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Recorded Webinar
The new concept of Effective Risk Management : Are we ready for the implications of the recent changes?
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
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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