Programs

Pharmacovigilance Training Proposal

What does Pharmacovigilance Mean?

Pharmacovigilance (PV) is defined by European Commission (EU) as the "Process and Science of Monitoring the Safety of Medicines  and taking action to reduce the risks and increase the benefits of medicines".

What is the main aim of Pharmacovigilance?

The aim of PV Systems is to Monitor the risk/benefit ratio of drugs as well as improve patients' safety and their quality of life.

Pharmacovigilance Training Program

-The Workshop Consists of seven waves, each wave consists of three lectures (each lecture is about 3 hours).

-The full Training course is about 60 hours.

-The wave consists of theoretical background and practical hands-on training workshop.

-Reference is "The Good Pharmacovigilance Practice for Arab Countries" and https://www.ema.europa.eu/

The workshop Covers the following topics:

Wave 1  -Introduction to pharmacovigilance.

-Establishment of Pharmacovigilance System.

-Pharmacovigilance System master life.

Wave 2  -ICSRs Management.

-Case Narrative Writing for ICSRs.

-Reporting of Medication errors in Pharmacovigilance.

Wave 3  -Risk Minimization Plan.

Wave 4  -Signal Management.

-Additional Monitoring.

-Safety Communication.

Wave 5  -Periodic benefit-risk evaluation report.

Wave 6  -Addendum of Clinical overview.

-Post Authorization Safety Studies.

Wave 7  -Vaccinovigilance.

-PV quality System & Audit.