Addressing the key challenges for safety professionals
Day one
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| 8.50am | Opening remarks from the chair | ||
| 9am |
Keynote: In depth review of the new European pharmacovigilance legislation
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| 9.20am |
PANEL: Operational implications for integration of the new European pharmacovigilance legislation for pharma  Vicki EdwardsVicki Edwards qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. The Centre became a ... more..
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| 9.50am |
CCDS, PSUR, RMP, DSUR, signal validation: Interrelations, modules and impact of the new GVP
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| 10.20am | Morning refreshments and speed networking | ||
| 11.20am |
Legislative requirements for the pharmacovigilance system with focus on the Pharmacovigilance System Master File
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| 11.40am |
The new PSUR: key amendments following the EU pharmacovigilance legislation changes
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| 12pm |
Implementation of DSURs in Europe and with it the new developments placed on pharmacovigilance in the approval of new medicinal products
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| 12.20pm |
Keynote: Expectations of Health Authorities from the strengthening of the QPPV role
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| 12.40pm |
Transparency in the EU
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| 1pm | Lunch |
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