FDA: Food and Drug Administration.

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