Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.
The Regulatory Basics bundle is ideal for new professionals, students and career transitioners who need to learn the core concepts and key principles for operating in the health product sector's regulated environment.
The courses provide fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets. Paired together, these courses serve as an excellent foundation for regulatory affairs knowledge.
Select which bundle option is right for you:
Courses included in this bundle:
Role of the Regulatory Professional Examine the evolution of the profession and a professional’s roles and responsibilities. It also outlines critical events and their impact throughout the product lifecycle for drugs, biologics and medical devices. 1 Hour | 1 RAC credit
Pharmaceuticals: Definition and Lifecycle Learn basic terminology as well as the lifecycle development stages including early-stage research, nonclinical and clinical trials, manufacturing, marketing and postmarketing. 1–2 Hours | 1 RAC credit
Medical Devices: Definition and Lifecycle Gain an introduction to general aspects of product and regulatory lifecycles. It also provides a brief history of medical device regulation and information on basic regulatory principles and concepts. 1–2 Hours | 1 RAC credit
Introduction to Regulatory Affairs in the EU Get a basic understanding of the regulatory requirements to obtaining marketing approval for healthcare products––Centralised Procedure, Decentralised Procedure, Mutual Recognition Procedure National Procedure as well as approvals performed by Notified Bodies (NBs). 1–2 Hours | 1 RAC credit
Introduction to Regulatory Affairs in the US and Canada Learn about the agencies primarily responsible for regulating healthcare products in these countries—the US Food and Drug Administration (FDA) and Health Canada and review applicable legislation that drives their regulatory processes. 2–4 Hours | 2 RAC credits