By Julius K. Satsi, GNA
Accra, Aug. 31,
GNA - 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
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
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
the New Partnership for African Development and African Regulatory Harmonisation,
the School of Public Health at UG and the training facilitators.
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.
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.
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
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
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
urged the participant to find every means possible to stay in touch so as to
continuously share experiences and knowledge.
the training were from Nigeria, Zimbabwe, Uganda, Sierra Leone, Tanzania,
Liberia, Zambia, Gambia and Ghana.