Post-Baccalaureate Certificate in Pharmaceutical and Medical Device Regulatory Compliance
Certificate Level: Graduate
Admission Requirements: Bachelor's degree
Certificate Type: Post-Baccalaureate
Number of Credits to Completion: 15.0
Instructional Delivery: Online
Calendar Type: Semester
Expected Time to Completion: 1.5 year
Financial Aid Eligibility: Not aid eligible
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.
*Note: This program is now being offered on the quarter schedule only. Please refer to the Pharmaceutical and Medical Device Regulatory Compliance (Certificate)- Quarter Calendar program.
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
This program is designed to be completed on a part-time basis and requires 15.0 semester credits. Students usually finish this program in 1.5 years. If a student needs to decelerate, they should not exceed 2.5 years. Students may apply for transfer in to the Master of Legal Studies program prior to completing their certificate, and apply all earned credits toward the Master of Legal Studies.
Program Requirements
| LSTU 501S | Compliance Skills: Auditing, Investigation & Reporting | 3.0 |
| LSTU 507S | Risk Assessment and Management | 3.0 |
| Choose three from the list below: | 9.0 | |
| European Union Data Privacy and Protection | ||
| 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 | ||
| Patients and Privacy: HIPAA and Related Regulations | ||
| Information Privacy Law | ||
| The Law and Strategies Surrounding Cybersecurity | ||
| Compliance Communications | ||
| Total Credits | 15.0 | |
Sample Plan of Study
| First Year | |||||
|---|---|---|---|---|---|
| Fall | Credits | Spring | Credits | Summer | Credits |
| LAW 785S | 3.0 | LAW 787S | 3.0 | LAW 770S | 3.0 |
| LSTU 501S | 3.0 | LSTU 507S | 3.0 | ||
| 6 | 6 | 3 | |||
| Total Credits 15 | |||||
