نظرة عامة على البرنامج

---

Online Graduate Certificate in Pharmaceutical and Medical Device Compliance

The Drexel University Kline School of Law's online Graduate Certificate in Pharmaceutical and Medical Device Regulatory Compliance is designed for those who need a comprehensive knowledge of the legal, regulatory, and ethical frameworks surrounding the field of pharmaceutical and medical device manufacturing, marketing, and sales.

Program Overview

The program combines a core curriculum of legal compliance, risk assessment, and data privacy with an in-depth study of how industry regulators approach regulation around the research, development, sales, and marketing of pharmaceuticals, biologics, and medical devices.

What is a Graduate Certificate in Regulatory Affairs in Medical Devices and Pharmaceuticals?

The goal of a graduate certificate in regulatory affairs is to help you gain a working knowledge of the legal and compliance frameworks of a specific industry. This online program is designed to help you navigate the complex regulatory world of the pharmaceutical and medical device industry.

Program Features

• Completely online format lets you learn when it's convenient for you
• Take classes on a full-time or part-time basis
• Learn from the nationally recognized faculty at the Thomas R. Kline School of Law
• Classes are highly interactive and allow you to engage (and network) with your professors and classmates
• Utilize the Kline Graduate Programs Virtual Career Office which is dedicated to helping you reach your career goals via access to job postings, a virtual career classroom, and one-on-one coaching with faculty and alumni

Career Opportunities

The Kline School of Law certificate program prepares you for roles throughout the pharmaceutical and medical device industry. Common job titles within this field include:

• Clinical Research Associate
• Medical Device Auditor
• Medical Device Sales Representative
• Pharmaceutical Compliance Officer
• Pharmaceutical Sales Representative
• Pharmaceutical Regulatory Affairs Officer
• Regulatory Compliance Officer

Salary Expectations

Salary expectations for roles within the pharmaceutical and medical device industry vary based on exact titles, locations, etc. However, here are some common salaries and job titles to give you an idea of what to expect:

• Clinical Research Coordinator: $123,860
• Compliance Officer: $68,860
• Medical Device Sales Representative: $79,680
• Pharmaceutical Sales Representative: $79,680
• Regulatory Affairs Manager: $107,480
• Regulatory Affairs Specialist: $68,860

Related Programs

• Master of Legal Studies – Pharmaceutical and Medical Device Regulatory Compliance Concentration
• LLM in Health Care and Pharmaceutical Compliance
• Graduate Certificate in Health Care Compliance

Curriculum

This program is organized into four 10-week quarters per year. One semester credit is equivalent to 1.5 quarter credits.

Required Courses

Course	Description	Credits
LSTU 551	Compliance Skills: Auditing, Investigation & Reporting	4.0
LSTU 554	Risk Assessment and Management	4.0

Choose three electives from the following:

• LSTU 555: Compliance Communications
• LSTU 570: Health Care Fraud: Regulation, Investigation, and Enforcement
• LSTU 571: Legal Issues for Artificial Intelligence in Healthcare
• LSTU 602: Patients and Privacy: HIPAA and Related Regulations
• LSTU 603: Legal Regulation of Pharmaceutical and Medical Device Research and Development
• LSTU 604: Legal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices
• LSTU 605: Food and Drug Law
• LSTU 660: Information Privacy Law
• LSTU 661: The Law and Strategies Surrounding Cybersecurity
• LSTU 662: European Union Data Privacy and Protection

Total Credits

20.0

Admissions Criteria

• A bachelor's degree from a regionally accredited institution

Required Documents

• 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

Tuition

The tuition rate for the academic year is $975 per credit.

• This program is not eligible for Financial Aid.
• Special tuition rates available for Drexel University Alumni, Military members, and members of our Partner Organizations.

Academic Calendar

Academic Year 2025-2026

• Fall 2025: September 22, 2025 - December 6, 2025
• Winter 2026: January 5, 2026 - March 14, 2026
• Spring 2026: March 30, 2026 - June 6, 2026
• Summer 2026: June 22, 2026 - August 29, 2026