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Drug Safety eLearning Program

Drug safety is a primary concern throughout the medical product development life cycle. Developed with DIA expertise to meet the unique needs of its stakeholders and members, the Drug Safety eLearning Program* provides the knowledge you need, from regulations and requirements through premarket review and postmarket monitoring.  The online program includes six self-paced modules that can be accessed 24 hours a day, 7 days a week. Modules do not have to be taken in one sitting; users can start/stop at any time and begin where they left off. Users will have one year to complete the modules and continuing education credits are offered. The modules can be purchased individually at $400 each, or save 20% today by purchasing all six modules.

Approved by the Regulatory Affairs Professionals Society for 6 RAC credits.

Explore the Drug Safety eLearning Program, Watch a Short Video!

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.

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* 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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