Course Catalog

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RAPS course bundles consist of relational topics that intersect in practice. Bundles offer a quick and cost-effective option to build expertise in a defined area.

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Product Bundle Product Bundle
Clinical Trial Foundations Bundle
Member: $575.00 Nonmember: $790.00
Improve your knowledge surrounding the proper conduct of clinical research with human subjects.
Product Bundle Product Bundle
GxP Bundle
Member: $865.00 Nonmember: $1,292.00
This three-course series examines essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
Product Bundle Product Bundle
Regulatory Basics Bundle - Complete
Member: $500.00 Nonmember: $700.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Product Bundle Product Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Package #1]
Member: $1,050.00 Nonmember: $1,440.00
Learn more about the components of various application types and techniques for improving document quality.

The Regulatory Affairs Certificate Program is an online series of courses you personalize to meet your professional development needs. These customizable study pathways include four core courses that are required and five electives across the topical areas of regulatory essentials, medical devices, pharmaceuticals, quality and clinical.

Browse all Certificate Programs »
Online Course Online Course
Dual Certificate Dual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,590.00 Nonmember: $4,490.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Medical Devices
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Medical Devices is achieved by completing four core and five elective courses.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Medical Devices
Member: $1230 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Pharmaceuticals, you can complete the two remaining core courses of the Dual Certificate and three additional electives.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1230.00 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.

RAPS webcasts cover the trends and tools to help you maximize your regulatory efforts. Our on-demand library provides you with access to stream past webcasts and virtual events for 12 months. These webcasts offer you the ability download the presentation slides and handouts from the RAPS Learning Portal. Upon completion of the event, you can earn RAC credit for those looking to recertify.

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On-demand On-demand
Sponsored Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
1.0 RAC Credits
Member: $0 NonMember: $20
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.
On-demand On-demand
Meet the Authors: Orphan Drug Development for Rare Diseases
1.0 RAC Credits
Member: $0 NonMember: $20
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.
On-demand On-demand
Best Practices on MDR Transition Under Current Conditions (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $20
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
On-demand On-demand
FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
On-demand On-demand
Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $20
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.
On-demand On-demand
Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices
1.0 RAC Credits
Member: $0 NonMember: $20
Four authors from the latest RAPS book, Global Pediatric Development of Drugs, Biologics, and Medical Devices, will be on hand to answer all your burning questions on global pediatric development in regulatory affairs.
On-demand On-demand
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.

RAPS Online courses provide you with education options to hone your skills in your area of expertise. We offer over forty courses across the topical areas of regulatory essentials, medical devices, pharmaceuticals, quality and clinical that can be taken individually.

Interested in taking more than one course? Check out RAPS Online University Bundles and Certificate Programs.

Denotes Medical Device Certificate Elective  Denotes Medical Device Certificate Elective

Denotes Medical Device Certificate Elective  Denotes Pharmaceutical Elective

Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development.
Online Course Online Course
An Essential Guide to Horizontal Role Change Thinking
Member: $95 Nonmember: $105
Sometimes the next step in one's career is not in the next-level role, but in something else. This tutorial will help you demonstrate that you can undertake a different role.
Online Course Online Course
An Essential Guide to Vertical Career Thinking
Member: $95 Nonmember: $105
This tutorial seeks to reframe one's thinking about expected performance. Providing insights which are typically absent or unclear from position descriptions.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Chemistry, Manufacturing and Controls (CMC) [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides an overview of the CMC section of dossiers.
Online Course Online Course
Dual Certificate Dual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,590.00 Nonmember: $4,490.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Globalization of Clinical Research Trials and Investigations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Effective Regulatory Communication [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Reference Package: Basic
Member: $360 Nonmember: $475
Purchase the Fundamentals of Medical Device Regulations, Third Edition and RAC (Device) Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Reference Package: Basic
Member: $360 Nonmember: $475
Purchase the Fundamentals of Medical Device Regulations, Third Edition and RAC (Device) Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
RAC Prep RAC Prep
RAC (Drugs) Practice Test
Member: $85.00 Nonmember: $105.00
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Prep Toolbox with Print Edition of Fundamentals of Medical Devices Regulations
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Prep Toolbox with Print Edition of Pharmaceutical and Biologics Fundamentals Book
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep RAC Prep
RAC (Devices) Practice Test
Member: $85.00 Nonmember: $105.00
RAC Prep RAC Prep
RAC (Devices) Prep Toolbox
Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep RAC Prep
RAC (Drugs) Prep Toolbox
Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.