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Drug Safety eLearning Program


eLearning Online Solutions

Drug safety is a primary concern throughout the medical product development life cycle. The Drug Safety eLearning Program provides the knowledge you need, from regulations and requirements through premarket review and postmarket monitoring. This online comprehensive program includes six self-paced modules that have been designed using the latest instructional strategies including microlearning and gamification to improve retention and make learning convenient for busy professionals. Each module is broken down in to bite-sized chunks of information that can typically be consumed in 5-10 minutes increments, preventing cognitive overload and improving learning outcomes. Learners have access to the eLearning modules 24 hours a day, 7 days a week for one full year, and are mobile compatible making it easy to learn on the go! Continuing education credits are available for all modules.

Drug Safety eLearning Program (six modules)


Module 1: Introduction to Drug Safety

Featured Topics:

  • Drug Safety: The Basics
  • Terminology
  • A Company Safety Unit
  • Tracking a Case from Start to Finish
  • Assessing Cases
  • Reference Safety Information: The Investigator's Brochure and Postmarketing Labeling

Module 2: Drug Safety Regulatory Requirements

Featured Topics:

  • Harmonization Initiatives
  • Important US Regulations
  • Important EU Regulations
  • 2010 EU Legislation
  • Good Safety Regulatory Resources
  • Good Pharmacovigilance Practices: Documentation
  • Standard Operating Procedures

Module 3: Premarketing Clinical Trial Safety

Featured Topics:

  • Informed Consent
  • Institutional Review Board and Ethics Committee
  • Data and Safety Monitoring Boards
  • Individual Case Reporting
  • Aggregate Reporting
  • Clinical Trial Safety Case Study Activity
  • Risk Assessment
  • Premarketing Review of Safety Data in a Marketing Application

Module 4: Postmarketing Safety Management

Featured Topics:

  • Spontaneous Reporting
  • Spontaneous Reporting Case Study Activity
  • Aggregate Reporting
  • Benefit-Risk Assessment
  • Risk Management Plans in the EU
  • Risk Evaluation and Mitigation Strategies (REMS) in the US
  • Postmarketing Real-World Case Studies

Module 5: Basics of Signal Detection and Pharmacoepidemiology

Featured Topics:

  • Safety Signal Basics
  • Safety Databases
  • Data Mining and the Use of Statistics in Drug Safety
  • Principles of Pharmacoepidemiology
  • Signaling Regulations and Guidances

Module 6: Safety Audits and Inspections

Featured Topics:

  • Introduction to Safety Audits and Inspections
  • FDA Inspections
  • EMA and MHRA Inspections
  • Health Canada Inspections
  • Inspection Findings
  • Responding to an Inspection
  • Managing Audits and Inspections: Best Practices for Companies

Academic Credit Program

DIA and Rutgers School of Health Related Professions Biopharma Educational Initiative (Rutgers-SHRP-BEI) have partners to offer academic credit to learners completing the DIA Drug Safety eLearning course in conjunction with Rutgers online companion course.

Learn More

* The Drug Safety eLearning Program is based on DIA’s popular Drug Safety training course, Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum.

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