Events
Closure of WHO Intensive Training Course on Marketing Authorization Procedures for Pharmaceutical Products
The Egyptian Drug Authority has announced the closure of an intensive training course, scheduled to continue for five consecutive days from April 21st to April 25th, 2024. This course was organized by the Continuous Professional Development Center of the Egyptian Drug Authority in collaboration with the World Health Organization - Egypt Office.
The day's events were attended by Dr. Hanan Amin, Head of the Central Administration for Pharmaceutical Products, and Dr. Hamada Sharif, Deputy Head of the Authority. From the World Health Organization, Dr. Mona Marouf, Coordinator of Pharmaceutical Affairs, and Dr. Louis Goffia, Advisor, both from the Egypt Office, were present.
The aim of the training course is to provide a dedicated training opportunity for employees of the Central Administration for Pharmaceutical Products at the Egyptian Drug Authority and to exchange experiences in market surveillance to comply with the latest international standards and implement globally recognized regulatory procedures according to WHO Good Practices for Pharmaceutical Quality Control. This is within the framework of the Egyptian Drug Authority's efforts to support and develop the capacities of its workforce, leading to the enhancement of their technical capabilities, which in turn contributes to the development of the national industry and strengthens the capacity of the local market to keep pace with international changes.
Key topics discussed include: the submission process for locally manufactured pharmaceutical product files, exchanging experiences, and discussions between the authority's employees and Dr. Louis Goffia, a consultant from the World Health Organization - Egypt Office, regarding local and international mechanisms for issuing marketing authorizations for pharmaceutical products to ensure safe and effective drugs for patients' safety. This is in line with the efforts of the Egyptian Drug Authority, one of the most important pharmaceutical regulatory bodies in the Middle East, towards implementing the principles and foundations of pharmaceutical product accreditation within the Arab Republic of Egypt based on the principles adopted by health authorities in the reference countries. This includes evaluating variations after registration and bioequivalence studies, as well as selecting reference products and different types of studies relied upon in evaluating the product file.
The trainees, numbering 26, are employees of the Central Administration for Pharmaceutical Products at the Egyptian Drug Authority.
This is part of the Egyptian Drug Authority's plan aimed at enhancing the professional level of all its employees, keeping them informed of all developments in all fields, contributing to building effective human resources capable of achieving institutional development and excellence, in line with the strategic goals of sustainable development and Egypt's vision 2030."
Tags
WHO
The Egyptian Drug Authority (EDA)