Legal Compliance Essentials for Drug, Device, and Biotech Companies
January 2-13, 2017
2 J.D. credits
Approved for 15 on-demand standard CLE credits (event code: 227898)
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.
Dr. Seth Whitelaw, J.D., Founder, Whitelaw Compliance Group, LLC
Senior Fellow and Adjunct Professor, Life Sciences Compliance
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.
From Addiction to Zika: Current Issues in Public Health Law
January 2-13, 2017
2 J.D. credits
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.
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
These courses will be taught using Blackboard and administered asynchronously online. In accordance with ABA rules, law students are limited to four credits in online courses per term, and to no more than 12 total online credits towards their J.D. degree. Law students must have earned 28 credits before earning credit for online courses.
- Students must complete all class sessions and reading assignments.
- Degree-seeking students must submit a written paper or complete a final exam as specified in each course syllabus.
- Students may take one or more courses. No course requires a prerequisite.
- Law Students: Degree-seeking students currently enrolled in an ABA-accredited law school should complete Part A of the application form and return it with a letter from their school’s registrar reflecting their status as a student in good standing with permission to take the Mitchell Hamline course(s) as a visiting student. NOTE: Mitchell Hamline students do not need a letter of good standing from the registrar and should register via Agresso.
- Working Professionals: Working professionals may apply by completing Part B of the application form, which grants them special student status.
Please contact Kari McMartin (email@example.com) for tuition information.
Nonrefundable application deposit: $150 per course
The deposit will be deducted from the total tuition amount and only returned if you are not accepted into the course or the course is canceled. The balance of the tuition is due one week prior to the first class session for each course after which no refund will be made.Apply Now
Applications are accepted on a first-come/first-registered basis. Students will receive confirmation of enrollment via email. We reserve the right to cancel any course that does not meet minimum enrollment requirements.