Pharmacovigilance Software in Egypt
InFlow-PV runs case intake, case processing and periodic safety reporting for the QPPVs and drug-safety officers inside Egyptian marketing authorization holders, with Arabic-speaking local support behind it.
What an Egyptian MAH's Pharmacovigilance Operation Has to Run
A marketing authorization holder (MAH) operating in Egypt runs pharmacovigilance the same way an MAH anywhere does: a Qualified Person for Pharmacovigilance (QPPV), or a locally appointed safety officer acting under that function, owns a system that can detect, collect, assess and report adverse events for every product on the market. That system cannot wait for reports to arrive through one tidy channel — it has to pick up a report whether it comes from a medical representative in the field, a call centre agent, a hospital pharmacist, a routine literature search, or a partner company forwarding a case from another market.
Day to day, that means running several things at once: intake from every source, case processing that turns a raw report into a complete and coded case, individual case safety reports (ICSRs) once a case is valid and serious enough to be expedited, and periodic aggregate reporting that rolls every case for a product into a single safety review. Behind all of it sits a document most inspectors ask for by name: the Pharmacovigilance System Master File (PSMF), which describes the QPPV, the procedures and the system well enough that an inspector unfamiliar with the company can follow how a report becomes a filed case. InFlow-PV is CORPEX's pharmacovigilance software for that operation — one system where intake, case processing, quality control, medical review and reporting live together with an audit trail on every step, rather than a spreadsheet stitched to a shared inbox.
The Regulatory Requirement Behind Every Case
Two internationally recognized frameworks set the shape of case processing everywhere, including Egypt. ICH E2D defines the four minimum criteria for a valid individual case safety report — an identifiable patient, an identifiable reporter, a suspect drug and a suspect adverse event — and the expedited reporting clock that starts once those four are met. Under ICH E2D and the EU's GVP Module VI, a serious, unexpected adverse reaction is typically expected to reach an authority within 15 calendar days of the company first becoming aware of it, with fatal or life-threatening cases handled on a shorter clock still. These are the general international benchmarks a PV system is built around; the exact filing windows a given national authority applies are set out in that authority's own guidance.
Periodic aggregate reporting runs on a different clock. A Periodic Safety Update Report (PSUR), or a Periodic Benefit-Risk Evaluation Report (PBRER) in the ICH E2C(R2) format most regulators now expect, rolls up everything observed for a product since the last report — not because any single case demands it, but because a genuine safety signal is usually visible only in the aggregate. The PSMF is what ties the two together: the single reference an inspector reads to understand how intake, case processing and periodic reporting actually operate inside a company, rather than how a procedure says they should.
How InFlow-PV Runs a Case From Intake to Report
InFlow-PV carries an adverse event report from first contact through to a closed, reportable case, with each stage documented and attributable to the person who performed it.
1. Case Reception
Every report is logged centrally regardless of where it came from — a sales rep, a call centre, a literature screen, a partner company — with the date it was first received recorded precisely, because that date starts the reporting clock.
2. Case Validation
Each report is checked against the four minimum criteria for a valid case. A report missing any of the four is tracked as incomplete pending follow-up instead of being set aside.
3. Safety Data Entry
Valid cases are entered into InFlow-PV in structured form, so the same case does not have to be re-keyed at every later stage of processing.
4. Quality Control
A second reviewer checks the entered case against the source document before it goes to medical review — the same second-check principle used in a GMP QC laboratory.
5. Medical Review
A PV physician assesses seriousness and causality, and that judgment becomes part of the permanent case record before the case moves further.
6. Reporting
InFlow-PV produces the individual case safety report for a reportable case, and feeds the same case data into the next periodic aggregate report.
What an Inspector Looks For in a Pharmacovigilance System
A PV inspection is less about any single case and more about whether the system behind it is consistent, timely and traceable. The records InFlow-PV keeps are built to answer these questions directly:
- Timeliness: was the reporting clock started on the date the company first had minimum information, and was the report filed inside the expected window.
- Follow-up: does an incomplete case show a documented attempt to close the gap rather than sitting unresolved.
- Consistency: is causality and seriousness assessed the same way across reviewers and cases.
