Postgraduate Diploma in Pharmaceutical Regulatory Affairs

Purpose

The purpose of the Postgraduate Diploma in Pharmaceutical Regulatory Affairs is to equip pharmacists with the necessary knowledge and skills to create high-quality applications for the registration of health products, ensuring compliance with National Health and Drug Policies.

The curriculum is carefully structured to cover critical areas such as regulatory frameworks, drug development processes, quality assurance, compliance standards, and pharmacovigilance. By encompassing these essential topics, the qualification will assist graduates gain a comprehensive understanding of the complex and evolving regulatory landscape in the pharmaceutical industry.

The exit level outcomes are designed to demonstrate the competencies and abilities that graduates will possess upon completion. These likely include proficiency in interpreting and applying regulatory guidelines, conducting thorough assessments of health product applications, ensuring adherence to safety and quality standards, and effective communication with regulatory authorities.

By achieving these exit-level outcomes, graduates are well-prepared to enter the labour market as Regulatory Pharmacists, where they can play a crucial role in guiding pharmaceutical companies through the regulatory approval process, ensuring that only safe and effective health products reach the market.

Furthermore, the qualification provides a solid foundation for those who wish to pursue further academic careers. Graduates can continue their journey by pursuing a master's degree, allowing them to deepen their knowledge and potentially take on more advanced roles in pharmaceutical research, policy-making, or regulatory strategy.

The qualification will equip pharmacists with regulatory expertise, enabling them to develop quality applications for health product registration in compliance with regulations and preparing them for successful careers as Regulatory Pharmacists or further academic pursuits.

Rationale

The pharmaceutical industry is among one of the most regulated fields and specialized pharmaceutical professionals or regulatory pharmacists are needed to ensure that drugs and medical products meet certain regulations before they are put on the market. These professionals interface with pharmaceutical companies and scientists to facilitate drug research, plan drug trials and review and interpret scientific report data. They also apply for approvals and permits from government regulatory agencies and pharmaceutical businesses to facilitate the transition from a drug's conception to final approval.

Given the evolving demographic and epidemiological profile of South Africa and the region, a tremendous increase in market growth for generic drug sales is expected. In addition, being the largest market in the region will continue to attract multinational drugmakers looking to develop a foothold in the wider region. The current existing and market forecast has already opened several opportunities for these professionals and there is a limited pool of qualified professionals with necessary expertise in this sector.

Preliminary market analysis was conducted through a small-scale pilot study taking feedback from attendees under scrutiny. An Introductory Pharmaceutical Regulatory Short Course in Medicine Registration was offered in August 2021. The feedback from attendees was taken under scrutiny which revealed an overwhelming interest in regulatory training across various sectors of Pharmacy in South Africa.

Professionals working in this environment are expected to have in-depth and up-to-date knowledge of current requirements and guidelines to fulfil the requirements of regulatory authorities. In South Africa, limited opportunities currently exist for such professionals to pursue postgraduate qualifications for this purpose. As such, the qualification offers candidates a much-needed opportunity to develop their competencies as pharmaceutical regulatory affairs professionals.

Based on the demand for this qualification, the pharmaceutical and related industries and sectors would benefit immensely from the professional services that graduates would be able to offer. In this way, course graduates would not only be able to contribute positively and responsibly to the healthcare sector but also to the South African economy.

Furthermore, the significant evolution in pharmaceutical technologies used in the development, manufacture and distribution of healthcare products has necessitated the parallel development of methods and expertise to control and assess the quality, safety and efficacy of these products. By continuously delivering professionals with the appropriate skills and knowledge to meet these expectations, this qualification has the potential to benefit both the pharmaceutical industry and the South African public.

Recognition of Prior Learning (RPL)

RPL is set out according to CHE and institutional policies. The principles of RPL for access and exemption will apply.

RPL for access

• Learners who do not meet the minimum entrance requirements or the required qualification at the same NQF level as the qualification required for admission may be considered for admission through RPL.
• To be considered for admission in the qualification based on RPL, applicants should provide evidence in the form of a portfolio that demonstrates that they have acquired the relevant knowledge, skills, and competencies through formal, non-formal and/or informal learning to cope with the qualification expectations should they be allowed entrance into the qualification.
• Not more than 10% of a cohort of learners will be admitted through RPL

RPL for credit

• Learners may also apply for RPL for credit for or towards the qualification, in which they must provide evidence in the form of a portfolio that demonstrates prior learning through formal, non-formal and/or informal learning to obtain credits towards the qualification.
• Credit shall be appropriate to the context in which it is awarded and accepted.
• Not more than 50% of the qualification will be awarded for RPL.

Learners who feel that the prior learning and/or experience that they have acquired meet the prescribed requirements of the modules offered should apply by completing the prescribed form together with relevant supporting documentation as determined by the university. Deadlines align with regular application dates. An RPL fee, equivalent to regular application fees, applies. The Enrolment Management Office processes forms, which are then reviewed by Heads of Department and subject experts. Decisions are ratified by the School Board or Dean. Recognition is based on current competency and may include academic support or extended learning options. The school maintains records and reports to the Senate.

Entry Requirements

The minimum entry requirement for this qualification is

• Advanced Diploma in Pharmaceutical Sciences, NQF Level 7.

