Policy & Medicine Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry. The Policy & Medicine Compliance Update offers practical insight into:
- False Claims Act and Qui Tam Developments
- Health Care Fraud Alerts and Enforcement Trends
- Corporate Integrity Agreements
- Physician Payments Sunshine Act
- FDA Guidance and Warning Letters
- International Regulations and Enforcement
- Best Practices For Compliance
Publisher
Thomas Sullivan
Thomas Sullivan is Editor of the popular website Policy and Medicine (www.policymed.com). Started in 2008 as a newsletter for his clients, Policy and Medicine has become compliance officers’ go-to publication for important regulatory and compliance issues affecting the pharmaceutical and device industry. For five years Policy and Medicine has been ranked first by Google as an information source for the Physician Payments Sunshine Act. Policy and Medicine has been quoted in the New York Times, Wall Street Journal, and CNN.com.
Tom has presented at many national meetings discussing regulatory and compliance issues including talks on the Physician Payments Sunshine Act, FDA Regulations, Affordable Care Act, legal cases and settlements, and prescription drug shortages.
As Publisher of Policy & Medicine Compliance Update, Tom will survey the industry to find what is important to keep your companies in compliance with international, federal, and state laws and regulations.
In 1995, Tom started Rockpointe Corporation to provide continuing medical education to physicians around the world. Rockpointe, and its ACCME-accredited subsidiary, Potomac Center for Medical Education (PCME), are among the nation’s leading medical education companies. He is also one of the co-founders of the CME Coalition, a lobbying organization for CME providers, which has been successful in educating stakeholders in Washington on the value of accredited CME.
Prior to founding Rockpointe, Mr. Sullivan was an award-winning television producer and political consultant. He provided services for the National Republican Congressional Committee and campaigns for Congress, Governor and US Senate. He began his career working on Capitol Hill and in the Florida Legislature.
Editor
Dr. Seth Whitelaw
Dr. Seth Whitelaw has more than 20 years of industry experience in the life sciences and healthcare sectors, as an attorney, compliance officer and consultant, Dr. Whitelaw has formed his own consulting firm, Whitelaw Compliance Group, dedicated to helping small to medium-sized FDA-regulated companies grow and achieve sustainable integrity.
His career has focused on food and drug law, and corporate governance, as well as designing and running corporate compliance programs within medical devices, pharmaceutical sales, and marketing and pharmaceutical R&D. He is a licensed food and drug attorney, with a doctorate in Health Law.
In his various roles, Dr. Whitelaw has worked for the FDA’s Office of Chief Counsel, participated in Corporate Integrity Agreement negotiations, and implemented three (3) successful corporate compliance programs in the fields of medical devices, pharmaceutical sales and marketing and pharmaceutical research and development. As a result, he has handled and overseen numerous internal fraud and FCPA investigations both domestically and internationally involving a variety of third parties including distributors, wholesalers, clinical trial sites, and individual physician practices. He also has conducted numerous compliance program and overall risk assessments.