- Traceability: who validated the case, who performed medical review, who approved dispatch — each step timestamped and unchangeable once signed.
Where InFlow-PV Connects to the Rest of the Quality System
Not every adverse event walks in the door labeled as one — many start as a customer or physician complaint. Connecting InFlow-PV's intake to CORPEX complaints management means a report raised through that channel does not get missed or handled twice.
Because a safety case is itself a controlled quality record, InFlow-PV shares its audit-trail and electronic-signature model with the rest of CORPEX eQMS software in Egypt, so drug-safety governance sits inside the same reviewed system as document control and CAPA rather than a separate island of data.
Implementation and Validation
A pharmacovigilance system is a GxP computerized system, which means deploying it is itself subject to validation before it can be relied on for regulatory reporting. CORPEX runs computer system validation (CSV) services in Egypt alongside implementation — a validation master plan, IQ/OQ/PQ testing, and the documentation package an inspector will ask to see — so InFlow-PV is inspection-ready at go-live rather than validated after the fact.
Pharmacovigilance Software Built for Egyptian Teams
The Egyptian Drug Authority (EDA) operates a national Pharmacovigilance Center that Egyptian marketing authorization holders report adverse drug reactions to, as part of Egypt's participation in the WHO Programme for International Drug Monitoring. CORPEX Informatics is an Egyptian company headquartered in the New Administrative Capital, and builds InFlow-PV with that local reporting context, Arabic-language support and an Egypt-based implementation and support team in mind, alongside the eQMS software CORPEX already delivers to Egyptian pharma and manufacturing companies.
Pharmacovigilance System Requirements
For a closer look at what a PV system needs to hold up under inspection, see CORPEX's guide to pharmacovigilance system essentials.
Ensure Drug Safety in Your Egyptian Operation
Talk to CORPEX about deploying InFlow-PV — in Arabic or English.
Contact UsPharmacovigilance Software in Egypt — Frequently Asked Questions
What is pharmacovigilance software, and who uses it at an Egyptian pharmaceutical company?
Pharmacovigilance software is the system that takes in adverse event reports, moves them through case processing and medical review, and produces the case and periodic safety reports a marketing authorization holder must keep on file. At an Egyptian pharma company it is run day to day by the QPPV or a locally appointed drug-safety officer, with a PV physician doing medical review and QA staff signing off before a case or report goes out.
What is an ICSR, and when does a case become reportable?
An Individual Case Safety Report (ICSR) is the structured report of a single adverse event. Under ICH E2D, it becomes reportable once four minimum criteria are met: an identifiable patient, an identifiable reporter, a suspect drug and a suspect adverse event. From that point, expedited reporting timelines apply, which is why InFlow-PV records the date a case was first received precisely.
What is a PSMF and why does an inspector ask for it?
The Pharmacovigilance System Master File (PSMF) is the document, described in ICH and EU GVP guidance, that lays out the QPPV, the procedures and the system architecture behind a company's drug-safety operation. An inspector unfamiliar with a company reads the PSMF first to understand how a report is meant to move from intake to a filed case, then checks the records to see whether that is what actually happens.
What is the difference between a PSUR and a PBRER?
Both are periodic aggregate safety reports covering everything observed for a product over a defined period rather than a single case. PBRER (Periodic Benefit-Risk Evaluation Report) is the ICH E2C(R2) format most regulators now expect; PSUR is the term still used in some markets and legacy filings. InFlow-PV generates both from the same underlying case data.
How does pharmacovigilance reporting work in Egypt?
The Egyptian Drug Authority (EDA) operates a national Pharmacovigilance Center that Egyptian marketing authorization holders report adverse drug reactions to, as part of Egypt's participation in the WHO Programme for International Drug Monitoring. CORPEX is an Egyptian company and builds InFlow-PV with that local reporting context and Arabic-language support in mind.
Does InFlow-PV support Arabic and local implementation in Egypt?
Yes. InFlow-PV is delivered with Arabic-language support and an Egypt-based implementation and support team, the same local footprint CORPEX already brings to the eQMS software it delivers to Egyptian pharmaceutical and manufacturing companies.