• Legal basis for safety obligations, including an historical perspective
• Principles, basic definitions, and pragmatic approaches for compliance
• Basics of Individual Case Safety Reports (ICSRs) and periodic reports (DSUR, IND AR, PADER, PSUR/PBRER) in the premarketing, peri-approval, and postmarketing continuum  
• Evaluation of seriousness, expectedness, and causality
• An introduction to benefit-risk assessment
• The safety framework in the premarketing phase, including Investigator, IRB/EC, and Sponsor roles under an IND
• The mathematics of drug safety 
• Regulator approaches to marketing dossier review
• Basics of risk management planning, EU Risk Management Plans, and Risk Evaluation and Mitigation Strategies (REMS)
• Data collection, processing, and requirements in the postmarketing phase, including MedDRA coding, safety query development, and evolving EU requirements
• Active safety surveillance in the postmarketing phase
• Introduction to signal detection
• Principles of pharmacoepidemiology
• Audits and inspections

Professionals working in pharmaceutical industry, academia, and drug regulatory authorities with basic to intermediate level experience in:

• Clinical safety/pharmacovigilance
• Case processing
• Interventional clinical trial personnel (e.g., clinician, Principal Investigator, Medical Monitor, Clinical Research Associate, pharmacist, Electronic Data Capture tools)
• Sponsor planning and oversight of clinical development programs, including regulatory approach, protocol design, and program implementation
• Medical writing
• Marketing, including Disease Management and Customer Engagement Programs
• Quality systems
• Regulatory strategy
• Risk management planning and development of formal Risk Management Plans
• Independent Data Safety Monitoring Board

This training course is also designed to provide the basics for those seeking a career change into a pharmacovigilance function.

At the conclusion of this activity, participants should be able to:

• Identify the history, principles, and regulatory framework for clinical drug safety
• Discuss the basic definitions of terms used in day-to-day pharmacovigilance work
• Recognize basic international regulatory requirements for safety surveillance, as well as those requirements specific for the US and EU
• Describe the criteria and elements of expedited and periodic reporting of drug safety information from first-in-human studies through the postmarketing phase
• Demonstrate an awareness of risk management principles and pharmacoepidemiology