Postgraduate Diploma in Pharmaceutical Medicine

Purpose

This Postgraduate Diploma: Pharmaceutical Medicine programme is aimed at producing scientists who are suitably equipped to conduct research and drug development. Pharmaceutical Medicine has its own body of knowledge and own special skills related to the science and formal aspects of drug development and regulatory affairs, as well as research areas in Pharmaceutical Medicine.

The course will be specifically structured in terms of lectures and tutorials, to be presented in well-defined three-day sections, every three months and which include electronic and telematic components to accommodate students from outside the Western Cape, as well as those from disadvantaged backgrounds and those with learning support requirements.

The Postgraduate Diploma: Pharmaceutical Medicine (PGDip Pharm Med) programme will appeal to graduates with an interest in Drug Development and Pharmaceutical Medicine, and will equip them for further studies towards a professional and/or academic career as a medical scientist.

Rationale

In recent years, the discipline of Pharmaceutical Medicine has experienced an explosive growth both globally and locally. This has created a growing demand in academia, the public sector, the private sector and industry for suitably trained scientists who are skilled to conduct research and drug development. Consequently, numerous training programmes (resulting in Masters or Doctoral qualifications in Pharmaceutical Medicine) have evolved in Europe, the United Kingdom, Australia and United States of America. However, in South Africa at present, no specific programme caters for this unique niche market.

The proposed programme will provide an essential step in addressing an obvious need through the training of medical scientists in Pharmaceutical Medicine. The target group will include suitably qualified Bachelor of Science or Bachelor of Medicine and Bachelor of Surgery (MBChB) graduates, or equivalents, and will include students from other African countries.

Research areas in Pharmaceutical Medicine are very specific for the Industry requirements for efficient drug development. New research in drug development is strongly driven by the Food and Drug Administration's Critical Path Initiative and by the Innovative Medicines Initiative in Europe. The European Federation for Pharmaceutical Sciences (EUFEPS) is a pan-European organisation that has specifically been founded to "serve and advance excellence in the pharmaceutical sciences and innovative drug research".

To date, no equivalent course exists anywhere in Africa. The discipline of Pharmaceutical Medicine is loosely organised in South Africa, with the South African Clinical Research Association (SACRA) organising regular conferences. Concern has, however, been expressed about the lack of standardised and quality training which influences the standards of the work being done in the discipline in South Africa and the rest of Africa. Informal discussions between members of the Medicines Control Council (MCC), SACRA and the Pharmaceutical industry have indicated that there is a strong need for formal training in Pharmaceutical Medicine in our country. This has been confirmed by the very positive feedback to a South African preliminary market research survey conducted amongst pharmaceutical companies and Clinical Research Organisations. Currently, a number of pharmaceutical companies send their staff to be trained in Ireland or the United Kingdom, and would thus welcome an equivalent South African course.

In summary, the proposed programme will provide an essential step in the training of medical scientists in Pharmaceutical Medicine and addresses an obvious need that has been globally recognised. The target group will include suitably qualified graduates drawn from across the African Continent.

• A Bachelor of Medicine and Bachelor of Surgery (MBChB).

Or

• A Bachelor of Science with major subjects in Pharmacology and Biology.

Or

• Any four-year Bachelor's degree in related Health Sciences degree.

Recognition of Prior Learning

Learners may provide evidence of prior learning for which they may receive credit towards the qualification by means of portfolios or other forms of appropriate evidence which may include, verified accounts of previous relevant work done and performance records and which evidence is in accordance with the requirements of the University Senate and the relevant Quality Council.

Access to the Qualification

Students with other major subjects in the Biological Sciences at third year level may also be considered for admission to the programme pending an adequate motivation and admission examination. Depending on the field of study, additional work and/or proof of competency may also be required.

The programme comprises four taught and one research module, all of which are compulsory and must be completed for the Qualification to be awarded.

• Three of the taught modules carry 24 Credits each.
• One taught module carries 18 Credits.
• The research module carries 30 Credits.

Total Credits required: 120.

In order to successfully achieve this Qualification, the student must

• Complete two calendar years as a registered student for the Postgraduate Diploma: Pharmaceutical Medicine.
• Obtain at least 50% in all modular tests throughout the duration of the two-year course.
• Successfully complete and submit a relevant research project.

1. Critically evaluate and practically apply new knowledge, understanding and skills to the field of Pharmaceutical Medicine in South Africa.
2. A research project related to the field of pharmaceutical medicine is developed.

Critical Cross-Field Outcomes

All the Critical Cross-Field Outcomes have been addressed in this qualification.

Associated Assessment Criteria for Exit Level Outcome 1

1.1 The principles of pharmacodynamics and pharmacokinetics are integrated and applied in pharmaceutical development.

1.2 Integrated knowledge of toxicology is applied in pharmaceutical development to ensure good manufacturing and laboratory practices.

1.3 The planning, design, documentation, analysis, reporting and monitoring of clinical drug trials are applied to ensure Good Clinical Practice (GCP).

1.4 The principles of pharmaceutical care are applied to ensure safety of medicines and pharmacovigilance.

1.5 The regulatory framework for drug development is consistently applied to ensure ethical product production and Good Manufacturing Practice (GMP).

1.6 Reliable sources of epidemiological statistics are accessed to develop an accurate database of probable research areas.

1.7 The principles of pharmaco-economics are applied in the provision cost-effective and efficient therapy.

Associated Assessment Criteria for Exit Level Outcome 2

2.1 The relevant literature is systematically searched and assessed.

2.2 An appropriate research project is designed to critically analyse the data.

2.3 Valid evidence-based conclusions are formulated.

2.4 The results are presented in a scientific format, in compliance with requirements of regulatory authorities.

2.5 The work performed conducted ethically and responsibility and accountability for the work produced is accepted.

Integrated Assessment

Formative Assessment

Assessment is appropriately incorporated to ensure that the purpose of the qualification is achieved. It is required that the student should obtain at least 50% in all modular tests during the duration of the course.

Summative Assessment

Successful completion of the research project is a prerequisite for awarding the degree.

A written report must be submitted and an oral presentation delivered on completion of the research assignment.

Such a report and oral presentation (in the presence of an external examiner) must provide proof that the student is capable of:

• Planning research.
• Applying a thorough literature study to the research project.
• Performing the research.
• Applying elementary statistical principles.
• Analysing results and arrive at meaningful conclusions.
• Compile a written report on the project.

The pass mark will be 50% and a mark of 75% will be required to pass with distinction. The final mark will be made up of a weighted average of the marks for each component namely:

• Two 3 hours written papers (2 x 30%); 60%.
• Research assignment and its oral presentation; 25%.
• Oral examination in the presence of an external examiner; 15%.

Where a candidate fails to achieve an overall mark of 50% for the examination, the examiners may recommend that the student be exempted from repeating one or more of the sections of the examination (above). In such cases, the marks for the exempted sections must be carried forward to the next attempt and a distinction may not be awarded at that attempt. If the candidate is still unsuccessful (i.e. aggregate mark is still below 50%) then the entire examination must be repeated at the following opportunity.

The Academic Planning Committee monitors the accuracy of the levels of the academic programmes presented at the Stellenbosch University.