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Drug Safety eLearning Program

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Drug Safety eLearning Program (all six modules!)

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.

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*15% off promotion excludes the DIA Medical Affairs eLearning modules and program.


Module 1: Introduction to Drug Safety

Featured Topics:

  • Drug Safety: The Basics
  • Terminology
  • A Company Safety Unit
  • Tracking a Case from Start to Finish and Assessing Cases
  • Reference Safety Information: The Investigator's Brochure and Postmarketing Labeling
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Module 2: Drug Safety Regulatory Requirements

Featured Topics:

  • Harmonization Initiatives
  • Important US and EU Regulations
  • 2010 EU Legislation
  • Good Safety Regulatory Resources
  • Good Pharmacovigilance Practices: Documentation
  • Standard Operating Procedures
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Module 3: Premarketing Clinical Trial Safety

Featured Topics:

  • Informed Consent
  • Institutional Review Board and Ethics Committee
  • Data and Safety Monitoring Boards
  • Individual Case Reporting and Aggregate Reporting
  • Clinical Trial Safety Case Study Activity
  • Risk Assessment
  • Premarketing Review of Safety Data in a Marketing Application
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Module 4: Postmarketing Safety Management

Featured Topics:

  • Spontaneous Reporting
  • 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
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Module 5: Basics of Signal Detection and Pharmacoepidemiology

Featured Topics:

  • Safety Signal Basic and Safety Databases
  • Data Mining and the Use of Statistics in Drug Safety
  • Principles of Pharmacoepidemiology
  • Signaling Regulations and Guidances
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Module 6: Safety Audits and Inspections

Featured Topics:

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

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