Regulatory Basics Complete
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.
Total Length: 5 Hours
Total RAC Points: 5
Learning Level: Basic
Enrollment Period: 12 months
Bundle includes:
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
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
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
