Jump-start your regulatory career with a RAPS Online University Certificate from

RAPS E-Learning

Offered in two tracks—pharmaceuticals and medical devices—with the option to take both together. RAPS Online University certificates offer well-recognized, flexible, and cost-effective regulatory education.

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The Regulatory Affairs Certificate Program is an online series of courses you personalize to meet your professional development needs. Designed for regulatory professionals in their first five years in the regulatory field, this certificate program is comprehensive and flexible to help you achieve your goals. You can specialize in medical devices, pharmaceuticals, or study both specialties together with the dual certificate program.

Each Regulatory Affairs Certificate Program is built on 
a core curriculum of essential courses, including ethics, the role of the regulatory professional, global regulatory strategy and lifecycles & definitions.

You’ll customize the majority of your certificate program by hand-selecting individual electives from over forty courses across the topical areas of:

Regulatory Affairs Certificate Program Courses

Medical devices

Core Courses

The following 4 courses are required as part of the program requirements in addition to 5 elective courses :

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

Single Certificate
Member: $2,545 USD
Nonmember: $3,190 USD

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Core Courses

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Medical Devices and Pharmaceuticals (Dual)

The following 6 courses are required as part of the program requirements in addition to 8 elective courses :

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

Dual Certificate
Member: $3,880 USD
Nonmember: $4,850 USD

RECOMMENDED

Pharmaceuticals

The following 4 courses are required as part of the program requirements in addition to 5 elective courses :

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

Single Certificate
Member: $2,545 USD
Nonmember: $3,190 USD

Core Courses

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RAPS Online University
Complete Course Offerings

Effective Regulatory Communication

M

P

Essentials

Medical Devices

Pharmaceuticals

Quality

Clinical

Ethics

M

P

FDA Law and Regulation

M

P

P

M

Intermediate Medical Writing: Investigational Applications

Intermediate Medical Writing: Investigational Applications

Intermediate Medical Writing: Medical Devices

M

Intermediate Medical Writing: Medical Devices

P

Introduction to Regulatory Affairs in the EU

M

P

Introduction to Regulatory Affairs US and Canada

M

P

Introductory Medical Writing

M

P

Project Management for Regulatory Professionals

M

P

Regulatory Due Diligence for Product Development

M

P

Role of the Regulatory Professional

M

P

Supplier Management

M

P

Supply Chain Controls

M

P

M    Denotes Medical Device Certificate Elective
P     Denotes Pharmaceutical Elective

RAPS Online University
Complete Course Offerings

Denotes Medical Device
Certificate Elective
Denotes Pharmaceutical
Elective

M

P

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See why learners love our Online University Certificate Program

I liked that there were required courses and elective courses to tailor the program toward my interests.

Kevin H.

The program helped clarify many aspects of the regulatory process and gain a better understanding of how my role in the review of print advertising makes an impact on the company.

Lia P.

I liked how in depth each lesson was, I felt as though I learned a great deal of new information from each course.

Carly C.

Frequently Asked Questions

Need a boost in your career?

Enroll in a RAPS Online University Certificate program

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Need a boost in your career?

Please note, the Certificate program does not confer RAC status. The only way to gain RAC status is to take and pass one of the RAC exams.

Privacy Policy | Terms & Conditions | ©Regulatory Affairs Professionals Society

Jump-start your regulatory career with a RAPS Online University Certificate from

Offered in two tracks— pharmaceuticals and medical devices with the option to take both together—RAPS Online University certificates offer well-recognized, flexible, and cost-effective regulatory education.

The Regulatory Affairs Certificate Program is an online series of courses you personalize to meet your professional development needs. With lots of options, it can be intimidating to choose the right path. We’ve laid out these pathways to help you with a starting point.  These general studies pathways include four core courses that are required and five electives.  No one knows better than you what your regulatory learning needs are, so who better to build a certificate program that meets them. First, explore the certificate program that suits you best.

Each Regulatory Affairs Certificate Program is built on a core curriculum of essential courses, including ethics, the role of the regulatory professional, global regulatory strategy and lifecycles & definitions.

Regulatory Affairs Certificate Program Courses

See why our students love our
Online University Certificate program

Frequently Asked Questions

Please note, the Certificate program does not confer RAC status. The only way to gain RAC status is to take and pass one of the RAC exams.

Privacy Policy | Terms & Conditions | ©Regulatory Affairs Professionals Society

Yes. You can access our learning products as soon as your purchase is confirmed. The courses will remain active under your account until 11:59 pm on the course closing date.
No. There is no specific order to taking courses and no prerequisites are required. The courses you take will depend on your experience in regulatory affairs, as well as your personal goals. In fact, most of our courses are designed to cover a certain topic and can be treated as its own entity. It’s believed that a good foundation of the regulatory framework will be helpful and certain courses are a good start and help you lay a good foundation for future professional development. Please click here to view a list of courses that are considered “essentials” for regulatory professionals. Besides all “essentials”, you can also find recommended course packages based on a different focus of regulatory affairs, such as medical devices, pharmaceuticals, quality or clinical. In addition to taking individual courses, you can also earn a certificate by taking our pre-packaged bundles for medical devices, pharmaceuticals, or a dual program for medical devices and pharmaceuticals.
We recommend that you select all your elective courses at the beginning of your study, but you can choose to complete the core courses first. You will have to select all of your electives before you begin. If you need to change your electives as you advance, we can accommodate your request to change electives.

