Pharmacovigilance

Pharmacovigilance for SMEs

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Meeting report: MHRA Good Pharmacovigilance Practice Symposium

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8th EGA Pharmacovigilance Discussion Forum

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Industry raises some concerns over PRACticalities of pharmacovigilance hearings

The infrastructure for holding public hearings under the EU pharmacovigilance legislation’s Urgent Union Procedure is not yet in place, but industry is nonetheless concerned about how this will work in practice. At TOPRA’s Annual European Medicines Agency Review of the Year and Outlook for 2013, companies pressed EMA officials for more information on the procedure during an update on PRAC (Pharmacovigilance Risk Assessment Committee) activities.

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