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About Dr. Seth Whitelaw

Dr. Seth Whitelaw

Dr. Seth Whitelaw

President & CEO

With more than 30 years working in the life sciences industry, Dr. Whitelaw started his career in life science compliance in 1993, when he became the Compliance Coordinator for C.R. Bard, Inc.  Present since the inception of life science compliance, his career has encompassed a wide variety of roles from in-house compliance officer with C.R. Bard, Inc., SmithKline Beecham NA, GlaxoSmithKline, and Misonix, Inc.,  to industry consultant with Deloitte and now his own firm, the Whitelaw Compliance Group.

A frequent author and speaker, he also serves as the editor of the Policy & Medicine Compliance Update (formerly the Life Science Compliance Update), and a law professor at Mitchell Hamline School of Law where he currently teaches students about health care compliance.

A graduate of Bowdoin College (A.B.), Washington & Lee Law School (J.D.), George Washington Law School (LL.M.) and Widener University School of Law (S.J.D.), Dr. Whitelaw also is a former Food and Drug Law Institute (FDLI) fellow, and worked as an intern for the FDA’s Office of Chief Counsel.

PUBLICATIONS

Whitelaw, et al., Drug Pricing – The Next Compliance Waterloo, 44 Mitchell Hamline L. Rev. (2018 Forthcoming). Available at SSRN: https://ssrn.com/abstract=3127733

Whitelaw, et al., A Bright Future or Unfulfilled Promise – An Update on Biosimilars and Their Prospects for Contributing to Meaningful Cost Reduction, Life Science Compliance Update, Vol. 4.3 (Mar. 2018).

“One Purpose to Rule Them All – A Resounding ‘Yes’ According to the District Court in U.S. ex rel. Cairns,” Life Science Compliance Update, Vol. 4.2 (Feb. 2018).

“On a Collision Course – FDA Clinical Investigator Disclosure and Open Payments,” Life Science Compliance Update, Vol. 2.9 (Sep. 2016).

“The Board of Directors’ Role in Pharmaceutical Compliance,” Pharmaceutical Compliance Monitor (Dec. 10, 2012).

“How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?”, Food and Drug Law Institute Policy Forum (Jun. 2011).

“Evaluating IRB’s and Their Roles,” 16 Food, Drug, Cosmetic and Medical Device Law Digest

“Proposition 65 v. Industry: David Against Goliath or a Misled Public Run Amok?,” 44 Food Drug Cosmetic Law Journal 677

 

REPRESENTATIVE SPEAKING ENGAGEMENTS

Guest lecturer at Temple University, Ursinus College and Medical Devices Section, Food and Drug Law, Rutgers-Camden Law School

Mitchell Hamline School of Law, National Speaker Series (Oct. 2016)

Mitchell Hamline’s Health Law Institute Symposium – Hot Topics in Healthcare Compliance (2018)

CBI 2nd Annual Drug Pricing Transparency Conference (2018)

CBI Annual Pharmaceutical Compliance Congress (multiple years)

Pharmaceutical Regulatory and Compliance Congress (multiple years)

Food and Drug Law Institute Advertising and Promotion Conference (multiple years)