Spring Intro 2023

16/02/2023

GVP Inspections

Key Regulatory input required: ● Maintenance of tracking systems for distribution of: – RMMs e.g. Educational tools – DHPCs ● Dates when variations were submitted/approved/implemented in packs ● Compliance and communication related to Core Datasheet ● Provide key documents e.g. latest PSURs/RMPs/EU PI • May be routine, “for cause”, systems or product related ● For cause – investigate a specific issue ● Systems: procedures, systems, personnel, and facilities ● Product-related

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PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF)

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