Or

• Bachelor of Pharmacy, NQF Level 8

Or

• A relevant Bachelor's Honours Degree, NQF Level 8 with a minimum of two years of relevant work experience.

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

Compulsory Modules, Level 5, 120 Credits

• Administrative Information, 20 Credits.
• Enabling Legislation and Licensing, 20 Credits.
• Good Manufacturing Practice (GMP), 20 Credits.
• Other Good Practices, 20 Credits.
• Quality and Bioequivalence, 20 Credits.
• Safety and efficacy, 20 Credits.

1. Demonstrate the ability to interrogate practices and assess processes of the general, regional, and labelling requirements for a health products registration application in compliance with the Medicines and Related Substance Act, 1965 (Act 101 of 1965), the Pharmacy Act, 1974 (Act 53 of 1974), and the South African Health Products Regulatory Affairs (SAHPRA) Guidelines and in line with the National Health and the National Drug Policies.
2. Demonstrate knowledge of and engagement with other relevant legislation of the registration and control of health products (medicines, medical devices and IVDs).
3. Demonstrate the ability to use a range of specialised skills to analyse, evaluate and justify good manufacturing practice (GMP) aspects to obtain positive GMP compliance status for the registration and control of health products.
4. Demonstrate the ability to access, process, manage and critically review information in compiling the licence and permit applications in compliance with the Medicines and Related Substances Act, 1965 (Act 101 of 1965), Pharmacy Act, 1974 (Act 53 of 1974), and the SAHPRA Guidelines, in line with the National Health and National Drug Policies required for the Health Products Industry.
5. Demonstrate an understanding and engagement with appropriate risk-based science to construct the procedures, processes and/or techniques in pharmaceutical regulatory affairs.
6. Demonstrate the ability to critically engage with researched information and address scientific and/or technical challenges within pharmaceutical regulatory affairs.

Associated Assessment Criteria for Exit Level Outcome 1

• Describe and examine the need for medicine regulation.
• Apply knowledge specific to South African and international requirements, to convert historical registration applications to the current application form for South African registration of medicines.
• Display and apply in-depth knowledge specific to South African requirements to compile regional-specific information on the medicine registration application form.
• Apply knowledge of the SAHPRA Authority framework to compile and submit applications and respond to assessment outcomes to SAHPRA.
• Construct appropriate safety and efficacy measures for African Traditional medicines in any one therapeutic area.

Associated Assessment Criteria for Exit Level Outcome 2

• Identify and interpret the legislation applicable to all aspects of the registration and control of health products (medicines, medical devices and IVDs) to defend compliance therewith.
• Identify and interpret the legislation applicable to the pricing of medicines (CMs, medical devices and IVDs exempt) to compile pricing applications, and responses to assessment outcomes.
• Contrast and examine any legislation applicable to African Traditional Medicines.

Associated Assessment Criteria for Exit Level Outcome 3

• Identify, locate, and describe the international GMP guides and related documents.
• Identify and summarise the South African GMP chapters and the Annexes for medicinal products and active pharmaceutical ingredients.
• Appraise the applicability of Quality Risk Management (QRM) tools in manufacturing scenarios to implement QRM.
• Identify and interpret the appropriate GMP requirements for the manufacture of high-, medium-, and low-risk pharmaceutical dosage forms.
• Create and defend appropriate collection, processing, manufacturing, storage, and distribution guidelines for African Traditional medicines of any one type/dosage form in any one therapeutic area.

Associated Assessment Criteria for Exit Level Outcome 4

• Identify and describe all the licence and permit applications applicable for Health Products in South Africa.
• Apply knowledge specific to South African requirements to prepare and defend all the licence and permit applications applicable to the health products industry.
• Demonstrate knowledge of the authority frameworks to compile and submit licence and permit applications to SAHPRA, the SAPC and the Department of Health, Customs and Excise.

Associated Assessment Criteria for Exit Level Outcome 5

• Construct the pharmaceutical quality specifications and requirements for different dosage forms, and administration methods of medicines.
• Construct a list of different sources and types of dosage forms and administration methods of African Traditional Medicines.

Associated Assessment Criteria for Exit Level Outcome 6

• Differentiate between and resolve value-added and non-value-added regulatory technical and administrative/procedural queries.
• Justify the appropriateness of requirements for various dosage forms and/or medicines using risk-based scientific reasoning.

INTEGRATED ASSESSMENT

As set out in the institutional assessment policy, formative assessment will be utilised within each module as set out in the relevant module descriptor. Formative assessment facilitates learning and the required competencies to successfully complete the outlined summative requirements of each module.

The assessment strategy includes assignments that are open-ended problem-solving tasks, and the use of feedback sessions after formative assessment to ensure constructive learning opportunities for learners.

In addition, the quizzes and tests carried out will use case studies that would require the use of knowledge gained, connect between one piece of knowledge and another and provide reasoning. The assessment strategy is further supported by comprehensive assessment plans for each module as set out in the module descriptors.

As required by the institution, formative assessment for each module will comprise 60% of the final module mark and summative assessment 40%. Assessments are aligned with the institution's Assessment Policy and General Academic Rules.