6th European Forum for Qualified Person for Pharmacovigilance (QPPV)
|Event Date/Time: Apr 24, 2012||End Date/Time: Apr 26, 2012|
The sessions that follow include:
â€¢ QUALITY MATTERS
QPPVs will receive the latest information on the development of PSMFs, some practical advice on implementing quality systems in PV and an update on findings of interest from recent inspections.
â€¢ MANAGING THE â€˜HOUSE OF CARDSâ€™: HOW TO COPE WITH GLOBALISATION AND TECHNOLOGY
Hear the latest tips and share experiences.
â€¢ CURRENT TRENDS
This session will explore the challenges posed and opportunities presented for pharmacovigilance by new technologies such as social media.
â€¢ EU LEGISLATION: STRONGER, MORE EFFICIENT AND MORE TRANSPARENT? BUT WHERE DOES THE QPPV FIT IN?
Put your questions to an expert panel.
â€¢ MOVING FROM SAFETY REPORTING TO BENEFIT: RISK EVALUATION
An overview of the main changes in and insights on benefit/ risk and signal detection activities.
â€¢ BENEFIT/RISK MANAGEMENT
Regulators and industry reveal how the science of post-authorisation effectiveness measurement has progressed and its impact on the QPPV's oversight of the pharmacovigilance system.
â€¢ CHALLENGES OF CHANGING LEGISLATION ON OVERSIGHT ROLE OF THE QPPV
- Receive specific examples of current divergence in expectation at the national level
- Discuss how a QPPV can best monitor for and address any varying expectations as the upcoming implementation progresses
- Explore whether or not the QPPV will need new skills/training in the new world.
â€¢ European Qualified Persons for Pharmacovigilance
â€¢ Deputy Qualified Persons
â€¢ Senior Pharmacovigilance Regulators and Inspectors
â€¢ CRO and Consultants providing QPPV Services
â€¢ National Responsible Persons for Pharmacovigilance