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Dr. György Zörényi
MD, MFPM
Sr Patient Safety Physician
AstraZeneca UK |
| Profile |
Dr. György Zörényi, MD, MFPM, is currently a senior patient safety physician in AstraZeneca United Kingdom. He qualified from the Medical School in Budapest, Hungary and worked in Anaesthesia and Intensive Care for 8 years, including 5 years in a Heart Surgery Unit. As an assistant professor he taught anaesthesia, intensive care, cardiology and pharmacology at the Medical College of Health in Budapest and co-edited textbooks of anaesthesia, intensive care and pharmacology for health’s care professional students. He has been in pharmaceutical industry for 14 years in various roles, last 7 years in patient safety with AstraZeneca as global safety physician in established oncology. He has worked and advised on many drug safety issues including major safety hazards, due diligence and termination of clinical development. He also advised on the development of early phase and post marketing authorisation safety studies including pharmacoepidemiology studies. He has contributed to numerous PSURs, Risk Management Plans, DSURS, regulatory submissions and label changes in Europe, US and Japan.
dr. György Zörényi is a Specialist of Anaesthesiology and Pharmaceutical Medicine, Member of the Faculty of Pharmaceutical Medicine of Royal College of Physicians, United Kingdom. He is an Educational Supervisor and works in the Professional Standards Committee of the Faculty of Pharmaceutical Medicine, United Kingdom.
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| The new concept of Effective Risk Management : Are we ready for the implications of the recent changes? |
| Live Corporate Webcast |
Friday – 26th October – 2012 – 9:30 AM BST
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Duration of webcast : 1 hour | Duration of Q/A session : 10-15 mins
Post Session : Copy of Presentation Slides will be shared
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| Short
Abstract: |
This webcast presents a short summary of the new European regulation of good pharmacovigilance practice effective from 2012-2013.
The presentation will cover the following areas:
- The changed definition of adverse event and its possible implications.
- The evolution of the European- Risk Management Plan: process and structure
- The new aspects of the safety specification: how to present and define important identified and potential risks?
- The proactive versus reactive pharmacovigilance plan: how to predict/ generate/verify safety signals better?
- The measures of risk minimisation
- Post authorisation safety and efficacy studies ( PASS and PAES)
- The Integrated Benefit Risk Assessment and Periodic Benefit Risk Evaluation Report: the link with Risk Management Systems
- Benefit Risk Management Team: how to success? The best practice of cross-functional interaction
- A practical case study: paediatric indication and risk management.
Who should attend:
Personnel in the areas of Risk Management, Project Management, Pharmacovigilance, Safety, Regulatory Affairs, Budgeting and Outsourcing as well as Contract Research Organizations, Technology and Service Vendors and Consultants.
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Best Regards.
Marketing.
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