Postgraduate Diploma in Pharmaceutical Sciences

Purpose

The purpose of the Postgraduate Diploma in Pharmaceutical Sciences is to provide learners the required knowledge and skills to demonstrate advanced, current and in-depth knowledge at the forefront of research methods and biostatistics, health systems management, health economics, as well as specialised knowledge in the fields of clinical research or medicines regulatory science. Learners will be able to integrate this knowledge comprehensively in the development process of a medicine. As such, the qualification focusses on training learners to obtain employment and/or advancement within their chosen field of specialisation within the pharmaceutical industry. Qualifying learners will have access to the Masters qualifications in Science.

Rationale

Pharmaceutical Science's role within the promotive and preventative fields of health service delivery is highlighted by strategies related to health care practices, products and therapies to support health. The purpose of this Postgraduate Diploma in Pharmaceutical Sciences is to train and deliver highly trained specialised pharmaceutical scientists for the pharmaceutical and related healthcare industries in accordance with the National Skills Development Strategy (NSDS) phase III, the Human Resource Development Strategy for South Africa and the requirements of the Industrial Policy Action Plan.

This qualification is suitable for continuous professional development through encouraging learners to deal with, formulate and resolve more complex theoretical and practice-related tasks through the selection and use of appropriate methods and techniques. It will also provide access to the Master's Degree in Pharmaceutical Sciences.

The Postgraduate Diploma in Pharmaceutical Sciences enables Pharmaceutical Sciences learners to further their professional/specialised qualification in Pharmaceutical Sciences. The qualification is furthermore 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. The qualification serves to strengthen and deepen the learner's knowledge in Clinical Research and Medicine Regulatory Sciences. Consultation with industry stakeholders, via formal discussion at advisory board meetings for Pharmaceutical Sciences qualifications, has specifically revealed the need for specialists in the areas of clinical research, clinical trial monitoring and medicines governance including regulatory affairs.

This qualification demands a high level of theoretical engagement and intellectual independence, as well as the ability to relate pharmaceutical science knowledge to the full scope of the medicines development process, from clinical research through pharmaceutical development and medicines registration and post post-marketing surveillance. A project is required which may be in the form of reporting research under supervision or selected case studies in the chosen elective field.

This qualification is designed to consist of core and elective modules (learners will be required to select one of two options) in order to fulfil the current need for qualified pharmaceutical sciences professionals and is designed for clinical research and drug regulatory associates to enhance their skills and become specialists in their respective fields.

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 the Postgraduate Diploma Pharmaceutical Sciences. Learners may apply as per the institutional policy and applications from learners will be dealt with on an individual basis.

Entry Requirements

The minimum entry requirement for this qualification is

• Advanced Diploma in Pharmaceutical Sciences, NQF Level 7.

This qualification consists of the following compulsory and elective modules at NQF Level 8 totalling 120 Credits.

Compulsory Modules NQF level 8, 48 Credits

• Research Methodology in Life Sciences, 12 Credits.
• Health Care Admin Management II, 12 Credits.
• Basic Applied Epidemiology and Biostatistics, 12 Credits.
• Health Economics, 12 Credits.
• Research Project (topic elective), 30 Credits.

Elective Modules NQF level 8, 42 Credits (Choose one)

• Medicines Regulatory Science, 42 Credits.
• Clinical Research, 42 Credits.

1. Demonstrate advanced, current and in-depth knowledge at the forefront of research methods and biostatistics, health systems management, health economics, as well as specialised knowledge in the fields of clinical research or medicines regulatory science integrate this knowledge comprehensively in the development process of a medicine.
2. Interrogate multiple sources of knowledge in the medicines development and control process with respect to clinical research and medicines regulatory science.
3. Select, apply or transfer appropriate standard procedures, processes or techniques in clinical research and medicines regulatory science.
4. Solve problems using a range of specialised skills to identify, analyse and address complex or abstract problems drawing systematically on the body of knowledge and methods appropriate to the medicines development and control process.
5. Identify and address ethical issues.

6.Critically review the information gathering process, the synthesis of data, evaluation and management of data in the specialised contexts of clinical research and medicines regulatory science in order to develop creative responses to problems and issues.

Associated Assessment Criteria for Exit Level Outcome 1

• Advanced, current and in-depth knowledge at the forefront of research methods and biostatistics, health systems management, health economics, is demonstrated.
• Specialised knowledge in the fields of clinical research or medicines regulatory science is demonstrated and integrated in the development and control process of medicines.
• The ability to engage with a multidisciplinary team and to evaluate the key terms, concepts, facts, principles, rules and theories, research methodologies, methods and techniques relevant to the field of medicines regulatory sciences and clinical research is demonstrated.
• The ability to apply knowledge in the context of the drug development and control process is demonstrated.

Associated Assessment Criteria for Exit Level Outcome 2

• Multiple sources of knowledge in the medicines development and control process with respect to clinical research and medicines regulatory science are interrogated.
• Knowledge and processes of knowledge production is evaluated.

Associated Assessment Criteria for Exit Level Outcome 3

• Understanding of the complexities of a range of methods of enquiry and uncertainties is demonstrated.
• The use of appropriate standard procedures, processes or techniques to unfamiliar problems in clinical research and medicines regulatory science is demonstrated.

Associated Assessment Criteria for Exit Level Outcome 4

• Problems are identified, analysed, addressed and solved using a range of specialised skills, the body of knowledge and methods appropriate to the medicines development and control process.

Associated Assessment Criteria for Exit Level Outcome 5

• Ethical issues are addressed based on critical reflection of the appropriate legislation, ethical and professional values and approaches within the clinical research and medicines regulatory science field.

Associated Assessment Criteria for Exit Level Outcome 6

• The information gathering process, the synthesis of data, evaluation and management of data in the specialised contexts of clinical research and medicines regulatory science in order to develop creative responses to problems and issues, is critically reviewed and reported on in a logical scientific manner.

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, as well as qualification exit level outcomes are met.

Formative assessment may include

• Written reports and assignments.
• Literature reviews.
• Case studies.
• Class presentations.
• Seminars.
• Peer assessments.

Summative assessment will take the form of a research report or reports on selected case studies.