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  • Online Graduate Certificate in Pharmaceutical and Medical Device Compliance

    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. The program combines a core curriculum of legal compliance, risk assessment, and data privacy with an in-depth study of how industry regulators (like the Food and Drug Administration) 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. The core courses of the five-course, 15-credit certificate cover compliance foundational skills such as auditing, investigation, and risk management. You can then choose three electives on topics such as Food and Drug Law, Information Privacy Law, or Legal Regulations of Pharmaceutical and Medical Device Sales and Marketing Practices.

    Online Graduate Certificate in Pharmaceutical and Medical Device Compliance 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
    • Beginning in the Fall of 2022, the Kline School of Law’s fully online degree and certificate programs will be offered on the 10-week Quarter system and will no longer be offered on the 14-week Semester system. Students who start before Fall 2022 will transfer their credits to the quarter program. For questions, please contact lawadmissions@drexel.edu.

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    What Jobs Can I Get With a Pharmaceutical Regulatory Affairs Certificate?

    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

    What Are the Salary Expectations for Jobs in the Pharmaceutical Industry?

    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:

    Position

    2018 Median Salary*

    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

    *Data from O*Net

    Related Programs


    State restrictions may apply to some programs.

    Curriculum

    This program is organized into four 10-week quarters per year (as opposed to the traditional two semester system) which means you can take more courses in a shorter time period. One semester credit is equivalent to 1.5 quarter credits.

    Beginning in the Fall of 2022, the Kline School of Law’s fully online degree and certificate programs will no longer be offered on the 14-week Semester system. Students who start before Fall 2022 will transfer their credits to the quarter program. For questions, please contact lawadmissions@drexel.edu.

    Required Courses  
    LSTU 551 Compliance Skills: Auditing, Investigation, & Reporting 4.0
    LSTU 554 Risk Assessment and Management 4.0
    Select three of the following: 12.0
    LSTU 555 Compliance Communications  
    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

    View Course Descriptions

    Admissions Criteria

    • A bachelor's degree from a regionally accredited institution

    Required Documents

    With multiple ways to submit documents, Drexel makes it easy to complete your application. Learn more by visiting our Completing Your Application Guide.

    • 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 2022-2023 is $880 per credit.

    The Thomas R. Kline School of Law online graduate programs have recently switched to a quarter calendar schedule. The tuition rate reflected above is now per quarter credit.

    • This program is not eligible for Financial Aid.
    • Special tuition rates available for Drexel University AlumniMilitary members, and members of our Partner Organizations.
      • Spring 2020 new partners, alumni, or military students only: A special 20% tuition savings for students that enroll in two classes during their first term of enrollment and stay enrolled in two classes per term throughout the length of the program (otherwise standard tuition savings applies). Must maintain continuous enrollment in the program during the Fall and Spring semesters. Students will initially see a 10-15% tuition savings on their bill. An additional savings to bring the total to 20% will be credited after the close of the add/drop period at the beginning of the semester.
        • These rates apply only to new online students and students being readmitted.
        • These rates apply only to fully online courses. Hybrid or on-campus courses may have different rates.
        • Tuition rates are subject to increase with the start of each academic year in the fall term.
        • All students must contact applyDUonline@drexel.edu within the first two weeks of the term to request tuition savings for which they qualify.
        • Special rates cannot be combined. If you qualify for more than one special rate, you'll be given the one with the largest savings.
        • When receiving special tuition plans with Drexel University Online, you may not combine them with other tuition benefits that may be available from Drexel University.

     

    Academic Calendar

    2022-2023 Academic Year

    Term

    Classes Begin

    Classes End

    Exams Begin

    Exams End

    Fall 2022

    September 19, 2022

    December 3, 2022

    December 5, 2022

    December 10, 2022

    Winter 2023

    January 9, 2023

    March 18, 2023

    March 20, 2023

    March 25, 2023

    Spring 2023

    April 3, 2023

    June 10, 2023

    June 12, 2023

    June 17, 2023

    Summer 2023

    June 26, 2023

    September 2, 2023

    September 4, 2023

    September 9, 2023

     

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