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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 modules 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
  • 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

Who should attend?

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.

Learning objectives

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