Compliance: Not Just a US Issue

Posted 03 August 2015 | By Alan G. Minsk, JD 

“Compliance” might be one of the most frequently-used terms in the healthcare industry. Compliance covers so many things and, in fact, is not merely a US issue. Life science companies must ensure global compliance, and this collection of feature articles in Regulatory Focus exclusively for RAPS members only scratches the surface.

In “Regulatory Quality Compliance Programs for Drugs and Biologics in the US and Canada,” Ryan Thompson, Vadim Lysenko, Mukesh Kumar, Giri Venkiteela and Lewis Lau provide an overview of compliance activities here and in the Great White North, as well as useful tools to strengthen quality compliance programs. Judy Fox piques our interest by revealing the “Untold Compliance Story Behind Sunshine Data.” You’ll have to read Judy’s article to learn about some challenges in presenting accurate and complete data to comply with the Sunshine Act, while finding a balance to preserve the integrity of physician interactions.

Mike Burke discusses what life science companies need to know about the Foreign Corrupt Practices Act. He offers practical and effective compliance strategies to consider.

Kathryn Ronalds and Nancy Ruth help us understand Health Canada’s requirements that apply to reprocessors of single use medical devices to be regulated as manufacturers. They identify potential effects of this new initiative.

Finally, Brian Dahl focusses us on the “Evolution of Board Responsibility for Compliance Program Oversight.” He examines the Office of the Inspector General’s expectations and how these have changed over time, in a manner corresponding to Audit Committee requirements of Sarbanes-Oxley.

On behalf of the Board of Editors, we hope you find value in this collection of articles and you learn something. Enjoy!


Tags: compliance

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