Higher Occupational Certificate: Health Products Regulatory Assistant (HPRA)

Purpose

The purpose of Higher Occupational Certificate: Health Products Regulatory Assistant (HPRA) is to prepare a learner to function as a Health Products Regulatory Assistant (HPRA). A Health Products Regulatory Assistant (HPRA) prepares, collates and submits various applications for the registration of health products, for amendments/variations on registered health products and for the renewal of licences for health products, under the supervision of either a responsible pharmacist or authorised representative. Health products include medicines, medical devices and in vitro devices (IVDs), veterinary and personal care products. These applications are submitted to the regulatory body electronically in the main. A HPRA also conducts compliance activities to ensure that promotional material and activities meet the requirements of the legal framework. A HPRA assists with vigilance and post marketing surveillance of the health products.

A qualified learner will be able to

• Apply for licences for healthcare establishments and registration of health products.
• Apply for renewals, amendments/ variations and retentions.
• Conduct / perform code compliance activities on health products.
• Conduct / perform vigilance and post marketing surveillance.

Achieving this Health Products Regulatory Assistant (HPRA) qualification will provide several benefits to the learner, including:

• Being able to carry out a range of regulatory-related activities for health products, including preparing, collating and submitting various applications for the registration and licensing of health products, amendments/variations to registered and licensed health products and licences for health products, conducting code compliance activities with respect to promotional material and activities, and conducting vigilance and post marketing surveillance of health products.
• Acquiring in-depth knowledge of the health products regulatory requirements and related processes.
• Taking a significant step into the health products sector with the prospect of acquiring higher qualifications in the field.
• Acquisition of a formal qualification in health products regulatory environment if they do not already have a qualification.
• Increasing the opportunity of gaining employment with companies that manage health product applications for registration and licensing. Considering South Africa's huge unemployment rate, a qualification like this has the potential to get learners into meaningful employment. This qualification will ensure the speedy registration and updating of health products, in companies getting their renewals for health products and in vigilance officers getting trained.

Typical graduate attributes include proficiency, efficiency, and effectiveness in preparing dossiers for registration and renewal of health products. The Health Products Regulatory Assistant (HPRA) is a person of integrity and high ethical standards as they work within a regulatory framework to ensure the registration and licencing of health products that are safe to use.

Rationale

No health product may be sold in South Africa unless it has been registered with an appropriate regulatory body. This qualification covers medicines, medical devices and In Vitro Devices (IVDs), complementary and over the counter (OTC) medicines, personal care products and veterinary products. Currently, the South African Health Products Authority (SAHPRA) registers health products as defined by the Medicines Act 101 of 1965 and its Amendments, whether they are manufactured locally or abroad, to ensure safety, efficacy, and quality

According to the SAHPRA website, when a health product based on its category as defined by the Medicines Act 101 of 1965 and its Amendments, is first registered and made available in South Africa, information about its safety and effectiveness is usually only available from clinical trials. Clinical trials provide information about many of the possible adverse events associated with a health product prior to it being made available to the public, but these trials do not detect all possible adverse events until post marketing. SAHPRA monitors the safety of health products to contribute to a better understanding of their possible adverse events when they are used outside the controlled conditions of clinical trials.

The Health Products Regulatory Assistant (HPRA) plays a critical role in assisting either a Responsible Pharmacist (RP) in the case of medicines or an Authorised Representative (AR) in the case of medical devices or IVDs to review and prepare applications on health products for submission to SAHPRA for registration in the case of medicines and licensing in the case of medical technology devices. There is no registered health product regulatory qualification currently; this is the first time a qualification for this regulatory occupation or role is being developed. The qualification also incorporates two-part qualifications: Health Products Vigilance Compliance Officer and Health Products Code Compliance Officer. The latter two occupations, which have their genesis in industry codes of practice, also do not have formal qualifications on which learners can be trained.

As the number of health products grows significantly in view of scientific advancement (the plethora of health products being a case in point), the Health Products Regulatory Assistant qualification becomes critical to both fulfil the needs of the country for health products and standardise current but disparate training offered by companies dealing in health products.

