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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum


Overview

This comprehensive three day training course is designed to cover contemporary principles, definitions, regulatory expectations, and pragmatic approaches to drug safety and pharmacovigilance in key regulatory jurisdictions, with focus on the US and EU. Topics will span the life cycle of traditional innovative medicinal products, from first-in-human through the postmarketing phase. However, faculty will be prepared to discuss drug safety topics of interest to participants. The course will be delivered in a series of sessions at a basic to intermediate level; didactic presentations will be supplemented with real-world case studies and practical exercises. Active discussion with experienced faculty will be encouraged and the agenda will provide ample opportunities for Q&A.

What you will learn

  • 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
  • Data collection, processing, and requirements in the postmarketing phase, including MedDRA coding, safety query development, and evolving EU 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)

Who should attend?

This program is designed for entry to 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

This training course is also designed to provide a comprehensive foundation for those:

  • Seeking to broaden their role within premarket or postmarket safety and pharmacovigilance functions,
  • Seeking a career change into safety/pharmacovigilance function, or
  • In related disciplines that interact with or support safety and pharmacovigilance function across the product life cycle

Learning objectives

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