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SESSION 2: ENSURING GOOD CASE QUALITY
Session Chair(s)
Shelley Gandhi, MSc
Strategic Advisor, Pharmacovigilance and Drug Safety
NDA Group, United Kingdom
This session will describe how the QPPV can demonstrate oversight of the case management process from end to end, influence case quality, causality assessment and timeliness of expedited reporting including safety database validations and updates and consequences of any technical changes within this environment. The interface with product quality complaints will be examined as the QPPV would be expected to guide policies for medication errors, misuse and lack of effect.
Speaker(s)
ENSURING GOOD CASE QUALITY
Shelley Gandhi, MSc
NDA Group, United Kingdom
Strategic Advisor, Pharmacovigilance and Drug Safety
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