Advanced Diploma in Pharmaceutical Sciences
Health Sciences and Social Services - Promotive Health and Developmental Services
Purpose and Rationale
Purpose:
This vocational learning qualification aims to provide training for health sciences practitioners seeking academic deepening or a career change. The key focus areas include knowledge in drug development processes, pharmacology, bio-pharmaceutics, and applicable legislation within the Pharmaceutical industry. It is widely recognized by the Pharmaceutical Industry and aims to train learners for employment or advancement within their chosen specialization in the industry. Successful completion of this qualification also provides access to the Postgraduate Diploma in Pharmaceutics.
Qualified learners will demonstrate integrated knowledge in biopharmaceutics, pharmacology, pharmaceutical development, clinical research, Good Manufacturing Practices, and drug regulatory processes.
Rationale:
Pharmaceutical Sciences play a crucial role in promotive and preventative healthcare delivery by developing strategies related to healthcare practices, products, and therapies to support health. This qualification encourages continuous professional development by challenging learners to tackle complex theoretical and practice-related tasks using appropriate methods and techniques. It is designed to prepare learners for postgraduate study by deepening their knowledge and understanding of current thinking, practice, theory, and methodology in Pharmaceutical Sciences.
Pharmaceutical Scientists are expected to promote health and wellness through complementary approaches that enhance conventional medical care. This qualification allows learners to further their professional/specialized qualification in Pharmaceutical Sciences, aligning with government policies to provide career paths for accessing higher education qualifications in health professions and related clinical sciences.
Established in 2001 at the request of industry leaders in pharmaceutical, clinical research, and regulatory sciences, this qualification addresses the needs of individuals employed in the pharmaceutical industry or seeking to enter it. An advisory committee plays a key role in program development and continuous improvement. Learners with a Degree/Diploma in a health science background or those employed in the pharmaceutical industry are typically accepted. A diverse range of learner qualifications is considered for those looking to make vocational changes.
By completing the base qualification in Pharmaceutical Sciences, learners can pursue roles such as clinical trial monitors, regulatory associates, and quality assurance specialists in pharmaceutical manufacturing. This qualification also serves as a pathway to the Postgraduate Diploma in Pharmaceutical Sciences offering further specialization.
Outcomes
- 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.
- 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.
- 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.
- 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.
- 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.
- Demonstrate an ability to take full responsibility for own work, decision-making and use of resources.
Assessment Criteria
Associated Assessment Criteria for Exit Level Outcome 1:
- Outline and explain the drug development cycle: Learners should be able to describe the stages involved in drug development from discovery to market approval.
- Define, explain and classify basic pharmacology and drug classes: Learners should be able to define key pharmacology terms and classify drugs based on their mechanism of action.
- Explain Biopharmaceutics and the interaction of drugs with the body: Learners should understand how drugs are absorbed, distributed, metabolized, and excreted in 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: Learners should be able to demonstrate an understanding of how the drug development process influences the registration of new drugs.
Associated Assessment Criteria for Exit Level Outcome 3:
- Explain and apply current legislation in the context of clinical research, medicine governance: Learners should be able to interpret and apply legislation such as ICH guidelines, GMP regulations, Medicines and Related Substances Act, Pharmacy Act, 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: Learners should be able to identify and analyze current trends in drug development through research.
- Research, validate and communicate information in the field of drug development processes in PowerPoint presentations: Learners should be able to effectively communicate their research findings in a PowerPoint presentation format.
Associated Assessment Criteria for Exit Level Outcome 5:
- Provide a learning report to identify, evaluate and address own learning needs: Learners should be able to reflect on their learning needs and develop strategies to address them.
- Facilitate collaborative learning processes in the field of drug development processes and medicines governance: Learners should be able to engage in collaborative learning activities with peers to enhance their understanding of drug development processes.
Associated Assessment Criteria for Exit Level Outcome 6:
- Demonstrate the use of resources in Bio pharmaceutics and Pharmacology: Learners should demonstrate the effective utilization of resources in the fields of Bio pharmaceutics and Pharmacology.
- Demonstrate the use of resources in Clinical Research, Quality of medicines, Pharmaceutical Development Process and Medicines Governance: Learners should also demonstrate proficiency in utilizing resources related to clinical research, quality of medicines, pharmaceutical development process, and medicines governance.
Integrated Assessment:
- Formative Assessment strategies: Tests, written assignments, literature reviews, case studies, class presentations, seminars, peer evaluation, simulations in structured learning environments.
- Summative Assessment strategies: Written and oral examinations to assess learners' applied knowledge and competence.
Qualification Details
- Type
- Advanced Diploma
- NQF Level
- 07
- Min. Credits
- 120
- SAQA Source
- More Information
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