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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.


Regulatory 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.

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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.

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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.

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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.

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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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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.

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Essentials of Safety Medical Writing On-Demand Training

Everything you need to know to effectively write safety reports.

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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.

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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.

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Machine Learning in Pharmacovigilance On-Demand Training

Explore how machine learning is used within the regulatory and pharmacovigilance landscape with this on-demand course.

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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.

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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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