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Pharmacovigilance in the European Union: A Guide to New Directives

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Inspections and Audits

Product Details

Navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life.

In order to stay compliant in the EU’s complicated regulatory environment drugmakers must know:

  • How to gain and renew “Marketing Authorization Holder” (MAH) status
  • The role of the Pharmacovigilance Risk Assessment Committee (PRAC) in monitoring and auditing manufacturers and enforcing the pharmacovigilance rules
  • What kinds of surveillance efforts the EU expects

This report, Pharmacovigilance in the European Union, will help readers navigate the EU’s regulatory landscape by covering the following issues:

  • Periodic Safety Update Reports — what they must contain, and how frequently they must be issued

  • Marketing authorization — the difference between getting it and renewing it

  • The new rules on post-authorization efficacy studies

  • The powers of the Pharmacovigilance Risk Assessment Committee and their relationship with the Committee on Human Medicinal Products

  • The significance of the “Black Triangle”

Order Pharmacovigilance in the European Union and stay on top of the most recent EU pharmacovigilance directives.

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PDF Edition

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Who Will Benefit

  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff

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