Pharmacovigilance Blog
Recent articles, news, information and announcements related to Pharmacovigilance industry.
PRAC adopts Pharmacovigilance Impact Strategy
March 9, 2016 by Moin Don
PRAC adopts pharmacovigilance impact strategy At its January 2016 meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) adopted the ‘Strategy on Measuring the Impact of Pharmacovigilance Activities’. The new Strategy details how to gather data and knowledge on the concrete effect of measures and processes meant to ensure the safe use of medicines […]
Categories: PharmacovigilanceFDA releases draft guidance “Providing Submissions in Electronic Format – Postmarketing Safety Reports”
June 14, 2014 by Moin Don
US FDA has released a new draft guidance providing information on the electronic submission of postmarketing safety reports (ICSRs), attachments to ICSRs and other postmarketing safety reports. This draft guidance revises and replaces the draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format
Categories: Pharmacovigilance | Tags: Regulations