The Kline School of Law sits, geographically, at the epicenter of hundreds of small and large pharmaceutical, medical device and biotech companies. This concentration (and certificate when approved) is designed for professionals working in the industry who want to enhance their knowledge of the legal, regulatory and ethical frameworks surrounding pharmaceutical and medical device research, development, sales, marketing and related information privacy and compliance issues.

Core Courses (25 Credits)

• LSTU 550 Introduction to the Legal System (4 credits)
• LSTU 551 Compliance Skills: Auditing, Investigation & Reporting (4 credits)
• LSTU 552 Ethics and Professional Standards (4 credits)
• LSTU 553 Legal Research and Analysis (4 credits)
• LSTU 554 Risk Assessment and Management (4 credits)
• LSTU 560 MLS Masters Capstone (3 credits)
• LSTU 561 MLS Masters Capstone (2 credits)

Pharmaceutical and Medical Device Regulatory Compliance Concentration (20 Credits)

Select five from the list below:

• LSTU 555 Compliance Communications (4 credits)
• LSTU 602 Patients and Privacy: HIPAA and Related Regulations (4 credits)
• LSTU 603 Legal Regulation of Pharmaceutical and Medical Device Research and Development (4 credits)
• LSTU 604 Legal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices (4 credits)
• LSTU 605 Food and Drug Law (4 credits)
• LSTU 660 Information Privacy law (4 credits)
• LSTU 661 The Law and Strategies Surrounding Cybersecurity (4 credits)
• LSTU 662 European Union Data Privacy and Protection (4 credits)