Jump-start your regulatory career with a RAPS Regulatory Affairs Certificate
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.
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:
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
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
Medical Devices & Pharmaceuticals (Dual)
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 Pharmaceuticals
- Pharmaceuticals: Definition & Lifecycle
- Role of the Regulatory Professional
Single Certificate
Member: $2,545 USD
Nonmember: $3,190 USD
Pharmaceuticals
Core Courses
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
See why learners love our Online University Certificate Program
“I liked that I was able to select courses that were closely aligned with my job while also exploring other topics!”
Clare R.
“This certificate helped me build a foundation of knowledge for pursuing my career change. With this solid foundation, I’m more confident to pursue my career path.”
Raawa H.
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
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, 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
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!
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.
Regulatory Essentials
Pharmaceuticals
Medical Devices
Quality
Clinical
These courses are designed to challenge your knowledge and provide the information you need to do your job better.
Regulatory Affairs Certificate Programs
“I loved the Certificate Program because I was able to make it work for me, rather than the other way around. The self guided, self-paced courses allowed me to take the courses in my own time and be in control of my own schedule. I also really enjoyed that I was able to pick 5 out of the 9 courses and tailor my experience to what I wanted to focus on.”
Kyla R.
Want a study partner? Consider getting a group together. Contact us today about corporate or group rates.
Need a boost in your career?
Enroll in a RAPS Online University Certificate program.