The two-year Post-graduate Diploma in Applied Chemistry started at the University of Malta's Faculty of Science in February 2006, with the primary objective of satisfying the postgraduate education needs of the growing local pharmaceutical industry with those of the other organisations involved in drug distribution or regulation.

The course was, from the start, designed to provide students with an overview of how the modern pharmaceutical industry operates - with special emphasis on the applied scientific principles and methodology involved in pharma research and development, manufacturing technology, quality assurance and regulatory affairs.

It was intended that at the end of the course, students would be highly qualified to join, or continue to further their careers in, the pharmaceutical industry or the Malta Medicines Authority. It was also expected that the extent of knowledge gained would allow them to successfully tackle complex scientific, regulatory and decision-making challenges in their work environment, to participate more actively in teamwork within the workplace and in international fora, while ensuring their eligibility for QP registration. The latter area - which uniquely qualifies a graduate to personally release pharmaceutical products on the EU market - is one where a skills shortage has been identified.

The course has had tremendous support from several Maltese organisations directly or indirectly associated with the pharmaceutical industry, including the Malta Federation of Industry (FOI), Malta Enterprise, Arrow Pharm (Malta), Actavis Ltd, the Malta Qualified Persons Association, the Department of Chemistry at the Faculty of Science and the Malta Medicines Authority. The Ministry of Education - through the University - played a major role by providing the initial financial support to ensure that lecturing costs were fully covered and to contribute towards acquiring necessary laboratory equipment.

Now that the Post-Graduate Diploma has started its second year, it would be interesting to analyse the progress registered to date and the extent to which the initial objectives have been reached.

The scientific content and value of the course has been outstanding, and the curriculum has been compared very favourably to (and in some cases is superior to) several similar courses being organised in Europe.

Lectures are being led by either local or foreign lecturers who have considerable hands-on experience and theoretical grounding in the pharmaceutical industry as well as in academia. First-hand interaction of the students with these individuals has given them the opportunity to ask penetrating questions, to open interesting discussions about theoretical or practical issues and to increase their confidence in their day-to-day duties.

Working students have begun to comprehend and appreciate more fully the importance of their role within the respective organisations. Feedback, especially from the local pharmaceutical industry, has also been very positive. In fact, it has been remarked by managers from the companies sponsoring students that the course participants have all shown a significant and positive change in their self-confidence as well as in the quality of their output at the workplace.

To ensure that students are given the best analytical instrumentation training possible, financial backing has been secured for the establishment of a state-of-the-art analytical laboratory, at par with anything that can be found elsewhere in Europe.

This is currently being equipped with modern instrumentation, essential for the analysis of drug substances in both biological and formulation matrices, and for the identification of trace levels of impurities or degradation products. Facilities will include separation equipment, in particular, gas chromatography (GC) and high-performance liquid chromatography (HPLC) together with a range of spectroscopic instrumentation: UV/vis; Fourier transform infrared (FTIR) and nuclear magnetic resonance (NMR) spectroscopy.

A quadrupole mass spectrometer will also be included in the array of laboratory instrumentation. When combined with liquid chromatography, this instrument, used in the MS-MS or tandem mass spectrometry modes, will provide powerful analytical resources for drug identification in complex mixtures and under very dilute conditions. Such a mass spectrometry facility is new to Malta and its introduction will provide a powerful research and development platform for the Department of Chemistry.

So the post-graduate course has been a success - but what about the future? To build on the foundations laid down over the past two years, the Board of Studies has recommended - and the Faculty of Science has agreed - that students who successfully complete the diploma course will be able to read for an M.Sc. in Applied Chemistry.

This course's development into an M.Sc. will permit the students to carry out an advanced research project approved by the University but in collaboration with their sponsor. It has always been the intention of the supporting organisations that this course will create spill-over benefits well beyond the confines of the University, encouraging and cementing a closer relationship between the University and the local pharmaceutical industry.

The Department of Chemistry has always been willing to assist, not just in this but in other areas, most notably with the organisation of basic training courses for pharmaceutical factory operators, in conjunction with the ETC over the last three years.

So much confidence has been built by the progress so far that planning for the second intake on the Post-Graduate Diploma (and M.Sc) course, has already started in earnest. It is hoped that there will be increased interest in the second run of the course, not just from the companies currently participating but also by the pharmaceutical companies that have only recently established themselves in Malta.

A call for applications will be held about six months before the course, the timing of which is currently being discussed with the sponsoring organisations.

Meanwhile, it would be useful, especially for administrative and planning purposes, if individuals or companies interested in this course were to contact Nicole Anne Aquilina at the University's Department of Chemistry (Faculty of Science) on tel. number 2340-2275 for more information.

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