Events
Completion of the training program on Pharmaceutical Vigilance system Master File and inspection .
The Egyptian Drug Authority has announced the completion of a training program on Pharmaceutical Vigilance system Master File and inspection for pharmaceutical companies (from the basic level to the advanced level).
During the training program, each Qualified person of pharmacovigilance (QPPV) was trained and empowered to fully understand the Pharmaceutical Vigilance system Master File and the rules for their assessment in a practical manner. The mechanisms for completing the files submitted to the Egyptian Drug Authority, represented by the General Administration of Pharmaceutical Vigilance (PVGA), and the criteria for each file to be accepted by the administration , as well as a detailed explanation of the inspection process of pharmacovigilance department of drug companies and how companies prepare for inspection requirements and fulfill them, the inspection report, and the implementation of resulting corrective measures by the company.
This is part of the effort to increase skills and keep pace with the continuous development of the drug industry worldwide and locally, and to increase the level of work to the highest possible level in the field of pharmaceutical vigilance by ensuring that the principles of good pharmaceutical vigilance are applied, which by extension reflect the safety and effectiveness of the drug and its most effective and safe access to the patient.
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The Egyptian Drug Authority (EDA)
the training program on Pharmaceutical Vigilance system Master File and inspection