On-Demand Courses
DIA's On-Demand courses enable learners to advance their personal development.
Through a series of video-based lessons, interactive exercises, and related resources included in DIA’s On-demand Courses, participants can learn at their own pace. The online courses are available 24 hours a day, 7 days a week, and are mobile compatible making it convenient to learn anywhere, anytime.
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Regulatory Affairs Courses
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.
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) using real-life scenarios.
Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development On-Demand Training
Learn more about the significant changes in Japanese pharmaceutical regulations and procedures which are impacting the development of new drugs in Japan as well as the rest of the world.
Global AdPromo: Considerations for Compliance and Success On-Demand Training
Review global advertising and promotion processes, regulations, and common pitfalls with particular focus on the EU and Canada in this on-demand course.
Real-World Evidence On-Demand Training
Learn how real-world evidence is being used today for evidence generation in major markets.
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Safety and Pharmacovigilance Courses
Safety Risk Communication for Medical Products On-Demand Training
Learn how to enhance the effectiveness of safety risk communication in light of evolving regulatory expectations.
Essentials of Safety Medical Writing On-Demand Training
Everything you need to know to effectively write safety reports.
The Pharmacovigilance Quality Management System On-Demand Training
Increase your knowledge of how to design, develop, and manage a quality system related to your pharmacovigilance system.
Safety Risk Management: A Focus on EU RMPs and US REMS On-Demand Training
Review the strategic and operational aspects of global risk management including key concepts, principles, and tools necessary to develop risk management programs.
Pharmacovigilance System Master File: How to Prepare and Maintain On-Demand Training
Review the essential concepts and guidances that govern the Pharmacovigilance System Master File (PSMF) in the European Union.
Benefit-Risk Assessment and Management Across the Lifecycle On-Demand Training
Develop your understanding of benefit-risk assessment methods and how to incorporate the patient perspective.
Machine Learning in Pharmacovigilance On-Demand Training
Explore how machine learning is used within the regulatory and pharmacovigilance landscape with this on-demand course.
Reference Safety Information On-Demand Training
Better understand basic aspects of the EU Regulation and Guidance that govern the content, placement, use, and management of the Reference Safety Information for assessing expectedness and causality to determine reportability of individual clinical trial cases.
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Clinical Research Courses
Adaptive Design in Clinical Trials: When and How to Apply On-Demand Training
Learn how adaptive design can reduce the cost and length of drug development and improve the probability of success.
Clinical Statistics for Nonstatisticians On-Demand Training
Review confidence intervals, hypothesis testing, trial designs, and methods for establishing noninferiority and equivalence.
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