The New Saudi Arabian Pharmacovigilance Guidelines of June 2015, Dubai covers topics such as:
- 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)
The New Saudi Arabian Pharmacovigilance Guidelines of June 2015, Dubai brings together:
- Anyone involved in Pharmacovigilance and Regulatory activities, including pharmacovigilance case processing; Local QP PVs; Medical Directors; Drug Safety Managers; QA auditing; PSUR writers