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Drug Safety Online Learning

Safety and pharmacovigilance are key activities for ensuring that the right products get to patients at the right time with the right balance of benefits and risks.

Optimizing benefit-risk is an important matter not just for regulators, but for all stakeholders, and planning for pharmacovigilance activities and appropriate evidence gathering must be done throughout the medicine lifecycle. DIA Learning provides safety and pharmacovigilance professionals with the knowledge needed, from regulations and requirements, to pre-market and post-market monitoring, to stay afloat in the ever-changing world of healthcare.

DIA Online learning 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 online modules.

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DIA’s Safety and Pharmacovigilance Certificate Program is a competency-based program.

This comprehensive program is based on the DIA Safety and Pharmacovigilance Competency Framework developed with experts working in the field. These competencies outline the functional knowledge and skills needed to work in safety and pharmacovigilance and comply with US and EU regulations. The Certificate Program is designed for individuals new to the field, for those with one to three years of experience, or for those looking to broaden their expertise in this area. The purpose of the program is to provide the knowledge and skills safety professionals need to succeed in their role, as well as to provide a learning pathway that allows individuals to further develop and advance their career. The safety competencies may also be leveraged by leaders in the industry to help build safety teams and develop their employees.

Participants will earn digital credentials as they continue along the Learning Path, ultimately culminating in the granting of the DIA Safety and Pharmacovigilance Certificate and corresponding digital credential. The certificate term is for life.

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Explore the Program, Watch a Short Video!


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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Related Content

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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