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Overview

Learn the key tools available for pharmacovigilance, discuss their uses, and consider the future directions of the field. Gain knowledge of latest changes in the US and EU regulations and best practices will be discussed.  You will gain a detailed understanding of the requirements and procedures that must be performed in order to remain in full compliance with legal obligations.

Course Level: Intermediate

What you will learn

  • How to make your pharmacovigilance program more efficient and compliant
  • US, European, and other global requirements and standards in drug safety and pharmacovigilance
  • Privacy, information technology, and data protection issues involved in drug safety
  • How to speak the language of drug safety, signaling, risk management and pharmacovigilance
  • Future of drug safety and pharmacovigilance
  • The basics of drug safety inspection

Who should attend?

Professionals who work in:

  • Global drug safety, pharmacovigilance, and risk management
  • Regulatory and legal affairs
  • CROs, start-ups, small companies, generic drug companies and anyone needing to get up to speed rapidly on the basics of drug safety and pharmacovigilance
  • Training and teaching of drug safety and pharmacovigilance
  • Clinical health care
  • New drug development
  • Outsourcing and offshoring of drug safety
  • Supervising and dealing with drug safety

Learning objectives

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

  • Identify the legal and regulatory basis of postmarketing drug safety and pharmacovigilance
  • Describe how your drug safety system will perform on an audit or governmental inspection
  • Explain the requirements, changes, pitfalls and risks of drug safety and pharmacovigilance, and apply the knowledge gained in your daily pharmacovigilance functions
  • Describe your company’s drug safety system and determine whether it is meeting regulatory compliance needs and requirements

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