DDReg Pharma

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 activities. 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 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
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
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