Successful signal detection and management are the foundations of pharmacovigilance practice. Statistical signal detection is being widely used to improve the internal efficiency of PV departments and to remain compliant. Signals should follow a process of validation, prioritisation and assessment, and an audit trail of activities should be kept as part of the quality management system.
This masterclass hosted by OXON Epidemiology will provide delegates with essential information on the theory and practice of statistical signal detection, with practical examples, principally for small and medium sized originator and generic pharmaceutical companies. Delegates will learn how other companies have implemented statistical signal detection and discuss implementation in their own companies.
Key benefits to this masterclass are:
• Appreciate the requirements of the EU legislation (GVP) for statistical signal detection
• Learn how to make any statistical signal detection traceable and auditable
• Learn how other companies implement statistical signal detection alongside qualitative signal detection
• See a demonstration of statistical detection software
• Learn from real-life case studies and exercises
Speakers: Dr Nawab Qizilbash, Head, Geriatrician and Epidemiologist, Oxon Epidemiology, Dr Sabine Straus, Staff Member of the Medicines Evaluation Board, Utrecht and PRAC Member.
From: April 15, 2014 09:00
To: April 15, 2014 17:30
Holiday Inn London - Bloomsbury, Coram St, WC1N 1HT, London, GB