The European Union, and the German Development Cooperation, through the German Development Cooperation (GIZ), in partnership with the Food and Drugs Authority (FDA) has organized a three (3) months hands-on assessor training program for some forty-one members of staff to boost its human resource capacity in readiness for effective regulation of vaccine manufacturing in Ghana that will meet international standards.
The training which was organized in three modules; Quality Assessors Training, Clinical Assessors Training and Non-Clinical Assessors Training, had officers selected from three departments namely- Vaccine and Biological Products, Clinical Trials, and the Safety Monitoring Departments of the FDA.
Speaking at the opening ceremony, the Chief Executive of FDA, Mrs. Delese Darko, reiterated the importance of the training in vaccine dossier evaluation and indicated that this formed a critical part of FDA’s response to the call by His Excellency, the President of the Republic of Ghana who pledged his unwavering commitment to transforming Ghana into a vaccine manufacturing hub for Africa. She added that “since then, the FDA with support from its partners have been diligently working at improving regulatory capacities to ensure the quality, safety and efficacy of locally manufactured vaccines.”
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She announced that “by November 2023, the FDA will take another pivotal step by initiating feasibility studies to construct an ISO Class 5 with 6 Background Cleanroom. FDA will also establish a Molecular Biology Laboratory and continue to acquire the necessary laboratory equipment to operationalize these facilities. These developments underscore our dedication to building the infrastructure to regulate locally manufactured vaccines”. In his remarks, the Team Lead of the GIZ support to Vaccine Manufacturing Component, Dr. Holger Till indicated that “together, we have made significant progress since the start of the project and very soon, FDA Ghana will have the full capacity in accordance with WHO standards for vaccine manufacturing regulation in Ghana”.
During the session, a couple of the participants shared insights on some of their impressions and expressed gratitude for the training. According to them, the hands-on assessors training to evaluate dossiers have given them an in-depth knowledge in the conduct of up-to-date protocols, within specified evaluation time and in accordance with legal and ethical requirements.
Prof. Kwabena Frimpong-Manso Opuni, a lecture at the University of Ghana, Legon and facilitator of the training, applauded the sponsors EU/GIZ for the Institutional and Technical strengthening support for the FDA staff to participate in the three-month program that had equipped them for the regulatory processes of vaccine production in Ghana.
Speaking on the mode of training, Prof. Opuni explained that the participants were grouped to review dossiers and solve preamble questions.Trainees were also tasked to evaluate sampled dossiers based on various indicators such as clinical trial, therapeutic aim, potential risks, compliance with manufacturing, import, and labelling requirements, amongst other documentation provided in the application dossier. He also informed the guests present that evaluating dossiers is one of the critical functions of the FDA and that approval is secured from the quality of decision-making practices and a satisfactory review.
The Hands-on Assessors training constitutes one of the key deliverables of the 2.84 million Euro Institutional and Technical Strengthening of Ghana’s FDA project intended to bridge capacity gaps to ensure quality, safety and efficacy of locally manufactured vaccines that meet international standards.
