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Overview

Learn about the fundamentals of clinical drug safety and the key tools available for postmarketing pharmacovigilance. Discuss the application and inter-relationships of these tools, and consider future directions for the field. Gain knowledge of the latest changes in the US and EU regulations and best practices for compliance. Develop an in-depth understanding of the requirements and procedures that must be performed to protect patient safety and to remain in compliance with legal obligations in two key regulatory jurisdictions. Didactic presentations will be supplemented with case studies and practical exercises to reinforce learning. There will be ample time for Q&A with the faculty.

Course Level: Intermediate

What you will learn

  • The origins and evolution of drug safety, including consensus groups, key legislation, global standards, and how to speak the language of pharmacovigilance
  • US and European postmarketing pharmacovigilance requirements, with a focus on traditional medicines and therapeutic biologicals
  • Pragmatic approaches to individual case processing and aggregate data submissions
  • Information technology, data protection needs, and ethical issues associated with drug safety
  • The basics of drug safety inspections, including case studies
  • The anticipated future direction of travel for post-marketing pharmacovigilance requirements

Who should attend?

Professionals who work in:

  • Global drug safety, pharmacovigilance, and risk management
  • Regulatory or legal affairs
  • CROs, start-ups, small companies, or generic drug companies
  • SOP development or quality systems
  • Areas responsible for training and teaching of drug safety and pharmacovigilance 
  • Clinical health care
  • Out-licensing or in-licensing of biopharmaceutical products
  • Outsourcing or off-shoring of drug safety activities
  • Supervisory capacities in drug safety or functions related to pharmacovigilance
  • Patient advocates

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 legal and regulatory basis of postmarketing drug safety and pharmacovigilance
  • Explain the requirements, changes, pitfalls and risks in postmarketing pharmacovigilance, and apply the knowledge gained in your daily pharmacovigilance functions
  • Describe the drug safety system and what is involved and expected in an audit or governmental inspection
  • Describe how your pharmacovigilance system will perform on an audit or governmental inspection