PV and Safety Data Management

コースについて

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

今日から始めましょう

私たちは、バイオ医薬品業界の専門家や幹部に対する高まる需要を満たすために、調整された、意味のある、効果的な教育およびトレーニングプログラムを開発します。当社のプログラムとカスタマイズされたトレーニングオプションの詳細を確認したり、無料の提案をリクエストしたりするには、お客様のニーズと希望する目標についてお問い合わせください。

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