• Legal and regulatory basis for safety obligations, including a 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
• Data collection, processing, and requirements in the postmarketing phase, including MedDRA coding, safety query development, and evolving regulatory requirements
• Overview of case processing and organization of a typical safety department
• Safety audits and inspections
• Introduction to signal detection
• Introduction to benefit-risk assessment
• Basics of risk management planning, EU Risk Management Plans, and Risk Evaluation and Mitigation Strategies (REMS)

This program is designed for entry through intermediate level professionals involved in:

• Drug safety/pharmacovigilance
• Adverse event reporting
• Case processing
• Safety evaluation
• Periodic safety reporting
• Medical monitoring
• Quality systems
• Regulatory strategy, regulatory affairs
• Risk management planning and development of formal Risk Management Plans and REMS
• Disciplines that interact with or support safety and pharmacovigilance functions across the product life cycle

Broadening their role within premarket or postmarket safety and pharmacovigilance functions

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

• Identify the history, principles, and regulatory framework for clinical trials and postmarketing 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 and signal detection principles