Third RCORE fellowship training ends in Accra

Accra- The Food and Drugs Authority (FDA), the only designated Regional Centre of Regulatory Excellence (RCORE) on Friday ended its third clinical trials fellowship training aimed at improving access to medicine by harmonizing regulatory requirements.

The four weeks training sought to build capacity in clinical trials within the sub-region to enhance the conduct of clinical trials and help in ensuring that African citizens have access to quality, safe and efficacious medication, medical devices and health products.

In her address at the closing ceremony in Accra, Mrs Delesse Darko, the Chief Executive Officer of the FDA, said the fellowship training is a collaboration between the Authority and the School of Public Health of the University of Ghana (UG).

She said the training provided a platform for regulators, researchers and clinical trials stakeholders to meet and continuously share ideas and experiences to enhance the conduct of clinical trials.

She said the training covered topics such as: Clinical Trails Authorisation; Good Clinical Practice inspections; Adverse Events and Safety Monitoring.

Mrs Darko said the 13 participants from nine African countries benefitted from practical regulatory attachment, allowed to inspect an active trial, been part of the 57th TACT meeting.

She said the participants were also made to evaluate a clinical trials protocol using the newly adopted African Vaccine Regulatory Forum (AVAREF) guidelines and forms.

She commended the New Partnership for African Development and African Regulatory Harmonisation, the School of Public Health at UG and the training facilitators.

Mrs Delesse said she was optimistic that the training would go a long way to improve the conduct and regulation of Clinical Trials not only in participants’ various countries but across the African continent.

Professor Julius Fobil, the Dean of the School of Public Health at the UG, said the School was of the conviction that there was nothing reassuring than to believe that what practitioners do on daily basis was the right thing.

He said ensuring that what one regulator was the right meant that exactly what was being done in one country was exactly the same processes being carried out by neighbouring countries.

He said usually regulators were not sure of the strategies being used whether or not they were the best available, which had been a major setback in the African region over the years.

Prof Fobil said having gone through the training and sharing the various experiences from the different countries will culminate into a stronger force in sub-region towards the conduct of clinical trials.

He said: I am more than confident that you are going improve your performance on the job otherwise the training will be meaningless.

He said there was no differences between the African countries and hence putting efforts together on a regular basis, would lead to creating a stronger regional coalition.

Prof Fobil urged the participant to find every means possible to stay in touch so as to continuously share experiences and knowledge.

Participants of the training were from Nigeria, Zimbabwe, Uganda, Sierra Leone, Tanzania, Liberia, Zambia, Gambia and Ghana.

Source: Ghana News Agency