PV and Safety Data Management


The primary purpose of new drug development is to ensure drug safety and efficacy. As developers and market authorization holders (MAHs), pharmaceutical companies should monitor and manage the safety of the drugs throughout their lifecycle. Pharmacovigilance (PV) constitutes an important part of drug safety and quality management during its life cycle and an important means to ensure patient medication safety.

This module will provide a comprehensive analysis of Pharmacovigilance timing and purpose, and examine examples of well-developed PV systems. Special attention is given to local PV regulatory requirements. Outsourcing PV service is a good choice for many pharmaceutical companies, and this module will explore how to formulate a PV outsourcing strategy.

ワークショップ Objective

  • Understand the purpose and significance of PV throughout the drug development cycle
  • Learn key elements in establishing and/or improving a drug safety/PV system that meets local regulatory requirements

Workshop Outline

  • Drug safety during the clinical trial
  • PV and risk management
  • Important considerations in establishing a drug safety/PV system under local regulations
  • Formulate outsourcing PV service strategy
プログラム| Global Clinical Development Strategy Workshop Series