Curriculum and Faculty
The online Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance consists of three credits, taught over a period of eight weeks. The material focuses on both substantive legal and policy issues and basic legal research and writing skills. Topics to be covered include the following:
Module 1: The Drug and Device Approval Process
Module 2: FDA Oversight of Advertising and Promotion
Module 3: Anti-Kickback Law and False Claims Act
Module 4: International Anti-Bribery Laws
Module 5: Corporate Integrity Agreements and the Responsible Corporate Officer Doctrine
How Will the Courses Be Taught?
Legal education is a highly interactive endeavor. In a traditional law school classroom, this interactivity is achieved through back-and-forth dialogue between the professor and students.
The online Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance relies on a variety of innovative learning modalities to create a similar level of interactivity in the online environment. Examples include moderated discussion boards, individual and group-based problem-solving exercises, and one-on-one professor-student interactions. The low student-faculty ratio (no more than eight students per professor) promotes strong relationships between professors and students. Professors participate actively in discussion forums and Q&A boards and give students individualized feedback on all written work.
Faculty
The online Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance will be team-taught by Carl Coleman, a tenured professor at Seton Hall Law School with nearly two decades’ experience in health law and policy, and Kate Greenwood, a Research Fellow and Lecturer in Law at Seton Hall's Center for Health & Pharmaceutical Law & Policy.