Objectives.

Training chosed persons to be qualified for Pharmacovigilance (QPPV).
Who should attend.

P.V. Department.
Medical affair.
Regulatory affair.
Contents of the course.

Definitions.
ICSR
Why Pharmacovigilance?
P.V. SOPs.
Pharmacovigilance GVP book for arab guidelines (EPVC).
PSMF
PSUR
RMP
Achievement .

Understand objectives of P.V.
Follow up of EPVC instructions
Training subordinates.
Writing P.V reports and SOPs(PSMF).
Pharmacovigilance certification.
Duration .

3 days (21 hours)