Post-Baccalaureate Certificate in Pharmaceutical and Medical Device Regulatory Compliance
Certificate Level: Graduate
Certificate Type: Post-Baccalaureate
Number of Credits to Completion: 15.0
Classification of Instructional Program (CIP) Code: 44.0503
Standard Occupational Classification (SOC) Code: 11-9111
About the Program
The certificate in Pharmaceutical and Medical Device Regulatory Compliance is a post-baccalaureate, non-degree program designed for individuals to develop and improve career-related skills in the highly regulated field of pharmaceutical and medical device manufacturing, marketing, and sales. The program combines a core of legal compliance, risk assessment, and data privacy classes with in-depth study of the industry regulators, including the Food and Drug Administration, and their approach to regulation around research, development, sales, and marketing of pharmaceuticals, biologics and medical devices. Ideal candidates include individuals working in and around pharmaceutical, biologic, or medical device research, manufacturing, and sales, among others.
Admission Requirements
- A completed application
- Official transcripts from all universities or colleges and other post-secondary educational institutions (including trade schools attended)
- Resume
- Additional requirements for international students
Program Requirements
| Program Requirements | ||
| LSTU 5551 | Compliance Skills: Auditing, Investigation and Reporting | 3.0 |
| LSTU 5554 | Risk Assessment and Management | 3.0 |
| Choose three from the list below: | 9.0 | |
| Compliance Communications | ||
| Health Care Fraud: Regulation, Investigation, and Enforcement | ||
| Legal Issues for Artificial Intelligence in Healthcare | ||
| Patients and Privacy: HIPAA and Related Regulations | ||
| Legal Regulation of Pharmaceutical and Medical Device Research and Development | ||
| Legal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices | ||
| Food and Drug Law | ||
| Information Privacy Law | ||
| The Law and Strategies Surrounding Cybersecurity | ||
| European Union Data Privacy and Protection | ||
| Total Credits | 15.0 | |
Additional Information
For more information about this program, please contact the Thomas R. Kline School of Law