Yes, but must meet the following criteria: Individuals with an active enrollment in a Regulatory Affairs Certificate may request to exchange an elective, provided the course has not been opened and has a “Not Started” status. Please note: After a course has been accessed it cannot be exchanged. *The close date for the Regulatory Affairs Certificate will apply to the replacement course.

RAPS Online University
Complete Course Offerings

Denotes Medical Device Certificate Elective
Denotes Pharmaceutical Elective

M

P

Effective Regulatory Communication

Ethics

FDA Law and Regulation

Intermediate Medical Writing: Investigational Applications

Intermediate Medical Writing: Medical Devices

Intermediate Medical Writing: Pharmaceuticals and Biologics

Introduction to Regulatory Affairs in the EU

Introduction to Regulatory Affairs US and Canada

Introductory Medical Writing

Project Management for Regulatory Professionals

Regulatory Due Diligence for Product Development

Role of the Regulatory Professional

Supplier Management

Supply Chain Controls

Global Regulatory Strategy for Medical Devices

Medical Devices: Advertising and Promotion in the US

Medical Devices: Canadian Regulations

Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview

Medical Devices: Compliance & Audits

Medical Devices: Corrections, Removals and Directed Recalls

Medical Devices: Definition & Lifecycle

Medical Devices: EU Regulations

Medical Devices: Postmarket Surveillance

Medical Devices: Risk Management

Medical Devices: US Regulations

Regulation of Combination Products

Regulation of IVDs for Key International Markets

Regulation of IVDs in the US

Chemistry, Manufacturing and Controls

Global Regulatory Strategy for Pharmaceuticals

Pharmaceuticals: Advertising and Promotional Labeling in the US

Pharmaceuticals: Canadian Regulations

Pharmaceuticals: Compliance & Audits

Pharmaceuticals: Definition & Lifecycle

Pharmaceuticals: EU Regulations

Pharmaceuticals: US Regulations

Pharmacovigilance

Regulation of Biosimilars

Regulation of Combination Products

Regulation of Dietary Supplements and NHPs

Regulation of Generic Drugs in the US

Regulation of US & EU Biologics

REMS and RMPs

Good Clinical Practice (GCP)

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Quality System Regulation (QSR)

Globalization of Clinical Research Trials and Investigations

Good Clinical Practice (GCP)

Understanding & Managing the US Clinical Trial Process

RAPS Online University
Complete Course Offerings

Effective Regulatory Communication
Ethics
FDA Law and Regulation
Intermediate Medical Writing:Investigational Applications
Intermediate Medical Writing: Medical Devices
Intermediate Medical Writing: Medical Devices
Introduction to Regulatory Affairs in the EU
Introduction to Regulatory Affairs US and Canada
Introductory Medical Writing
Project Management for Regulatory Professionals
Regulatory Due Diligence for Product Development
Role of the Regulatory Professional
Supplier Management
Supply Chain Controls
Global Regulatory Strategy for Medical Devices
Medical Devices: Advertising and Promotion in the US
Medical Devices: Canadian Regulations
Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview
Medical Devices: Compliance & Audits
Medical Devices: Corrections, Removals and Directed Recalls
Medical Devices: Definition & Lifecycle
Medical Devices: EU Regulations
Medical Devices: Postmarket Surveillance
Medical Devices: Risk Management
Medical Devices: US Regulations
Regulation of Combination Products
Regulation of IVDs for Key International Markets
Regulation of IVDs in the US
Chemistry, Manufacturing and Controls
Global Regulatory Strategy for Pharmaceuticals
Pharmaceuticals: Advertising and Promotional Labeling in the US
Pharmaceuticals: Canadian Regulations
Pharmaceuticals: Compliance & Audits
Pharmaceuticals: Definition & Lifecycle
Pharmaceuticals: EU Regulations
Pharmaceuticals: US Regulations
Pharmacovigilance
Regulation of Biosimilars
Regulation of Combination Products
Regulation of Dietary Supplements and NHPs
Regulation of Generic Drugs in the US
Regulation of US & EU Biologics
REMS and RMPs
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Quality System Regulation (QSR)
Globalization of Clinical Research Trials and Investigations
Good Clinical Practice (GCP)
Understanding & Managing the US Clinical Trial Process

Want a study partner?
Consider getting a group together. Contact us today about corporate or group rates.

VIEW CORPORATE OR GROUP RATES

Want a study partner?
Consider getting a group together. Contact us today about corporate or group rates.

These courses are designed to challenge your knowledge and provide the information you need to do your job better.

Did you know? All online courses are also available individually!

Not sure if you’re ready to take on the dual certificate? You can always start with an individual certificate and upgrade to the dual when you’re ready for more!

Did you know? All online courses are also available individually!

Not sure if you’re ready to take on the dual certificate? You can always start with an individual certificate and upgrade to the dual when you’re ready for more!

regulatory essentials

Pharmaceuticals

Medical devices

Quality

Clinical

Core Courses

ENROLL ONLINE

Medical Devices and Pharmaceuticals (Dual)

The following 6 courses are required as part of the program requirements in addition to 8 elective courses :

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

Dual Certificate
Member: $3,555 USD
Nonmember: $4,445 USD

RECOMMENDED

View Complete Course Catalog

View Complete Course Catalog