Certificate in Medical Devices and Pharmaceuticals Regulation

The Certificate in Medical Devices and Pharmaceutical Regulation is achieved by completing six core and eight elective courses.

Build a solid body of regulatory knowledge and advance your career with a RAPS Online University certificate. The dual certificate in medical devices and pharmaceuticals features a comprehensive curriculum with eight electives that you select from a wide range of topics including clinical, quality, pharmaceuticals and biologics, medical devices, and regulatory essentials.

This program is created by regulatory experts and is ideal for those who are new to the profession, medical devices and/or pharmaceuticals industry, transitioning from a related discipline, or simply looking to refresh your knowledge. Customize this comprehensive and flexible program to meet your learning needs.

Elevate your certificate program by completing two Foundation in Regulatory Affairs (FRA) exams, which are included. Once you pass the exam, you will earn a credential that allows you to display a digital badge and add it to your resume.

Interested in earning a dual certificate but not sure if you are ready to take on that much at once? Start by enrolling in an individual certificate program and upgrade to the dual certificate when you're ready for more.

Program Details

The Certificate in Medical Devices and Pharmaceuticals Regulation is achieved by completing six (6) core and eight (8) elective courses.

You will have 12 months to complete all 14 courses. After successfully completing all 14 courses, you will receive a certificate recognizing your achievement.

Core Courses

The following six courses are required as part of the program:

Ethics
Global Regulatory Strategy for Pharmaceuticals
Global Regulatory Strategy for Medical Devices
Pharmaceuticals: Definition & Lifecycle
Medical Devices: Definition & Lifecycle
Role of the Regulatory Professional

Elective Courses

You also choose five courses from our designated portfolio of programs. These courses are labeled with a M, P or M/P. This means these courses are valid electives for the dual certificate.

Download the Course Catalog

Foundation in Regulatory Affairs (FRA) Exams: Introduction to Pharmaceuticals and Introduction to Medical Devices

Here are a few key things to know about the included FRA exams. If you want to know more about these credentials, please visit the FRA page.

You have 12 months to take either or both of the FRA exams.
The FRA exams are separate from the end of course assessments.
Materials may NOT be used during the exam.
You will have 5 attempts to pass each FRA exam.
Exam results will be provided at the end of each exam attempt.

Registration

Note: If you have already registered for a RAPS Online University course that is included as part of this certificate program, you may be able to apply it toward the program requirements and registration fee. Contact us to see if your course(s) qualifies.

More questions about the certificate program? Check out the certificate FAQs

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