WORKING WITH
INVESTIGATORS AND
CLINICAL SITES TO
OBTAIN QUALITY
PRE-MARKETING SAFETY
DATA

Conference Date: 25 Nov 2008
Conference Ref: A11-4608
Venue: The Rembrandt Hotel, London

Key topics to be covered:

• Factors that affect adverse event reporting in premarketing clinical trials and postmarketing pharmacovigilance
• Importance of active query and clinical pharmacological principles in quality assessment of premarketing ICSRs
• Successful application of interventions designed to stimulate health professional reporting and foster higher quality reports in postmarketing pharmacovigilance to premarketing clinical trials
• How to craft effective case narratives
• Working with clinical investigators and clinical sites – lessons learned
• The relationship between quality integrated summaries of safety and quality risk management 
• Recognize impact of the EU’s Volume 9A
• Understand postmarketing pharmacovigilance inspections in the US and EU

Please see PDF brochure above for further details or email sarah@management-forum.co.uk.