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Learn how to comply with evolving US and European regulations for clinical safety during product development that are changing how we approach our daily jobs.
Course Level: Intermediate

What you will learn

  • Fundamental concepts of clinical drug safety and pharmacovigilance and their application to clinical development, with a focus on traditional small molecules
  • How to avoid common pitfalls in complying with FDA and European clinical safety regulations
  • What to expect in a preapproval safety inspection
  • Proven concepts of premarketing risk assessment and their important role in drug development
  • How to effectively use signaling tools and techniques to support premarketing risk assessment

Who should attend?

Professionals involved in:

  • Clinical safety and pharmacovigilance
  • Clinical development, including sponsors and investigators
  • Regulatory affairs
  • Quality management
  • Clinical data management

Learning objectives

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

  • Discuss why premarketing clinical safety and pharmacovigilance are important to ensure Good Pharmacovigilance Practice
  • Explain the key requirements and differences in FDA and European regulations for premarketing clinical safety and pharmacovigilance
  • Explain concepts of a preapproval clinical safety inspection
  • Develop company policies and procedures for clinical safety
  • Explain how premarketing risk assessments are performed