​There was much to celebrate when the division of Clinical Pharmacology's academic Medicine Development Programme was recently re-awarded certification by the PharmaTrain Centre of Excellence. Certification by the centre is one of the highest achievements an institution can reach in international medicine development.

Prof Helmuth Reuter, head of the Division of Clinical Pharmacology, described the re-certification of the division, following a rigorous assessment process, as a great honour.

“I am delighted that our Division's Medicine Development Programme has been re-awarded this certification," Reuter said, adding that the Stellenbosch University programme is the only centre in Africa that has been recognized by PharmaTrain and the only centre of excellence outside of Europe.

“Currently, we draw students from across Africa. This re-certification gives us a status, so if we work on this, we will be able to attract students from outside of Africa as well.

“We have lecturers from outside Africa, but would be potentially interested to offer this course to people from outside Africa," said Reuter.

Explaining the importance of responsible medicine development, Reuter said: “Drugs are a wonderful human invention, often based on plants, natural products or chemicals. In the new era of biologic medicines, it is, of course, important to ensure that the molecules and structures comprising the drugs are safe and effective in combating or preventing disease. For this to happen, they need to go to a development process, Medicines development includes testing the drugs to establish their efficacy and to ensure they are safe and non-toxic, as well as taking the medicines through a process of regulations. Once the entire dossier of information has been assessed, a decision is made as to whether it can be registered as a medicine that can be brought to the market."

“The PharmaTrain assessors concluded that the current Postgraduate Diploma in Medicines Development (PG Dip Medicines Development) course together with the Masters (MPhil) in Medicines Development (MMD) programme (in preparation, to start in 2020)  offered by the Division of Clinical Pharmacology fulfil the PharmaTrain standards and quality requirements for a centre of excellence certification," Reuter said.

The certification initiative started off as a project of the Innovative Medicines Initiative (IMI) in Europe with the aim of removing bottlenecks in the development of drugs. The initiative became the the PharmaTrain Federation in 2014 to continue its mission beyond the frames of a publicly funded European project.

The project has formulated guidelines and standards for the development of postgraduate courses in medicine development and related fields. It has also put together criteria and processes to harmonise and evaluate the universities which offer these courses, all with a view to raising the quality of education in the field.

Reuter said students in the division would benefit greatly from the certification. “It gives internationally respected recognition in medicine development/pharmaceutical medicine circles. This may attract more postgraduate students because they will get an internationally acclaimed diploma."

“All Courses that go through a PharmaTrain course recognition process are awarded the PharmaTrain Course Recognition if they cover at least one PharmaTrain Syllabus Topic and fulfil the PharmaTrain Quality Criteria," he said.

Reuter said the certification of his division means that candidates on the course are given skills in all the areas of medicines development. “Most of the people studying this course will work in the pharmaceutical or health industry – and they will be trained to do their work with excellence," he said.

“The pharmaceutical industry is huge – so it is important for those working in the industry to be familiar with the processes so that in the end, medicines can be produced more efficiently and safely and regulation and registration can take place in good time."