PRLog - Feb. 28, 2013 - The upcoming pharmacovigilance legislation will have the biggest impact on the European medicines regulation since 1995. The requirements for Market Authorization Holders (MAH) in signal management are set out in GVP Module IX. It states that MAHs should extensively monitor all available data for the classification of potential safety concerns. The MHRA (2012) has stated in order to administer a more effective analysis MAHs will also need to analyse the EudraVigilance database according to their level of access and shall be based on a multidisciplinary approach.
SMi - GVP
The European Pharmacovigilance Legislation (2012) pointed out 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.
Against this backdrop, SMi Group’s timely; 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 - led by Nawab Qizilbash, Head of Oxon Epidemiology Team. This interactive session will explore implementation, quality and auditability of signal detection, as well as providing the opportunity to discuss recent case studies on how other companies are implementing compliant statistical signal detection strategies.
Delegates attending will 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
*notes to editors
Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
Marta Mariño BSc is Director of Pharmacovigilance at OXON, and brings the experience of being Head of Pharmacovigilance at Schering-Plough, Spain from 1995-2010, until the takeover by MSD. She ensures that all safety aspects of OXON’s work for clients are compliant with current regulations and auditable.
About OXON Epidemiology
OXON Epidemiology is a European full-service CRO with Asian and Latin American reach that specialises in ´real word data´(www.oxonepi.com):
To view the conference programme and full speaker line-up, visit http://www.smi-
Alternatively contact Cem Tuna on +44 (0) 20 7827 6736 or firstname.lastname@example.org