Complying With the New EMA Pharmacovigilance Rules

Webinar Details

whenWhen?  Tuesday, July 29, 2014
whereWhere? Your Office
whenTime? 1:30 p.m. - 3:00 p.m. EDT


Webinar plus Audio CD/Transcript $487
Webinar only $287
24/7 Encore plus CD/Transcript $487
24/7 Encore Presentation $287
Audio CD/Transcript $287

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 a July 29, 2014 webinar, 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.

So, register for this 90-minute webinar NOW 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.