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SESSION 2: OPERATIONAL EXPERIENCE WITH EUDRAVIGILANCE (PART II)
Session Chair(s)
Sabine Brosch, PHARMD, PHD, MPHARM
Data Protection Officer
European Medicines Agency, Netherlands
Anja Van Haren, MSC
Eudravigilance coordinator
Medicines Evaluation Board (MEB), Netherlands
This session provides the opportunity to discuss with an expert from a national Competent Authority the simplified reporting rules and frequently identified issues related to ICSRs reported by marketing authorisation holders. Furthermore, key topics discussed by the Pharmacovigilance Business Team as regards procedural and regulatory aspects will be highlighted. The session will conclude with a dedicated question and answer session for which participants are invited to send questions by 23 February 2018 to emaevents@diaglobal.org
Speaker(s)
The new EudraVigilance system – the experience from an NCA perspective
Mona Vestergaard Laursen, MPHARM
Danish Medicines Agency, Denmark
Senior Advisor, Data Analytics Centre
Dos and Don’ts in using EudraVigilance
Anja Van Haren, MSC
Medicines Evaluation Board (MEB), Netherlands
Eudravigilance coordinator
Questions & Answers
Tom Paternoster-Howe, MSC
European Medicines Agency, Netherlands
Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data
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