Message from the Regulators: Pharmacovigilance to Move Heavily into Risk-Benefit Assessment
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Message from the Regulators: Pharmacovigilance to Move Heavily into Risk-Benefit Assessment
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Pilar Carrero Director of Safety Medical Writing at Novo Nordisk, joins Andrea Charles from Pharma IQ, to discuss the impact social media has had on drug safety and risk managment and the dawn of a new era for pharmacovigilance. Carrero also shares her insights on optimising pharmacovigilance activities and complying with the Development Safety Update Report (DSUR).
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Tags:
Pilar Carrero
Novo Nordisk
safety
regulatory reports
EU pharma package
risk-management
risk-management
document strategies
eCTD lifecycle management
IT systems
Development Safety Update Reports
DSUR
PSURs
safety medical writing
drug safety
Social Media
