Quote from VigiServe Admin on November 24, 2020, 3:16 PM Information is typically requested before the inspection, including: An up to date version of the Pharmacovigilance System Master File (PSMF). Organisation charts/lists of key personnel involved in pharmacovigilance activities. Written procedures and processes relating to the pharmacovigilance system. Line listings of adverse events. List of any organised data collection systems. Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). Lists of safety signals identified by the MAH and associated key dates of processing. Lists of safety variations submitted/due for submission by the MAH. Current copies of approved reference safety information (e.g. Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs)).
Information is typically requested before the inspection, including:
An up to date version of the Pharmacovigilance System Master File (PSMF).
Organisation charts/lists of key personnel involved in pharmacovigilance activities.
Written procedures and processes relating to the pharmacovigilance system.
Line listings of adverse events.
List of any organised data collection systems.
Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
Lists of safety signals identified by the MAH and associated key dates of processing.
Lists of safety variations submitted/due for submission by the MAH.
Current copies of approved reference safety information (e.g. Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs)).
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Information is typically requested before the inspection, including:
An up to date version of the Pharmacovigilance System Master File (PSMF).
Organisation charts/lists of key personnel involved in pharmacovigilance activities.
Written procedures and processes relating to the pharmacovigilance system.
Line listings of adverse events.
List of any organised data collection systems.
Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
Lists of safety signals identified by the MAH and associated key dates of processing.
Lists of safety variations submitted/due for submission by the MAH.
Current copies of approved reference safety information (e.g. Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs)).