EU Pharmacovigilance

EU Pharmacovigilance - Webinar CD/Transcript

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EU Pharmacovigilance: Impact of the New Regulation

More than 15 significant new pharmacovigilance requirements have been introduced in the EU in the past year.  Many changes will require drugmakers to make process changes and have prompted such questions as:

  • How is the newly formed PRAC operating?
  • What impact will the new PRAC, Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report (PSUR/PBRER) and Risk Management Plan (RMP) requirements have on your operations?
  • How will changes in the legislation affect the way product assessment is carried out in both pre- and post- authorization phases?
  • How will CMDh and other committees interact with the PRAC?
  • Will the black symbol requirements radically change your product information processes?

For answers to these questions and more….

FDAnews and noted EU pharmacovigilance expert Elisabethann Wright of Brussels-based Hogan Lovells teamed up to provide an update on the status of pharmacovigilance in the EU.

In 90 minutes, Ms. Wright guides you through the most immediate changes and the layers of regulation to focus on the key requirements.

This is not taught in regulation-speak, or legalese.  Ms. Wright provides listeners with real world and easy-to-use guidance that makes the regulations understandable.

Everyone in your organization with a role in pharmacovigilance — clinical safety, medical affairs and regulatory affairs — should take part in this event and they can do so at a cost that won’t break the budget. You pay a single low registration fee per phone line, regardless of how many participate. So spread the word.

  • Medical affairs officers
  • Regulatory affairs professionals
  • In-house regulatory specialists
  • External regulatory specialists 
  • Lawyers responsible for pharmacovigilance
  • Medical directors/medical affairs specialists
  • Global clinical safety and pharmacovigilance officers

Elisabethann Wright, BL, is a partner in the Brussels, Belgium, office of Hogan Lovells International.  Her experience in the area of European law 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. This includes assisting clients in classification of their products, establishment of a pathway to authorization and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals and challenges to national authority, and EU Institution decisions concerning classification and marketing of medicinal products and medical devices.