Pharmacovigilance in the EU - Webinar CD/Transcript

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Pharmacovigilance in the EU: Expert Guidance on the Latest Rules and Directives

New EU directives were put in force in 2012 and compliance has become an issue. Last year saw 19 companies cited for “critical pharmacovigilance failures.” New directives were also recently adopted on postmarket studies as well as a rule on monitoring medical literature.

What can you do?

Join Elisabethann Wright, BL — partner in the Brussels, Belgium office of Hogan Lovells International — for a 90-minute session discussing current EU rules.  She will cover 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”
  • The EMA’s “GVPs” — Good Pharmacovigilance Practices — 12 parts out already, 3 more expected this year

Order today and stay on top of the most recent EU pharmacovigilance directives.

  • 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

Elisabethann Wright, BL is a partner in the Brussels, Belgium office of Hogan Lovells International.  Her experience is in the area of European law and has included both periods in private practice and periods working with international institutions. She focuses on European Union (EU) law relating to life sciences, with particular emphasis on pharmaceutical law, medical devices, food law and the environment.