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Pharmacovigilance Vendors and Audit Readiness
Common questions asked by the Pharmacovigilance Inspector, with regards to Pharmacovigilance vendors Are all the Pharmacovigilance activities handled in-house? Have you outsourced any of your Pharmacovigilance activities? On what basis was the vendor selected? Qualification process? Audit? Onboarding process? Does the vendor have any BCP measures in place? Can you show the details of this […]
How can Pharmacovigilance Help?
The primary objective of Pharmacovigilance is to ensure that safe and effective medicines are available for Public Health. In August 2020, the FDA removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin, based on the review of new data from three clinical trials. This boxed warning was imposed in May 2017. Thanks […]