Partnering for Success in Egypt Pharmacovigilance
If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Egypt, explore DDReg’s pharmacovigilance services in Egypt is to ensure drug safety and pharmacovigilance in Egypt as well as regulatory compliance. From adverse drug reaction reporting to alignment with Egyptian pharmacovigilance guidelines, the right PV partner shapes signal detection, risk management planning, safety reporting, and successful market authorization.
Expert Pharmacovigilance Services for the Egypt Market
The Egyptian Pharmacovigilance Center (EPVC), established under the Egyptian Drug Authority (EDA) of the Ministry of Health and Population, is the national authority responsible for pharmacovigilance activities, including ADR reporting systems like the Yellow Card and CIOMS forms. These Egyptian pharmacovigilance guidelines stem from ministerial decree 368/2012 and align closely with European GVP practices, while allowing for country-specific adaptations.
Healthcare professionals, patients, pharmacists, and caregivers can report ADRs, though EPVC prefers reports from HCPs. Serious events must be reported via CIOMS, while non-serious events are included in Periodic Safety Update Reports (PSURs). To ensure local oversight, a Qualified Person for Pharmacovigilance (QPPV) must reside in Egypt and take responsibility for the PV system. Despite an advanced system, challenges persist, such as underreporting and a shortage of trained staff.
Why Choose DDReg as Your Pharmacovigilance Consultant in Egypt?
As a leading global PV services provider , DDReg understands the importance of pharmacovigilance consulting services from clinical trials through post-marketing surveillance. Our comprehensive pharmacovigilance service providers in Egypt offer tailored solutions that ensure compliance with local requirements and good pharmacovigilance practices.
Our Pharmacovigilance & Drug Safety Services in Egypt Include:
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ICSR Processing & Submission
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Risk Management Plan (RMP)
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Aggregate Reports
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Signal Management
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QPPV Services
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PV Quality Management & Compliance
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Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
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Risk Management
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Audit and Compliance
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Pharmacovigilance Signal Management Services
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QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
