Regulatory Online Learning Courses
DIA's On-Demand courses enable learners to advance their personal development.
Increase your knowledge around regulatory topics through a series of video-based lessons, interactive exercises, and related resources. DIA’s online courses are available 24 hours a day, 7 days a week, and are mobile compatible making it convenient to learn anywhere, anytime.
Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training
Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.
Developing Companion Diagnostics: Regulatory and Clinical Considerations in the US and EU
Gain a better understanding of the global regulatory landscape for companion diagnostics, from key terminology and IVD classifications to the requirements guiding clinical studies and commercial products in the US and EU.
Essentials of Medical Devices and Combination Products
Discover the essential principles, regulatory insights, and compliance strategies for medical devices and combination products in this comprehensive on-demand training course.
Regulatory Affairs for Combination Products On-Demand Training
Explore FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.
Navigating Chemistry Manufacturing and Controls Through the Drug Development Process On-Demand Training
Review the CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) with this on-demand course.
Paediatric Investigation Plans On-Demand Training
Examine an introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation.
Real-World Evidence: The Evolving Landscape for Regulators, Data, and Integrated Use On-Demand Training
Learn how real-world evidence is being used today for evidence generation in major markets.
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Expand your knowledge about drug safety throughout the medical product development lifecycle from regulations and requirements to pre-market review and post-market monitoring in this six module program.
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Learn how organizations structure their efforts and utilize their resources to improve the odds of successful development in this six module program.
Patient Engagement eLearning Program
Explore the fundamentals of why and how to incorporate patient focus and build organization-wide capabilities with this six module eLearning Program.