• 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 pre-marketing, peri-approval, and post-marketing continuum  
• Evaluation of seriousness, expectedness and causality
• Data collection, processing, and requirements in the post-marketing 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 lifecycle

Broadening their role within pre-market or post-market 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 post-marketing safety
• Evaluate 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
• Cite the criteria and elements of expedited and periodic reporting of drug safety information from first-in-human studies through the post-marketing phase
• Define of risk management and signal detection principles