Complying With the New EMA Pharmacovigilance Rules
Tuesday, July 29, 2014 • 1:30 p.m. - 3:00 p.m. EDT
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:
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.