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Featured 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. Learners have access to courses for six months from the date of purchase.


Safety Risk Communication for Medical Products

Featured Topics:

  • Defining “Risk” in the Context of Medicinal Drug Products
  • What are the Goals of Risk Communication?
  • Risk Perception and Designing Effective Risk Communication
  • Successful Risk Communication
  • Risk Communication and Risk Management in the US and EU
  • Risk Communication Tools
  • Who’s Responsible for Communicating Drug Safety Information?
  • Evaluating Effectiveness of Risk Communication
  • Effective Presentation of Statistical Risk Information

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The Pharmacovigilance Quality Management System

Featured Topics:

  • Structures and processes of a quality system and a pharmacovigilance system
  • Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Quality Manual requirements, content, and maintenance
  • Safety Data Exchange Agreements (PV Agreements) across clinical study programs and post-marketing, including the development, regulatory requirements, and quality oversight
  • Recommendations for Pharmacovigilance System Inspection Readiness
  • Design of strategy and methodologies for Risk Based Audits
  • Corrective and Preventative Action (CAPA) Plan preparation and effectiveness checks

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Safety Risk Management: A Focus on EU RMPs and US REMS

Featured Topics:

  • Guidelines and regulations for RMPs and REMS
  • Core elements of an EU-RMP and REMS, and associated templates
  • Terminology used in risk management programs
  • Safety risk management processes, including roles and responsibilities of risk management colleagues
  • Strategic and operational aspects of safety risk management programs

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Real-World Evidence On-Demand Training

Featured Topics:

  • The evolving regulatory landscape
  • Evolving real-world data: it's uses and determining when it is "fit for purpose"
  • External comparator analyses
  • Considering real-world evidence (RWE) in the conetxt of an integrated package of evidence

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Designing, Integrating, and Analyzing RCT/RWE in Safety Decision Making On-Demand Training

Featured Topics:

  • Evolving Landscape of Safety Evaluation
  • Signal management and Causal Assessment
  • Pragmatic Trials
  • Elements of Observational Studies
  • Safety Signal Detection
  • The Sentinel System
  • Multicourse Data
  • Analysis Methodologies

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Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

Featured Topics:

  • Japanese Pharmaceutical Market
  • Pharmaceutical Regulatory Framework in Japan
  • The "Drug Lag:" A Driver of Regulatory Reform
  • The Drug Development, Consultation, and Approval Process
  • Special Programs and Accelerated Pathways
  • Use of Real-World Evidence (RWE) and Real-World Data (RWD) for Regulatory Decisions in Japan
  • Multicourse Data
  • Analysis Methodologies

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Benefit-Risk Assessment and Management Across the Lifecycle

Featured Topics:

  • Legal and regulatory basis for benefit and risk obligations, including a historical perspective
  • Principles, basic definitions, and frameworks for compliance
  • Fundamentals of performing benefit-risk assessment
  • Importance of the patient perspective and incorporation into the benefit-risk equation
  • Risk minimization tools and the circumstances for which they are deployed
  • Measuring effectiveness of risk minimization
  • How and why the benefit-risk equation evolves over time
  • Benefit-risk assessment and selection of tools to minimize risks while maximizing benefit to the patient

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Clinical Statistics for Nonstatisticians

Featured Topics:

  • Basic statistical concepts
  • Hypothesis testing
  • Study design
  • Analysis plan
  • Statistical modeling
  • Survival analysis
  • Trial for superiority
  • Trial for equivalence

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Navigating Chemistry Manufacturing and Controls Through the Drug Development Process

Featured Topics:

  • The CMC components of INDs and NDAs/CTDs
  • Tools to write or assemble CMC sections of regulatory submissions
  • How to prepare for a successful and productive CMC meeting with FDA
  • CMC and regulatory consideration with pediatric formulations
  • FDA 483s, Warning Letters and how to avoid them
  • Preparing for a PAI
  • Navigation through the myriad guidelines and guidance documents

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Regulatory Affairs for Combination Products

Featured Topics:

  • The CMC components of INDs and NDAs/CTDs
  • Tools to write or assemble CMC sections of regulatory submissions
  • How to prepare for a successful and productive CMC meeting with FDA
  • CMC and regulatory consideration with pediatric formulations
  • FDA 483s, Warning Letters and how to avoid them
  • Preparing for a PAI
  • Navigation through the myriad guidelines and guidance documents

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Regulatory Affairs: The IND, NDA, and Post-Marketing

Featured Topics:

  • Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
  • What to expect at meetings and in other interactions with FDA
  • Regulatory Requirements of Prescription Drug Labeling and Advertising
  • Post-Marketing Requirements

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