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12 November 2019 | Story Leonie Bolleurs | Photo Leonie Bolleurs
Farmovs
At a first for South Africa, the SACRA clinical trials capacity-building workshop with government, research institutions, and industry, were from the left: Dr Nathaniel Mofolo, Dr Rita Nathan, Dr Mojalefa Maseloa (Head: Clinical Services in the Clinical Unit at the Universitas Hospital) and Sue Baily (Site Management Head at IQVIA).
Whether it is to treat the flu or a more serious illness, all medicines go through a very costly and lengthy research process before being approved for prescription to patients. The cumulative time from the beginning of trials to marketing approval has increased over the past ten years. 

According to Dr Vathi Papu-Zamxaka from the South African Clinical Research Association (SACRA), South Africans would not have had access to safe and effective medicines, had it not been for the intensive research conducted on new medicines. 

On 7 November 2019, a group of 115 delegates representing the Free State Department of Health, the UFS, private research sites, and the pharmaceutical industry met at FARMOVS on the Bloemfontein Campus of the University of the Free State (UFS) for the SACRA clinical trials capacity-building workshop.

2,1 billion dollars to develop one successful drug

Dr Michelle Middle, Chief Medical Officer at FARMOVS, provided some interesting stats on the process for drugs to hit the shelves: “One out of 10 drugs entering human research will be approved. The cost of development of one successful drug is approximately 2,1 billion dollars. And the time to develop a drug, from submission of the Investigational New Drug Application (IND) to approval by the Food and Drug Administration (FDA), is between 12 and 15 years.”

Dr Middle stated that drug development is one of the most regulated processes, with ethics and patient safety governing the undertaking. “With SAHPRA (South African Health Products Regulatory Agency) having some of the strictest regulations in the world, South Africa has a good history of running trials.  In addition, fast growth is expected for the pharmaceutical market on the African continent, necessitating the need for increased clinical trials on this continent,” she said. 

Very few clinical trials hosted in South Africa 

Although Africa has the broadest genetic variability of all human populations and carries 17% of the global population, very few clinical trials are hosted on the continent. Globally, there are currently approximately 322 000 clinical trials being actively conducted, of which only 1 700 are conducted in Africa, i.e. less than 3%.  Even worse, only 304 of the 1 700 trials running in Africa are conducted in South Africa.  There is thus a critical need for South Africa as a country to market itself as a clinical trial destination and to attract more trials to the country.

South Africa’s competitive edge lies in being known for its ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)-compliant top-quality research, racial and genetic diverse trial participants, good medical infrastructure and expertise, and the good reputation of the regulator (SAHPRA). “There are, however, a need for transformation and capacity building in clinical research in the country,” said Dr Middle. 

Dr Rita Nathan, Head of Clinical Services in the Clinical Department at the Universitas Hospital, who was representing government at the workshop, is looking to strengthen clinical trials across government and industry by focusing on, among others, funding models, operations management, and service delivery. 

From the UFS Faculty of Health Sciences, Dr Nathaniel Mofolo, Head of the School of Clinical Medicine, said collaboration between stakeholders is important. “This initiative is giving direction to the UFS vision of being a research-led university.” 

Other topics discussed at the workshop include the clinical trials landscape, how clinical trials work, the patient factor, ethics in clinical trials, and the economic aspect of clinical trials. 

News Archive

MBA Programme - Question And Answer Sheet - 27 May 2004
2004-05-27

1. WHAT MUST THE UNIVERSITY OF THE FREE STATE (UFS) DO TO GET FULL ACCREDITATION FOR THE MBA PROGRAMMES?

According to the Council on Higher Education’s (CHE) evaluation, the three MBA programmes of the UFS clearly and significantly contribute to students’ knowledge and skills, are relevant for the workplace, are appropriately resourced and have an appropriate internal and external programme environment. These programmes are the MBA General, the MBA in Health Care Management and the MBA in Entrepreneurship.

What the Council on Higher Education did find, was a few technical and administrative issues that need to be addressed.

This is why the three MBA programmes of the UFS received conditional accreditation – which in itself is a major achievement for the UFS’s School of Management, which was only four years old at the time of the evaluation.

The following breakdown gives one a sense of the mostly administrative nature of the conditions that have to be met before full accreditation is granted by the CHE:

a. A formal forum of stakeholders: The UFS is required to establish a more structured, inclusive process of review of its MBA programmes. This is an administrative formality already in process.

b. A work allocation model: According to the CHE this is required to regulate the workload of the teaching staff, particularly as student numbers grow, rather than via standard management processes as currently done.

c. Contractual agreements with part-time staff: The UFS is required to enter into formal agreements with part-time and contractual staff as all agreements are currently done on an informal and claim-basis. This is an administrative formality already in process.

d. A formal curriculum committee: According to the CHE, the School of Management had realised the need for a structure – other than the current Faculty Board - where all MBA lecturers can deliberate on the MBA programmes, and serve as a channel for faculty input, consultation and decision-making.

e. A system of external moderators: This need was already identified by the UFS and the system is to be implemented as early as July 2004.

f. A compulsory research component: The UFS is required to introduce a research component which will include the development of research skills for the business environment. The UFS management identified this need and has approved such a component - it is to take effect from January 2005. This is an insufficient element lacking in virtually all MBA programmes in South Africa.

g. Support programmes for learners having problems with numeracy: The UFS identified this as a need for academic support among some learners and has already developed such a programme which will be implemented from January 2005.

The majority of these conditions have been satisfied already and few remaining steps will take effect soon. It is for this reason that the UFS is confident that its three MBA programmes will soon receive full accreditation.

2. WHAT ACCREDITATION DOES THE UFS HAVE FOR ITS MBA PROGRAMME?

The UFS’s School of Management received conditional accreditation for its three MBA programmes.

Two levels of accreditation are awarded to tertiary institutions for their MBA programmes, namely full accreditation and conditional accreditation. When a programme does not comply with the minimum requirements regarding a small number of criteria, conditional accreditation is given. This can be rectified during the short or medium term.

3. IS THERE ANYTHING WRONG WITH THE ACADEMIC CORE OF THE UFS’s MBA PROGRAMMES?

No. The UFS is proud of its three MBA programmes’ reputation in the market and the positive feedback it receives from graduandi and their employers.

The MBA programmes of the UFS meet most of the minimum requirements of the evaluation process.

In particular, the key element of ‘teaching and learning’, which relates to the curriculum and content of the MBA programmes, is beyond question. In other words, the core of what is being taught in our MBA programmes is sound.

4. IS THE UFS’s MBA A WORTHWHILE QUALIFICATION?

Yes. Earlier this year, the School of Management – young as it is - was rated by employers as the best smaller business school in South Africa. This was based on a survey conducted by the Professional Management Review and reported in the Sunday Times Business Times, of 25 January 2004.

The UFS is committed to maintaining these high standards of quality, not only through compliance with the requirements of the CHE, but also through implementing its own quality assurance measures.

Another way in which we benchmark the quality of our MBA programmes is through the partnerships we have formed with institutions such as the DePaul University in Chicago and Kansas State University, both in the US, as well as the Robert Schuman University in France.

For this reason the UFS appreciates and supports the work of the CHE and welcomes its specific findings regarding the three MBA programmes.

It is understandable that the MBA review has caused some nervousness – not least among current MBA students throughout the country.

However, one principle that the UFS management is committed to is this: preparing all our students for a world of challenge and change. Without any doubt the MBA programme of the UFS is a solid preparation.

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