Legal Compliance Essentials for Drug, Device, and Biotech Companies
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January 2-13, 2017
Online
2 J.D. credits
Approved for 15 on-demand standard CLE credits (event code: 227898)
Approved for 15 Regulatory Affairs Certification (RAC) Credits.
The Compliance Certification Board (CCB)® has approved this event for up to 10.8 CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this program content or of the program sponsor
Faculty
Dr. Seth Whitelaw, J.D., Founder, Whitelaw Compliance Group, LLCSenior Fellow and Adjunct Professor, Life Sciences Compliance
Description
The U.S. health care system is composed of three primary parts: providers, payers, and finally manufacturers (drug, device, and biotech companies). It is a complex, complicated, and challenging system of laws, regulations, cases, guidance and, in some cases, folklore. This course is designed for the current and future attorney or compliance professional supporting drug, device, and biotech companies. Students will gain a practical understanding of the laws, regulations, cases, and guidance they will encounter in daily practice. Also, upon completion, all participants will understand how to design and operate an effective company compliance program.
Textbook
O’Reilly, et. al, Food and Drug Administration, 4th ed. (can be accessed online via Westlaw)
Holland & Knight, Corporate Compliance Answer Book 2017, Practicing Law Institute
From Addiction to Zika: Current Issues in Public Health Law
January 2-13, 2017
Online
2 J.D. credits
Faculty
Jill Krueger, J.D. Northern Region Director, Network for Public Health Law
Description
This course explores public health law through the lens of current issues in population health. Prescription drug overdose and the zika virus have captured the attention of both policy-makers and the public, as have topics such as gun violence, obesity, access to care, vaccine refusal, medical marijuana, and smoking. We will examine the leading causes of preventable death, disease, and injury, both in and out of the spotlight. Students will analyze the underlying social, economic, and environmental factors that contribute to or detract from community health and well-being, as well as legal strategies to address those factors. In the process, the course introduces students to the fundamentals of public health law, including those constitutional, statutory, and administrative laws that empower or mandate government to act to advance community health and those that curtail governmental power to do so.
Textbook
Required: Readings will be made available either through a bound supplement for sale in the bookstore, or through links on Blackboard.
Recommended: Public Health Law: Power, Duty, Restraint (3rd edition), Lawrence O. Gostin and Lindsay F. Wiley
Register here