Complying With the New EMA Pharmacovigilance Rules

Complying With the New EMA Pharmacovigilance Rules - Webinar CD/Transcript

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Complying With the New EMA Pharmacovigilance Rules: Filling the Obligations Without Committing Off-Label Violations

Drugmakers for the first time must now report adverse drug reactions (ADRs) caused by their products in all uses — including off-label use.

One major question is how drugmakers fulfill those pharmacovigilance obligations while not inadvertently supporting off-label promotion.

In the webinar CD and transcript, FDAnews and EU law expert Elisabethann Wright, a partner in Hogan Lovells’ Brussels, Belgium office, will provide answers and in-depth information including:

  • Top concerns regarding the obligations imposed by the new legislation and the way they have been interpreted by the EMA and national authorities and how they will impact their company
    • Understanding the practical concerns arising from the requirement to report ADRs occurring during off-label use
    • How to respond to the potential influx of ADRs from patients
  • Ongoing implications of the new legislative obligations for companies’ pharmacovigilance systems — what companies are still struggling with and best practices for compliance.

It's always a slippery slope for drug manufacturers whenever requirements touching on off-label use are updated.

Order this 90-minute webinar CD and transcript to be certain you understand the new EMA pharmacovigilance requirements — and to ensure that your company will remain protected from any potential problems with off-label use or promotion.

  • Pharmacovigilance officers
  • Drug safety officials
  • Medical directors
  • Compliance officers
  • Executive management
  • General/corporate counsel
  • Risk management specialists
  • Academic researchers

Elisabethann Wright, a partner in Hogan Lovells’ Brussels, Belgium office is deeply experienced in the area of European Union law.  She has previously worked in private practice and 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 data privacy obligations.

She also challenges national authority and EU Institution decisions concerning classification and marketing of medicinal products and medical devices.