Assuring Best Practice in Signal Detection & Management for GVP

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By: SMi Group
 
 
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April 5, 2013 - PRLog -- In order to administer a more effective analysis for signal detection Market Authorization Holders (MAH) will be required to monitor the EudraVigilance database according to their level of access and shall be based on a multidisciplinary approach. Healthcare Tech Buzz reported GVP Module IX outlines how data should be assessed by a Qualified Person in a "timely" manner, how the process should be documented and how urgent action should be taken whenever a safety issue arises.

Under the guidance of Nawab Qizilbash, Head of Oxon Epidemiology Team. This interactive session will explore implementation, quality and auditability of signal detection.  full-day masterclass will provide attendees with an in-depth insight into signal detection and will cover compliance with the new EU GVP legislation and how to apply this to the new PSUR.

Registered Delegates Would Benefit From
Appreciate the requirements of the new EU legislation (GVP) for signal detection
Application of signal detection to the new PSUR
How to make signal detection traceable and auditable
Describe the role of statistical signal detection in the new GVP
Understand the principles and practice of statistical signal detection & evaluation
Learn how other companies implement statistical signal detection
Discuss how to implement/optimise statistical signal detection strategies in your company for GVP
Learn from real-life case studies and exercises

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For more information, visit: www.smi-online.co.uk/signal-detection.asp (http://www.smi-online.co.uk/goto/bestpractice-psur.asp?em...)
Alternatively, contact Cem Tuna Tel: +44 (0)20 7827 6736/ ctuna@smi-online.co.uk
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Source:SMi Group
Email:***@smi-online.co.uk Email Verified
Tags:Signal Detection, GVP, Pharmacovigilance, PSUR, EU legislation
Industry:Health, Medical
Location:England
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