Press Release: European Medicines Agency and US Food and Drug Administration strengthen collaboration in pharmacovigilance area

The European Medicines Agency (EMA) and the United States Food and Drug Administration External link icon (FDA) have set up a new 'cluster' on pharmacovigilance (medicine safety) topics in February 2014.

Building on the experience of previous regular videoconferences between the EMA and the FDA in this area and the recent creation of the EMA's dedicated committee for pharmacovigilance, the Pharmacovigilance Risk Assessement Committee (PRAC), this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

• Primary Source

ESO: Background information: Press Release: European Medicines Agency and FDA announce launch of generic medicines application inspections initiative http://www.europeansources.info/record/press-release-european-medicines-agency-and-fda-announce-launch-of-generic-medicines-application-inspections-initiative/

ESO: Background information: Press Release: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 February 2014 http://www.europeansources.info/record/press-release-meeting-highlights-from-the-pharmacovigilance-risk-assessment-committee-prac-3-6-february-2014/

ESO: Background information: Press Release: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2014 http://www.europeansources.info/record/press-release-meeting-highlights-from-the-pharmacovigilance-risk-assessment-committee-prac-6-9-january-2014/

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