Regulatory affairs is not a career path you master overnight. Whether you work in medical devices, pharmaceuticals, biologics, combination products, or in vitro diagnostics (IVDs), the learning continues throughout your career.
If your regulatory affairs career is just beginning, these online courses provide the foundational knowledge that will propel you forward. There are also several options that fit if you are looking to learn something new or brush up on your skills, no matter your level of experience.
Table of contents
Online regulatory affairs courses from RAPS: the benefits
Online regulatory affairs courses: the basics
Courses vs. Certificates vs. Certifications
Online regulatory affairs courses in medical devices and IVDs
Online regulatory affairs courses in pharmaceuticals and biologics
Regulatory affairs courses for anyone
Online regulatory affairs courses from RAPS: the benefits
Regulatory affairs professionals play a pivotal role in getting healthcare products to the people who need them and ensuring products are safe and effective.
RAPS has supported and elevated the regulatory affairs profession for more than 50 years with education written by regulatory professionals, for regulatory professionals. Here are a few reasons to learn with us:
- Every RAPS online course is crafted with experts. RAPS works with regulatory affairs professionals who are authorities in the field to create and update each course in our catalog.
- Every course is self-paced, allowing you to fit learning into your calendar alongside other personal and professional commitments.
- Take a course on its own...or build to something bigger. RAPS certificates and bundles let you fast-track your educational journey.
- Showcase your knowledge. Each course comes with a downloadable certificate to add to your LinkedIn profile.
Online regulatory affairs courses: the basics
Are you at the start of your regulatory affairs career? Just looking to learn more about the profession? Start with the essentials.
Ethics
Making the right decision isn’t always easy. Consumers today expect and demand integrity, honesty, and transparency. In this course, you will learn the importance of doing the right thing when product quality is at risk. With history that includes actual cases that impacted consumer safety and trust, you'll be prepared to handle situations that don’t always involve easy answers or clear decisions. Learn more.
Regulatory is a dynamic discipline that brings you into contact with almost all of a company’s various departments and disciplines. This course discusses the evolution of the regulatory profession, its roles and responsibilities, and how those fit within various healthcare organizations. It also briefly outlines the critical events and their impact for each product lifecycle stage for drugs, biologics and medical devices. Learn more.
The Role of the Regulatory Professional
Regulatory is a dynamic discipline that brings you into contact with almost all of a company’s various departments and disciplines. This course discusses the evolution of the regulatory profession, its roles and responsibilities, and how those fit within various healthcare organizations. It also briefly outlines the critical events and their impact for each product lifecycle stage for drugs, biologics and medical devices. Learn more.
Pharmaceuticals: Definition and Lifecycle
Pharmaceuticals and biologics undergo a long complex development process before being made available for the treatment or prevention of diseases. This course introduces you to that process, covering the many functional areas involved in pharmaceutical development, including the drug development process and the regulatory requirements that govern the pharmaceutical industry. Learn more.
Global Regulatory Strategy for Pharmaceuticals
This course describes the challenges and goals you will face when defining a global regulatory strategy for a pharmaceutical product. It provides an examination of the regulatory considerations in the major regions of the world where marketing applications are pursued and compares the application requirements in these regions. It also includes a description of the regulatory “tools” at the disposal of the regulatory professional and discusses reimbursement considerations and how they may affect strategy development from both a global and regulatory perspective. Learn more.
Medical Devices: Definition and Lifecycle
Medical devices undergo a long and complex development process before they can be made available for therapeutic or diagnostic use. This course is a primer on the history of medical devices and general aspects of product and regulatory lifecycles. Learn more.
Global Regulatory Strategy for Medical Devices
This course describes the necessary steps to create a global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful global strategies for medical devices, with definitions and classifications worldwide, elements of regulatory strategy, sources of competitive and regulatory intelligence, selection of development and product approval pathways and suggestions for professional development. Learn more.
Courses vs. Certificates vs. Certifications
RAPS certificates in medical devices, pharmaceuticals, or both allow you to learn foundational regulatory affairs knowledge. Credentials like the Regulatory Affairs Certification (RAC), Regulatory Compliance Certification (RCC), and Foundation in Regulatory Affairs (FRA) validate your knowledge through an exam. Find the one that’s right for you.
Online regulatory affairs courses in medical devices and IVDs
Medical Devices: US Regulations
This course dives into the history of medical device regulation, explains the steps required to submit an application to FDA for approval or clearance, and provides details on staying compliant with postmarket requirements to ensure a device stays on the market. Learn more.
Regulation of IVDs in the US and Major Markets Outside the US
This course explains the historical background of today’s regulations governing in vitro diagnostic (IVD) products. It introduces key regulations and guidelines necessary for effective product development, testing, and premarket submission in the US, EU, and other major markets. Learn more.
Medical Devices: EU Regulations
This course covers the history and current state of medical device regulation in Europe. Designed to give you a strong foundation in the key elements of the EU regulations governing medical devices, it examines the regulatory requirements that need to be met before and after placing a medical device on the market in the EU, with a focus on EU MDR and IVDR. Learn more.
Online regulatory affairs courses in pharmaceuticals and biologics
Pharmaceuticals: US Regulations
Get an in-depth understanding of US pharmaceutical regulations, with historical justifications that provide the logic for today’s rules and guidances and an exploration of the current state of US pharmaceuticals. As pharmaceutical companies continue to apply innovative scientific methods, the ability to understand and accurately interpret applicable regulations and guidance is critical to both successfully managing a product’s lifecycle and to protecting public health. Learn more.
Pharmaceuticals: EU Regulations
This course provides an overview of the regulations and legislative framework required for a product to be granted a marketing authorization in the EU, as well as the European Medicines Agency (EMA) entities responsible for medicinal product reviews. In this course, you will learn about the different application and registration procedures, with an explanation of the regulatory requirements throughout the product lifecycle, including marketing and postmarketing requirements, and prescription to over-the-counter switches. Learn more.
Chemistry, Manufacturing and Controls (CMC)
Information on chemistry, manufacturing, and controls (CMC) is a crucial part of any drug submission. This course explains the CMC information necessary to support original investigational applications, with details on the types of CMC changes that require investigational application amendments and the information needed to support marketing applications and postapproval submissions, including the use of Drug Master Files (DMFs) and CMC-specific guidances. Learn more.
Regulatory affairs courses for anyone
While many courses dive into a specific product area like pharmaceuticals or medical devices, regulatory affairs professionals also need skills that transcend sector. These courses instead focus on the other functional skills and knowledge areas you need to succeed in regulatory affairs.
Regulatory writing: plain language
Through practical exercises and real-world examples, this course helps you apply important concepts including fit-for-purpose writing, organization, and persuasiveness to your regulatory writing. By the end of this course, you will be equipped with the skills to make your writing clear, effective, and impactful, positioning you as knowledgeable, credible, and articulate, and positioning your regulatory submissions for success. Learn more.
Project management for regulatory professionals
Commonly used in engineering and IT applications, project management principles, tools and techniques can help with planning, control, monitoring and review of project tasks in the regulatory profession. This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports. Learn more.
Effective regulatory communication
The ability to convince and persuade others is a necessary skill for anyone looking to advance in regulatory affairs. This course will show you how to create an effective communication strategy for internal stakeholders, external stakeholders, marketing applications, and more. Learn more.
More than 50 online learning opportunities that let you choose your regulatory education
RAPS online courses are designed to help you advance in your career with trusted information from regulatory affairs experts. See how they can help you and your team.