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SESSION 1: DEFINING THE SCOPE OF SYSTEM AND RELATIONSHIPS: GETTING ORGANISED
Session Chair(s)
Shelley Gandhi, MSc
Strategic Advisor, Pharmacovigilance and Drug Safety
NDA Group, United Kingdom
This session covers systems accountability, how relationships with the MAH and the wider company should be set-up and documented. This includes techniques such as delegation, deputisation and good practices for personal job descriptions, training and contracts. The QPPV is expected to maintain regulatory confidence in the quality of the PSMF.
Speaker(s)
DEFINING THE SCOPE OF SYSTEM AND RELATIONSHIPS: GETTING ORGANISED
Shelley Gandhi, MSc
NDA Group, United Kingdom
Strategic Advisor, Pharmacovigilance and Drug Safety
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