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 bundle provides 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.
Courses included in this bundle:
Pharmaceuticals: Definition & Lifecycle
Learn basic terminology as well as the lifecycle development stages including early-stage research, nonclinical and clinical trials, manufacturing, marketing and postmarketing.
1 Hour | 1 RAC point
Medical Devices: Definition & 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 Hour | 1 RAC point
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.
2 Hours | 2 RAC points
Introduction to Global Healthcare Product Regulations
Discover key regulatory systems and mechanisms across a broad range of healthcare products, including medical devices, pharmaceuticals, biologics and combination products as well as major agencies in the United States (US), European Union (EU), Canada, Japan and Australia.
5 Hours | 5 RAC points