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This document discusses pharmacovigilance inspections. It defines pharmacovigilance inspection as the systematic examination of pharmacovigilance activities and documents to determine if they were properly conducted and reported. The goal of pharmacovigilance is to protect public health by improving patient safety related to medicine use. Inspections aim to confirm marketing authorization holders are meeting pharmacovigilance obligations and identify any non-compliance risks. In Saudi Arabia, inspections are conducted by the Pharmacovigilance Inspection department within the National Pharmacovigilance and Drug Safety Centre. Inspections generally involve planning, conducting document reviews and facility tours, and closing meetings to discuss findings.
This document discusses pharmacovigilance inspections. It defines pharmacovigilance inspection as the systematic examination of pharmacovigilance activities and documents to determine if they were properly conducted and reported. The goal of pharmacovigilance is to protect public health by improving patient safety related to medicine use. Inspections aim to confirm marketing authorization holders are meeting pharmacovigilance obligations and identify any non-compliance risks. In Saudi Arabia, inspections are conducted by the Pharmacovigilance Inspection department within the National Pharmacovigilance and Drug Safety Centre. Inspections generally involve planning, conducting document reviews and facility tours, and closing meetings to discuss findings.
This document discusses pharmacovigilance inspections. It defines pharmacovigilance inspection as the systematic examination of pharmacovigilance activities and documents to determine if they were properly conducted and reported. The goal of pharmacovigilance is to protect public health by improving patient safety related to medicine use. Inspections aim to confirm marketing authorization holders are meeting pharmacovigilance obligations and identify any non-compliance risks. In Saudi Arabia, inspections are conducted by the Pharmacovigilance Inspection department within the National Pharmacovigilance and Drug Safety Centre. Inspections generally involve planning, conducting document reviews and facility tours, and closing meetings to discuss findings.
DEA : Drug Enforcement Administration. DEA Is responsible for the regulation of
controlled substances (substances with abuse and addiction potential) in the US.
PSURs SUSAR SFDA : Saudi Food And Drug Authority. CIOMS E2B ICH ADRs Med DRA GPvP
Pharmacovigilance inspection is defined by Dr. Cobert as A systematic and independent examination of activities and documents
Related to suspected adverse drug reaction reports
To determine whether the evaluated activities were conducted and the data were recorded, analyzed, and accurately reported according to relevant manuals, standard operating procedures (SOPs), good Pharmacovigilence practice, and regulatory requirements . Goal of Pharmacovigilance Protecting the public health by improving patient safety in relation to the use of medicines Objectives Determine that the marketing authorization holder has personnel, systems and facilities in place to meet their Pharmacovigilance obligations Identify, record and address non compliance which may pose a risk to public health; Use the inspection results as a basis for enforcement action where considered necessary How can we achieve that ? Confirming that Pharmacovigilance guidelines are committed by Marketing Authorization holder (MAH) Monitoring the Pharmacovigilance system of MAH through doing routine inspection and targeted Inspections Pharmacovigilance inspection at the SFDA Pharmacovigilance inspection is A department division within the National Pharmacovigilance and Drug Safety Centre (NPC) at the Vigilance and Crisis Management Executive Directorate (VICM) Pharmacovigilance system According to Saudi Pharmacovigilance guideline the Applicant for a marketing authorization is required to provide a detailed description of the system of Pharmacovigilance Pharmacovigilance System Master File (PSMF) Summary of Pharmacovigilance System (SPS) SPS is a document that summarizes drug safety functions of the company Summary of Pharmacovigilance System (SPS) Section 1: Contains information details about Pharmacovigilance staff and QPPV and the locations of Pharmacovigilance activities. Section 2: Contains information about structure of the company and the model operating of pharmacovigilance Section 3: Contains information about Pharmacovigilance activities in Saudi Arabia and global pharmacovigilance department of the company. Section 4: Contains information details about computerized systems of pharmacovigilance department in the company. Section 5: Contains information about Quality Management System. Section 6: Contains information about Training Records ( such as CVs and job descriptions for who involved in pharmacovigilance activities and location of records) Section 7: Contains information about Archiving. Notification of Inspection Announced Majority Send a letter or email Make the staff available Unannounced Not always Knock the door Short time communication Urgent safety reason : Inspection preparation
Inspection preparation: Interactions between assessors and inspectors Plann ing Coordinate Conduct Report Follow up Regulatory body starts prepare using several tasks Communications with the MAH (announced) Request documents (SPS) Communications internally Well planning Conduct: Opening meeting with the MAH Introduction Plan of the inspection Company could give small background Inspection process Document review Tour to visit all places related to PV Close meeting Findings