QPPV & Pharmacovigilance Training
Pharmacovigilance training built around what EDA actually inspects — delivered by the team that manages PV for 35+ pharma companies in Egypt and Iraq.
Training from practitioners, not academics.
Most regulatory training in Egypt is delivered by academic professionals who teach the guidelines as written. EMCO Egypt's QPPV training is delivered by operational practitioners who teach the guidelines as practised — in Egypt, under EDA, within the specific context of how Egyptian and MENA pharma companies actually work.
When our QPPV trainer explains what EDA inspectors look for in a PSMF, it is because they have managed PSMFs through actual EDA inspections. When they explain the 15-day expedited reporting window, they process real ICSRs against that deadline every week.
Training is available in Arabic and English, in-person and online, and as corporate on-site programmes.
Who this training is designed for
Pharmacists & Regulatory Affairs
Pharmacists and regulatory affairs professionals who are, or will become, the named QPPV at their organisation. Provides the qualification foundation and operational knowledge for the role.
Regulatory Affairs Teams
Teams building or improving a pharmacovigilance system for the first time. Medical affairs and drug safety teams in Egyptian pharmaceutical companies or multinational distributors operating in Egypt.
Inspection Preparation
Companies preparing for an EDA pharmacovigilance inspection. The training covers what inspectors examine, what documentation they request on day one, and how to prepare your team for inspection interviews.
What the training covers
- Egyptian GVP requirements and PVGA pharmacovigilance guidelines
- The QPPV role — legal responsibilities, operational duties, and what EDA expects
- PSMF structure, mandatory content, maintenance, and common inspection findings
- ICSR management — intake, triage, narrative writing, and 15-day expedited window compliance
- Literature monitoring under GVP Module VI — what is required and how to document it
- Signal detection — methods, documentation, and escalation process
- PSUR/PBRER preparation and EDA submission requirements
- EDA inspection readiness — what inspectors examine, common findings, and CAPA management
- Hands-on PV Radar demonstration — the software used in EMCO's live PV operations
Format: 3 days | In-person, online, or corporate on-site | Arabic and English
The next EDA inspection will test your PV system. This training prepares the people who run it.
Individual and group enrolment open year-round. Corporate on-site programmes available with minimum two weeks' lead time.
Enquire About Training PV Outsourcing