EU SCOPE Project Will Harmonize Pharmacovigilance, Benefit Industry
This article was originally published in The Pink Sheet Daily
Executive Summary
The EU SCOPE pharmacovigilance project will harmonize practices across the 28 member states, thereby cutting the administrative and cost burden for pharmaceutical manufacturers.
You may also be interested in...
European Notebook Notes Arrival Of CHMP Minutes And Biosimilar MAbs
CHMP has released for the first time the minutes of its meeting, and EMA has set up a new pharmacovigilance cluster with the FDA. A biosimilar infliximab product from Hospira and Alvogen has become the first biosimilar monoclonal antibody launched in Europe.
European Generics Applications Fall, As EMA’s Interim Report Hopes To Herald Funding Renewal
European Commission intervention has stopped duplicate generic applications. EMA hopes to end its budget row with the EU Parliament by focusing on transparency and conflict of interest disclosures.
Lacking "Mediator," EC Tightens Pharmacovigilance Proposals
European Commission's surprise update of the pharmacovigilance rules is included in its review of the information to patients legislation, but industry's biggest concern may be the failure to address the role of social media.