Regulatory Basics Bundle - US & Canada
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
Enrollment Period: 12 months
Courses included in this bundle:
Role of the Regulatory ProfessionalExamine 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 LifecycleLearn 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 LifecycleGain 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 US and CanadaLearn 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
