• Tracking a case from start to finish
• Assessing cases
• Reference safety information
• Harmonization initiatives
• Important US and EU regulations
• Individual case reporting
• Aggregate reporting
• Risk assessment
• Benefit-risk assessment
• Risk management plans
• Risk evaluation and mitigation strategies (REMS)
• Safety signal basics
• Data mining
• Pharmacoepidemiology
• Types and scope of audits and inspections
• Common inspection findings
• Responding to an inspection
• Corrective and preventative action plan

These modules are designed for professionals involved in:

• Drug safety and pharmacovigilance
• Clinical research and development
• Quality assurance and compliance
• Regulatory affairs
• Medical affairs
• Marketing

Module 1: Introduction to Drug Safety: Upon completion of this module, learners should be able to:

• 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
• Determine the assessment of seriousness, expectedness, and causality of adverse events

Module 2: Drug Safety Regulatory Requirements: Upon completion of this module, learners should be able to:

• Identify key harmonization initiatives and important US and EU regulations
• Recognize the roles that the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Council for International Organizations of Medical Sciences (CIOMS) play in drug safety regulations
• Define good clinical and pharmacovigilance practices and standard operating procedures (SOPs) that support drug safety

Module 3: Pre-Marketing Clinical Trial Safety: Upon completion of this module, learners should be able to:

• 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 marketing application
• Define risk assessment in clinical trials

Module 4: Post-Marketing Safety Management: Upon completion of this module, learners should be able to:

• 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: Upon completion of this module, learners should be able to:

• Define a safety signal and list the activities in signal management
• List different safety databases and the information each contains
• 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 CIOMS VIII principles for signal detection

Module 6: Safety Audits and Inspections: Upon completion of this module, learners should be able to:

• Identify FDA inspections, possible sanctions, and how a company should respond to an FDA inspection, including the Corrective and Prevention Action (or CAPA) Plan
• Differentiate European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) inspections, the legal basis for European inspections, the new European guidelines on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
• Recognize Health Canada safety inspections and after-inspection activities
• 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