Events & Courses

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate

Venue

  • Bawazir Pharma Office
    PJW5+79, Riyadh, 13513, Saudi Arabia
  • Phone
    +966500121286

Details

  • Start: 7 April، 2026 9:00 am - 4:00 pm
  • End: 8 April، 2026 9:00 am - 4:00 pm
Book Your Seat

Overview

Date of training 7-8 April 2026 Riyadh Saudi Arabia

FEES SAUDI RIYAL
REGISTRATION FEES SAR 6500.00
EARLY BIRDS REGISTRATION FEE

PAY YOUR FEE BEFORE 3 April 2026.

SAR 5200.00

OVERVIEW

Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.

 

Download Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_7-8 April_2026 Riyadh

Learning Objectives
  • Define the key principles and processes of pharmacovigilance
  • Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
  • Describe the component of the PV System
  • Understand the role and responsibilities of the QPPV
  • Understand national pharmacovigilance sub-system file (national PSSF)
  • Recognize SFDA oversight and processes during the post-approval phase.
  • Understand ADR case assessment, PSUR and risk management.
  • Interact appropriately with the SFDA regarding PV
  • Understand the process of PV inspection and audits.
  • Introduction to Pharmacoepidemiology and Pharmacovigilance
  • Pharmacovigilance systems and their quality systems
  • Pharmacovigilance System Master File
  • Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
  • Risk Management Systems
  • Management and Reporting of Adverse Reactions to Medicinal Products
  • Periodic Safety Update Reports
  • Post-Authorization Safety Studies
  • Signal Management
  • Safety Communication
  • Risk Minimization Measures
  • Pharmacovigilance Inspections
  • Pharmacovigilance Audits
  • Basic concepts of vaccines and adverse events following immunization

Professionals working in:

  • QPPV
  • Pharma Regulatory Affairs
  • Country Managers
  • Scientific Office Managers
  • Contract Research Organizations (CROs)
  • Regulatory Authorities.
  • Pharmacist
  • Compliance

What will you be able to do after the course?

  • Define the key principles and processes of pharmacovigilance
  • Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
  • Describe the component of the PV System
  • Understand the role and responsibilities of the QPPV
  • Understand national pharmacovigilance sub-system file (national PSSF)
  • Recognize SFDA oversight and processes during the post-approval phase.
  • Understand ADR case assessment, PSUR and risk management.
  • Interact appropriately with the SFDA regarding PV
  • Understand the process of PV inspection and audits.
Book Your Seat

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