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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED QUALIFICATION: 

Postgraduate Diploma in Medicines Development 
SAQA QUAL ID QUALIFICATION TITLE
118506  Postgraduate Diploma in Medicines Development 
ORIGINATOR
Stellenbosch University 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY NQF SUB-FRAMEWORK
-   HEQSF - Higher Education Qualifications Sub-framework 
QUALIFICATION TYPE FIELD SUBFIELD
Postgraduate Diploma  Field 09 - Health Sciences and Social Services  Curative Health 
ABET BAND MINIMUM CREDITS PRE-2009 NQF LEVEL NQF LEVEL QUAL CLASS
Undefined  120  Not Applicable  NQF Level 08  Regular-Provider-ELOAC 
REGISTRATION STATUS SAQA DECISION NUMBER REGISTRATION START DATE REGISTRATION END DATE
Reregistered  EXCO 0821/24  2021-07-01  2027-06-30 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2028-06-30   2031-06-30  

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.  

This qualification replaces: 
Qual ID Qualification Title Pre-2009 NQF Level NQF Level Min Credits Replacement Status
83306  Postgraduate Diploma in Pharmaceutical Medicine  Not Applicable  NQF Level 08  120  Complete 

PURPOSE AND RATIONALE OF THE QUALIFICATION 
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. 

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
Recognition of Prior Learning (RPL):
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.

Entry Requirements:
  • 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.

    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. 
    		•

    RECOGNISE PREVIOUS LEARNING? 
    Y 

    QUALIFICATION RULES 
    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. 
    		•

    EXIT LEVEL OUTCOMES 
    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 
    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. 
    		•

    INTERNATIONAL COMPARABILITY 
    This qualification has been compared to the qualifications given below and has been found to be on a par with them all:
  • Postgraduate Diploma in Pharmaceutical Medicine, offered by St James Hospital and Dublin University, Ireland.
  • Postgraduate Diploma in Pharmaceutical Medicine, offered by the University of Ulster, Northern Ireland.
  • Graduate Diploma in Pharmaceutical Medicine, offered by the University of New South Wales, New Zealand. 
    		•

    ARTICULATION OPTIONS 
    This Qualification articulates horizontally with:
  • Any other Postgraduate Diploma or Honours programme in areas such as Pharmacology, Chemistry, Biology, or any other area which would be acceptable to the relevant provider.

    The Qualification articulates vertically with:
  • Any Master's Degree in a relevant field of study. 
    		•

    MODERATION OPTIONS 
  • Providers offering learning towards this Qualification or the component unit standards must be accredited by the relevant Quality Council (QC).
  • Moderation of assessment will be overseen by the relevant QC in accordance with the agreed on moderation requirements of the providing institution.
  • Internal and external moderation must be conducted by moderators appointed by the provider in agreement with the relevant QC.
  • Both internal and external moderators must be in possession of an appropriate qualification, as well as relevant clinical expertise and current experience. 
    		•

    CRITERIA FOR THE REGISTRATION OF ASSESSORS 
    N/A 

    NOTES 
    N/A 

    LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION: 
    When qualifications are replaced, some (but not all) of their learning programmes are moved to the replacement qualifications. If a learning programme appears to be missing from here, please check the replaced qualification.
     
    NONE 


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION: 
    This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.
     
    NONE 


    All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.