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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED QUALIFICATION: 

Advanced Diploma in Pharmaceutical Sciences 
SAQA QUAL ID QUALIFICATION TITLE
110727  Advanced Diploma in Pharmaceutical Sciences 
ORIGINATOR
Tshwane University of Technology (TUT) 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY NQF SUB-FRAMEWORK
CHE - Council on Higher Education  HEQSF - Higher Education Qualifications Sub-framework 
QUALIFICATION TYPE FIELD SUBFIELD
Advanced Diploma  Field 09 - Health Sciences and Social Services  Promotive Health and Developmental Services 
ABET BAND MINIMUM CREDITS PRE-2009 NQF LEVEL NQF LEVEL QUAL CLASS
Undefined  120  Not Applicable  NQF Level 07  Regular-Provider-ELOAC 
REGISTRATION STATUS SAQA DECISION NUMBER REGISTRATION START DATE REGISTRATION END DATE
Reregistered  EXCO 0821/24  2019-09-11  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 does not replace any other qualification and is not replaced by any other qualification. 

PURPOSE AND RATIONALE OF THE QUALIFICATION 
Purpose:
This is a vocational learning qualification providing training for health sciences practitioners for academic deepening and/or career change. Qualifying learners will attain knowledge in the fields of drug development processes, pharmacology and bio-pharmaceutics as well as applicable legislation in the Pharmaceutical industry. As such, the qualification has been widely accepted by the Pharmaceutical Industry and focuses on training learners, getting employment and/or advancement within their chosen field of specialisation within industry. This qualification provides for access to the Postgraduate Diploma in Pharmaceutics.

Qualifying learners will be able demonstrate integrated knowledge in the fields of biopharmaceutics, pharmacology, pharmaceutical development, clinical research, Good Manufacturing Practices, and drug regulatory process.

Rationale:
Pharmaceutical Sciences' role within the promotive and preventative fields of health service delivery is highlighted into strategies related to health care practices, products and therapies to support health. This qualification is suitable for continuous professional development through encouraging learners to formulate and resolve more complex theoretical and practice-related tasks through the selection and use of appropriate methods and techniques. This qualification is also designed to prepare learners for postgraduate study through deepening their knowledge and understanding of current thinking, practice, theory and methodology in Pharmaceutical Sciences.

The Pharmaceutical Scientist will be expected to promote health and wellness through complementary approaches that complement conventional medical care. This qualification will enable qualifying learners to further their professional/specialised qualification in Pharmaceutical Sciences. The qualifying learner is in line with government policies to provide necessary professional career paths for learners to get access to higher education qualifications in health professions and related clinical sciences.

This qualification came into existence in 2001 at the request of industry leaders in the pharmaceutical, clinical research and regulatory sciences to provide a qualification for persons working in the broader pharmaceutical industry. An advisory committee has been established which has been instrumental in the establishing of the programme and its continuous improvement. Learners typically possess a Degree/Diploma in a health science who is employed within the pharmaceutical industry or who wishes to enter the pharmaceutical industry. As such a diverse range of learner qualifications are accepted for learners to make vocational changes.

The base qualification, Pharmaceutical Sciences, will enable learners to find employment in the Pharmaceutical Industry as clinical trial monitors, regulatory associates and quality assurance specialists in pharmaceutical manufacturing. This qualification articulates with the Postgraduate Diploma in Pharmaceutical Sciences. 

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
Recognition of Prior Learning (RPL):
The institutional Policy on Recognition of Prior Learning (RPL) will be followed for prospective learners who intend to apply for credits towards this qualification.

The structure of this qualification makes the Recognition of Prior Learning possible. Recognition of Prior Learning includes formal, informal and non-formal learning and work experience in the field of pharmaceutical sciences. The learner will be thoroughly briefed on the mechanism to be used and support and guidance will be provided.

Structured means for the assessment of the level of achievement (practical as well as theoretical) of individual learners against the Exit Level Outcomes of the qualification will be performed in-line with the RPL Policy of the institution, on a case-by-case basis. Such procedures, and the assessment of individual cases, are subject to moderation by independent assessors. The necessary evidence as required by the Exit Level Outcomes, and presented by the learner, should meet the following principles: currency of evidence, sufficiency of evidence, validity of evidence and authenticity of evidence. Care will be taken that the mechanism used provides the learner with an opportunity to demonstrate competence and is not so onerous as to prevent learners from taking up the RPL option towards gaining qualification.

Learners may apply at the Office of the Registrar for RPL admission. The specific relevant documentation will be requested from these learners, and these cases will be handled on an individual basis. Furthermore, the institutional policy on RPL will be followed for prospective learners who intend to apply for credits towards the qualification.

Entry Requirements:
The minimum entry requirement for this qualification is:
  • Diploma in Health Sciences or related qualification, National Qualifications Framework (NQF) Level 6, 360 Credits. 
    		•

    RECOGNISE PREVIOUS LEARNING? 
    Y 

    QUALIFICATION RULES 
    This qualification consists of the following compulsory modules at Level 7 totalling 120 Credits.

