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Pharmacovigilance Services in Egypt

Pharmacovigilance is vital when it comes to patient safety pertaining to medicinal products and medical devices and the importance of adverse drug reaction (ADR) reporting plays a central role to achieve this. In Egypt, the Egyptian Pharmaceutical Vigilance Center (EPVC) was established in the Egyptian Drug Authority (EDA) under the Ministry of Health and Population (MOHP) to be responsible for pharmacovigilance activities. ADRs can be reported through Yellow Card by anyone including healthcare professionals, nurses, pharmacists, caregivers, patient’s relatives, and patients/consumers, although EPVC prefers HCPs’ source of information. Marketing Authorization holders (MAH) should report the ADR by filling out the CIOMS form. It is mandatory for MAH to collect safety data and risks of their medicinal products and report them to EPVC for all serious events, while non-serious events can be reported in the Periodic Safety Update Report (PSUR). Also, as per the EPVC, dedicated QPPV should reside in the country for overseeing pharmacovigilance Solutions. Although Egypt has an advanced PV system in place, the lack of trained PV personnel to carry out the tasks and underreporting from the public are a few of the PV challenges experienced.

As a leading global contender, DDReg understand the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio for Egypt, we provide end-to-end Pharmacovigilance Services in Egypt that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR Processing & tracking sheets
  • Reconciliation process with customers
  • ", h32: "Risk Management Plan

  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)

Aggregate Reports

  • Periodic Benefit-Risk Evaluation Report (PBRERs)
  • Periodic Safety Update Report (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, Literature Monitoring, aggregate reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

QPPV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etcs.
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV and Deputy
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

PV Audit & Compliance

  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Conduct regular gap assessments of PV staff at site location.
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Provide organizational training on safety audits and inspections
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