Note:  This training require physical presence and will be held in Jeddah

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 SFDA Pharmacovigilance System Explained 6-7_February 2023 Jeddah, Saudi Arabia

LEARNING OBJECTIVES

At the conclusion of this training, participants will be able to:

• 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.

KEY TOPICS

• 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

WHO WILL ATTEND

Professionals working in:

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