Advanced Topics in Food and Drug Law (Pharmaceutics 5605)
6:00 pm – 9:00 pm Wednesdays: Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11. Meets 12 times plus final exam. Make-ups, if needed, Apr 18 or 25.
Proctored exam: tba (Software Secure)
Description: Depth and Breadth
This course is partly an extension of Food and Drug Law (Pharmaceutics 5592), delving into certain already introduced topics in greater depth because of their significance (federal preemption and the different court outcomes depending on product type; challenges to the Park Doctrine in criminal enforcement) and mostly an introduction to additional topics of significance to FDA-regulated industries (Intellectual Property—Patents, Trade Secrets, Trademarks—how regulated and how protected; Product Liability; Post-Marketing Approval Issues—Commercial Free Speech, False Claims Act, General Promotional Issues; Research Liabilities—Foreign Corrupt Practices Act, Stark Act, Common Rule issues, Clinical Contracting, Expanded Access, Conflicts of Interest, Sunshine Act). Additionally, “hot” topics in the news (unpredictable by their nature) are added to our syllabus.
There is a substantive proctored midterm and in lieu of a final exam, students research and prepare a paper on an approved topic of their own choosing (professor will supply a list of suggested topics at the start of the semester) and in-class PowerPoint presentation and outline/bibliography for their fellow students. In the past this has been a stimulating addition to the syllabus with many additional topics introduced to the class (e.g. stem cell research, counterfeit drugs, GMOs, Controlled Substances, Medical Device Software and more).
The goal of the course is twofold: depth and breadth. Some of the topics introduced have more in-depth coverage available in the RAQA program and it is hoped FDA II provides insights to enable the student to select electives of interest/relevance. It is also hoped that students will develop their analytical and strategic thinking as a result of filling in the “big picture” of issues affecting FDA-regulated industries
Note: there is no required textbook purchase for this course due to the diversity of topics and significant use of primary resources off the internet (statutes, regulations, guidances, standards) but peer-reviewed articles will be included as required reading as background for lectures and basis for discussion. To further participation, a series of questions will be provided in advance of class for preparation and live discussion.
Prerequisite: Food and Drug Law (5592) or permission of the instructor (forward resume with registration form).
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam.
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We have changed our name from Quality Assurance/Regulatory Affairs (QA/RA) to the Regulatory Affairs and Quality Assurance Graduate Program (RA and QA) due to Search Engine issues.