry IV,...more

DLA Piper's 2016 Compliance & Risk Report: What CCOs need to know

With federal agencies turning up the heat and investigative and enforcement activities on the rise, 81 percent of compliance officers are increasingly apprehensive about their personal liability in situations of corporate...more

Big Data in a Best Practices Compliance Program, Part III-Visualization

Today I continue my exploration of big data in a best practices Foreign Corrupt Practices Act (FCPA) compliance program. Yesterday, I considered how you might use big data in a best practices compliance program. Today I want...more

Incident Management – The New Frontier

Compliance programs are required to create and manage case investigation systems to handle potential misconduct, investigate allegations of wrongdoing and then dispense discipline. Lessons learned from these investigations...more

Big Data in a Best Practices Compliance Program, Part II

Today I continue my exploration of big data in a best practices Foreign Corrupt Practices Act (FCPA) compliance program. Yesterday, I considered what big data is and some ways to think about it. Today I want to move into some...more

Bridging the Week - April 2016 #3

SEC Adopts Swaps Business Conduct Rules Different From Comparable CFTC Requirements: Last week the Securities and Exchange Commission adopted final rules imposing business conduct standards on registered security-based...more

Big Data in a Best Practices Compliance Program, Part I

I have founded several podcasts, one of which is Compliance into the Weeds, where Matt Kelly joins me each week take a deep dive into the weeds of a compliance related topic. As many of you know, Kelly is the former...more

Assess and enhance your compliance program in this time of elevated risks

Continuous changes in the healthcare industry are delivering exciting innovations and new opportunities, but they are also creating new threats. Healthcare organizations face changing operational and enforcement environments...more

New DOJ Guidance and FCPA Pilot Program – Part IV: Impact

This week I have been exploring the implications of the Department of Justice (DOJ) announcement last week of a new program Pilot Program around Foreign Corrupt Practices Act (FPCA) enforcement, together with the document,...more

New DOJ Guidance and FCPA Pilot Program – Part II: Cooperation

Today, I continue my exploration of the implications from the Department of Justice (DOJ) announcement last week of a new program around Foreign Corrupt Practices Act (FPCA) enforcement (herein “Pilot Program”)....more

New DOJ Guidance and FCPA Pilot Program, Part I-Introduction

Last week the Department of Justice (DOJ) held a Press Conference, open to all, led by Andrew Weissmann and Leslie Caldwell. At this Press Conference, they announced the culmination of several ongoing initiatives into a new...more

[Event] Tech Talk: Best Practices for Compliance & Ethics Leadership: Strategy, Data and Cultural Performance - April 27th,...

Please join us on April 27, for an afternoon with ethics & compliance executives from leading companies, assembled to share in an interactive dialogue on cutting-edge data, case studies, and new approaches to company culture...more

[Webinar] Hot Topics in Anti-Corruption Enforcement and Compliance - April 22nd, 12:00pm, EDT

The Center for Responsible Enterprise And Trade (CREATe.org) and Transparency International-USA (TI-USA), cordially invite you to join us for a briefing to discuss hot topics in international anti-corruption compliance and...more

[Event] Tech Talk: How Better Reporting Changes the Game for Compliance - April 19th, 12:00 p.m., Philadelphia

The role of the compliance executive is changing before our eyes. With more resources and greater access to the CEO and Board, there’s more impetus than ever before for compliance executives to demonstrate and bolster the...more

Your Company’s Compliance Program is Finished – April Fool's

Happy April Fool’s Day! Could you ever imagine coming to work one day and realizing that you have “finished” your ethics and compliance program? There is nothing left to do. You can go home. Ohhhh, if only it was so....more

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