SUN.eVeille Safety - Useful Resources

Clinical Safety & Pharmacovigilance Intelligence Review

The following documents have been introduced in SUN.eVeille Safety:

PV Focus presentation: "How to set-up a Pharmacovigilance QA? - Early detection of risks and theirmanagement in Clinical Development "

SQA Annual Meeting  -  April 23-27, 2006 in Phoenix, AZ, USA

Session chaired by Hans Poland, Global Head of CQA, Schering AG, Germany

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PV Focus presentation: "Quality Risk Management and Auditing Pharmacovigilance Systems"

DIA EuroMeeting  -  March 6-8, 2006 in Paris, France

Session chaired by Beat Widler, Global Head of PDQ, Roche, UK

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PV Focus article: "Auditing Pharmacovigilance – Experience and learning points"

January 2006 issue of Quasar, the journal of BARQA (British Association of Research
Quality Assurance)

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PV Focus presentation: "Impact of the EU CT Directive on Auditing Pharmacovigilance"

DIA meeting: Implementation Issues of the Clinical Trial Directive, Pharmacovigilance and Risk Management  -  September 20-21, 2005 in Brussels, Belgium

Session chaired by Beat Widler, Global Head of PDQ, Roche, UK

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PV Focus presentation: "Winds of Change - Pharmacovigilance Inspections in the EU "

DIA meeting: Implementation Issues of the Clinical Trial Directive, Pharmacovigilance and Risk Management  -  September 20-21, 2005 in Brussels, Belgium

Session chaired by Michael Bean, Senior Pharmacovigilance Inspector, MHRA, UK

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PV Focus presentation: "Clinical Trials Pharmacovigilance and Risk"

BARQA Good Pharmacovigilance Practice Forum  -  June 29, 2005 in Birmingham, UK

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MHRA Document: "Summary of Pharmacovigilance Systems (SPS) "

Version 1 (Final), September 2005

>> Access SPS