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SFDA Pharmacovigilance System Explained 26-27 February, 2023 Riyadh, Saudi Arabia

Venue

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

Details

Start:
26 February، 2023 @ 9:00 am
End:
27 February، 2023 @ 4:30 pm

Organizer

Bawazir Pharma Consulting
Phone:
+966500121286
Email:
info@bawazirpharma.com

Note:  All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES SAUDI RIYAL
REGISTRATION FEES SAR 5000.00
EARLY BIRDS REGISTRATION FEE

PAY YOUR FEE BEFORE 19 February, 2023.

SAR 3500.00

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 SFDA Pharmacovigilance System Explained 26-27 February 2023 Riyadh, 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