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