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Drug Safety eLearning Program

The Drug Safety eLearning Program provides the knowledge you need, from regulations and requirements through pre-market review and post-market 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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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 Post-marketing 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: Pre-Marketing 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
  • Pre-marketing Review of Safety Data in a Marketing Application

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Module 4: Post-Marketing 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
  • Post-marketing 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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Drug Safety eLearning Bundle

Modules included:

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Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies

Featured Topics:

  • Toxicology
  • Clinical Pharmacology
  • Pharmacogenomics
  • Pharmacoepidemiology

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Selecting and Managing Outsourced Safety Providers

Featured Topics:

  • The Current and Future Landscape of Pharmacovigilance
  • Defining a Safety Program's Needs
  • Outsourced Safety Providers
  • Transfer of Responsibilities
  • Offshoring and Outsourcing
  • Risks and Issues
  • Developing an Outsourced Safety Program
  • Internal Assessment
  • Planning a Business Outsourcing Model
  • Successful Selection of an Outsourced Provider
  • The Sponsor and Contract Service Provider Relationship
  • Safety Outsourcing Provider Management
  • Pharmacovigilance Inspection Programs; Inspections in US, EU, and UK
  • Inspection Findings

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