• Drug Safety Basics
• Terminology
• A Company Safety Unit
• Tracking a Case from Start to Finish
• Reference Safety Information
• Assessing Cases
• Harmonization Initiatives
Important US Regulations
• Important EU Regulations
• 2010 EU Pharmacovigilance Reform
• Global Safety Regulatory Resources
• Pharmacovigilance Documentation Practices
• Standard Operating Procedures
• Clinical Trial Subject and Data Oversight
• Individual Case Reporting
• Aggregate Reporting
• Risk Assessment
• Pre-Marketing Review of Safety Data in a Marketing Application
• Spontaneous Reporting
• Spontaneous Reporting Case Study
• Benefit-Risk Assessment
• Risk Management Plans in the EU
• Risk Evaluation and Mitigation Strategies(REMS) in the US
• Post-Marketing Safety Management Examples
• Safety Signal Basics
• Safety Databases
• Data Mining and the Use of Statistics in Drug Safety
• Principles of Pharmacoepidemiology
• Signaling Regulations and Guidances
• Introduction to safety audits and inspections
• FDA inspections
• EMA and MHRA inspections
• Health Canada inspections
• Inspection findings
• Responding to an inspection
• Best practices for managing audits and inspections

These modules are designed for professionals involved in:

• Clinical safety and pharmacovigilance
• Clinical research
• Regulatory affairs
• Medical writing
• Marketing
• Quality assurance
• Compliance
• Epidemiology
• Outcomes Research
• Biostatistics
• Bioinformatics
• Health and economic outcomes research

At the conclusion of each corresponding module, participants should be able to: 

Module 1: Introduction to Drug Safety

• Recognize the history, principles, and regulatory framework for clinical drug safety
• Define terms used in day- to-day pharmacovigilance work
• Identify a typical company drug safety unit and the path of a case from start to finish
• List Reference Safety Information provided by the Investigator's Brochure and post-marketing labeling
• Evaluate the seriousness, expectedness, and causality of adverse events



Module 2: Drug Safety Regulatory Requirements

• Differentiate between key harmonization initiatives and important US, EU and other regional regulations
• Recognize the roles of major organizations and authorities involved in drug safety, including ICH, CIOMS, FDA, and EMA
• Identify requirements introduced by the EU pharmacovigilance reform
• Recognize good clinical and pharmacovigilance practices and standard operating procedures that support drug safety

Module 3: Pre-Marketing Clinical Trial Safety

• Identify the purpose and elements of informed consent in clinical trials
• Determine the roles of institutional review boards, ethics committees, and data and safety monitoring boards in clinical trials
• Recognize pre-marketing individual case reporting, aggregate reporting requirements, and review of safety data in a marketing application
• Define risk assessment in clinical trials

Module 4: Post-Marketing Safety Management

• Define spontaneous reporting and describe the spontaneous reporting system
• Identify the requirements for aggregate reporting of adverse events in marketed products
• Recognize the presentation of risks required in US labeling and the efforts that have been made internationally to standardize benefit-risk assessment in the post-marketing phase
• Compare risk management plan requirements in the EU with risk evaluation and mitigation strategies (REMS) that are required in the US during post-marketing

Module 5: Basics of Signal Detection and Pharmacoepidemiology

• Define a safety signal and list the activities in signal management
• List safety databases and information contained in each database
• Recognize the use of statistics in drug safety, data mining, and their role in signal detection
• Define pharmacoepidemiology and explain its role in drug safety management
• Identify signaling regulations and guidances in the US and EU, and Council for International Organizations of Medical Sciences (CIOMS) VIII principles for signal detection

Module 6: Safety Audits and Inspections

• Identify inspections, possible sanctions, and how a company should respond to an FDA inspection, including the Corrective and Preventive Action (or CAPA) Plan
• Differentiate between the inspection processes of the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada
• Recognize the legal basis for European inspections, the European pharmacovigilance inspection guidelines, the MHRA’s risk-based approach, and the possible sanctions for non-compliance
• List inspection findings common to both FDA and MHRA, and to each agency individually
• Determine best practices for the company’s management of audits and inspections