The New Saudi Arabian Pharmacovigilance Guidelines of June 2015, Dubai

Topics

• Quality Management Systems
• An Introduction to the new PV Structure
• Pharmacovigilance Inspections (Module III)
• He Pharmacovigilance Systems Master File (PSMF – Module II)
• Risk Management Plans (RMPs – Module V)
• Pharmacovigilance Audits (Module IV) – A break for afternoon tea will occur within this talk
• MODULE VI – Adverse reaction Reporting – Part 2
• MODULE VI – Adverse reaction Reporting – Part 1
• Signals and their Management (Module IX)

Who should Attend

• Anyone involved in Pharmacovigilance and Regulatory activities, including pharmacovigilance case processing; Local QP PVs; Medical Directors; Drug Safety Managers; QA auditing; PSUR writers