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This basic to intermediate-level course focuses on pharmacovigilance of traditional medicinal products intended for human use. Topics will span investigational and marketed products in clinical trials, post-marketing studies, and under conditions of actual use in real-world health care settings.  Late breaking regulatory changes, pertaining to the EU will be presented.  Attendees will gain a detailed understanding of safety and pharmacovigilance obligations and best practices.
Course Level: Intermediate

What you will learn

  • Legal basis for safety reporting including a historical perspective
  • Basic definitions and tools
  • Evaluation of seriousness, expectedness, and causality
  • Safety reporting requirements in the pre-marketing phase
  • Data collection, processing, and requirements in the post-marketing phase
  • Case studies and practical exercises
  • Active safety surveillance in the post-marketing phase
  • Audits and inspections
  • Introduction to signal detection and risk assessment
  • Basics of risk management in the US and EU
  • Principles of pharmacoepidemiology

Who should attend?

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

  • Clinical safety/pharmacovigilance
  • Medical writing
  • Marketing

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 from first in human studies through the post-marketing phase
  • Demonstrate an awareness of risk management principles and pharmacoepidemiology