    Compulsory Modules, Level 7,120 Credits:
  • Biopharmaceutics and Pharmacology, 24 Credits.
  • Pharmaceutical Development Process, 24 Credits.
  • Quality of Medicines, 24 Credits.
  • Medicine Governance, 24 Credits.
  • Clinical Research, 24 Credits. 
    		•

    EXIT LEVEL OUTCOMES 
    1. Demonstrate integrated knowledge in the fields of Pharmacology, Pharmaceutical Development, Clinical Research, Good Quality Manufacturing Practices, Pharmacology Drug Regulatory Processes, including an understanding of and an ability to apply and evaluate the key terms, concepts, facts, principles, rules and theories within the context of drug development processes.
    2. Understand a range of methods of enquiry in the field of drug development process and medicines governance, including identifying, analysing, evaluating and addressing complex problems related to the field.
    3. Ability to take decisions and act ethically and professionally, and the ability to justify those decisions and actions drawing on appropriate legislation, ethical values and approaches within a supported pharmaceutical environment.
    4. Ability to develop appropriate processes of information gathering within the field of drug development process, independently validate the sources of information, evaluate, manage and communicate the information in well-formed arguments, using appropriate academic, professional, or occupational discourse.
    5. Identify, evaluate and address own learning needs in a self-directed manner, and to facilitate collaborative learning processes in the field of drug development processes and medicines governance.
    6. Demonstrate an ability to take full responsibility for own work, decision-making and use of resources. 

    ASSOCIATED ASSESSMENT CRITERIA 
    Associated Assessment Criteria for Exit Level Outcome 1:
  • Outline and explain the drug development cycle.
  • Define, explain and classify basic pharmacology and drug classes.
  • Explain Biopharmaceutics and the interaction of drugs with the body.

    Associated Assessment Criteria for Exit Level Outcome 2:
  • Explain and apply knowledge in the drug development process and the impact it has on drug registration process.

    Associated Assessment Criteria for Exit Level Outcome 3:
  • Explain and apply current legislation in the context of clinical research, medicine governance, Quality of medicines such as the International Conference on Harmonisation (ICH); Good Manufacturing Practices (South Africa (S.A) Good Manufacturing Practice (GMP)); Medicines and Related Substances Act (Act 101 of 1965 as amended); Pharmacy Act 53 of 1974; and Marketing Code of Practice.

    Associated Assessment Criteria for Exit Level Outcome 4:
  • Review current trends in the fields of study by researching of appropriate sources of information.
  • Research, validate and communicate information in the field of drug development processes in PowerPoint presentations.

    Associated Assessment Criteria for Exit Level Outcome 5:
  • Provide a learning report to identify, evaluate and address own learning needs and to facilitate collaborative learning processes in the field of drug development processes and medicines governance.

    Associated Assessment Criteria for Exit Level Outcome 6:
  • Demonstrate the use of resources in Bio pharmaceutics and Pharmacology, Clinical Research, quality of medicines, Pharmaceutical Development Process and Medicines Governance.

    Integrated Assessment:
    Assessments will focus on the learners' ability to demonstrate applied knowledge and competence. Evidence of applied competence will be evident in the learners' ability to integrate concepts, ideas and actions in authentic, real-life contexts, and will be expressed as practical, foundational and reflexive competence.

    Formative and Summative Assessment strategies will be used throughout the qualification to ensure that module outcomes, according to specific study year outcomes, as well as Exit Level Outcomes are met.

    Formative Assessment may include:
  • Tests.
  • Written and assignments.
  • Literature reviews.
  • Case studies.
  • Class presentations.
  • Seminars.
  • Peer evaluation.
  • Simulations in structured learning environments.

    Summative Assessment may include:
  • Written examinations.
  • Oral examinations. 
    		•

    INTERNATIONAL COMPARABILITY 
  • Country: United States of America (USA).
  • Institution: Purdue University.
  • Qualification Title: Bachelor's Degree in Pharmaceutical Sciences.

    This qualification is similar to the qualification offered by the above country in terms of the following:
    The Bachelor's Degree in Pharmaceutical Sciences is a four-year Bachelor's Degree. The first three years are equivalent to a Bachelor's Degree in Health Science in South Africa (S.A). and the final year is equivalent to the modules covered in the Advanced Diploma in Pharmaceutical Sciences.
  • Country: Australia.
  • Institution: Monash University.
  • Qualification Title: Bachelor's Degree in Pharmaceutical Sciences.

    This qualification is similar to the qualification offered by the above country in terms of the following:
    This qualification from Monash University is a three-year full time programme in pharmaceutical sciences (6 years part-time). The first year covers the foundation studies in bioorganic and medicinal chemistry, physical chemistry and physiology. The subsequent years covers pharmaceutical Sciences and an area of specialisation and a research project. The advanced Diploma is equivalent to the Pharmaceutical Sciences portion of the Monash Bachelors in Pharmaceutical Sciences Degree. 
    		•

    ARTICULATION OPTIONS 
    This qualification allows possibilities for both horizontal and vertical articulation.

    Horizontal Articulation:
  • Advanced Diploma in Health Management, Level 7.

    Vertical Articulation:
  • Postgraduate Diploma in Pharmaceutical Sciences, Level 8. 
    		•

    MODERATION OPTIONS 
    N/A 

    CRITERIA FOR THE REGISTRATION OF ASSESSORS 
    N/A 

    NOTES 
    N/A 

    LEARNING PROGRAMMES RECORDED AGAINST THIS 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.
     
    1. Tshwane University of Technology (TUT) 


    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.