Another significant aspect is that the qualification will contribute to ensuring that there are trained individuals who will ensure that health products are safe to use. HPRAs will be qualified to apply health products regulatory authority's safety criteria for health products for registration and licencing purposes.

The qualification has the potential of creating employment as it is needed in the industry and there is a potential uptake of the qualification by significant number of learners. Increased employment will translate into increased benefits for the economy.

Typical learners will be those currently practising as Health Products Regulatory Assistants without having obtained a formal recognised qualification and school leavers wishing to enter the health products regulatory field. Learners working towards this qualification will find that the acquisition of competencies embedded in the modules will either enable them to obtain employment or add value to their job performance if they are already employed.

In the development of this qualification, a range of stakeholders from the health products sector were consulted, including:

• Training providers.
• Regulator.
• Employers/employer organisations.

There are no similar Qualification(s) and Part-Qualifications registered on the NQF, and no Skills Programmes approved by the QCTO.

Recognition of Prior Learning (RPL)

RPL for Access to Training

Learners may use the RPL process to gain access to training opportunities for a qualification if they do not meet the formal, minimum entry requirements for admission. RPL assessment provides an alternative access route into a qualification.

Such an RPL assessment may be developed, moderated and conducted by the accredited Skills Development Provider which offers that specific qualification. Such an assessment must ensure that the learner is able to display the equivalent level of competencies required for access, based on the NQF level descriptors.

RPL for Access to the External Integrated Summative Assessment (EISA)

For exemption from modules through RPL, learners who have gained the stipulated competencies of the modules of a qualification through any means of formal, informal or non-formal learning and/or work experience, may be awarded credits towards relevant modules, and gaps identified for training, which is then concluded.

Entry Requirements

An NQF Level 4 qualification, with Mathematics and Science.

This qualification is made up of compulsory Knowledge, Practical Skill and Work Experience Modules

Knowledge Modules

• 242213-001-00-KM-01, Overview of Current Health Products Industry/Sector, Level 5, 5 Credits.
• 242213-001-00-KM-02, Anatomy and Physiology, Level 5, 10 Credits.
• 242213-001-00-KM-03, Health Products, Level 5, 8 Credits.
• 242213-001-00-KM-04, Science for the Health Product Regulatory Assistant (HPRA), Level 5, 3 Credits.
• 242202-001-00-KM-05, Codes of Practice for HPRAs, Level 5, 3 Credits.
• 242213-001-00-KM-06, Registrations, Licensing, Applications, and Submissions, Level 5, 8 Credits.
• 243302-001-00-KM-07, Vigilance and Post Marketing Surveillance, Level 5, 6 Credits.
• 242213-001-00-KM-08, Professional Conduct, Level 4, 3 Credits.

Total number of credits for Knowledge Modules: 46

Practical Skill Modules

• 242213-001-00-PM-01, Submit Health Product Related Applications to the Regulatory Body, Level 5, 18 Credits.
• 242213-001-00-PM-02, Conduct Compliance Activities on Health Products, Level 5, 6 Credits.
• 242213-001-00-PM-03, Conduct Oneself Professionally and Ethically, Level 4, 3 Credits.
• 242213-001-00-PM-04, Perform Vigilance and Post Marketing Surveillance, Level 5, 5 Credits.
• 242213-001-00-PM-05, Communicate, Attend Meetings and Solve Problems, Level 4, 8 Credits.

Total number of credits for Practical Skill Modules: 40

Work Experience Modules

• 242213-001-00-WM-01, Processes to Submit Health Product Registration or Licensing Applications to a Regulatory Authority, Level 5, 20 Credits.
• 242213-001-00-WM-02, Processes to Submit to a Regulatory Authority an Application for Amendment/Variation to a Registered or Licensed Health Product, 5 Level, 8 Credits.
• 242213-001-00-WM-03, Processes to Submit the Health Product Establishment's Licensing Applications to a Regulatory Authority, Level 5, 8 Credits.
• 242213-001-00-WM-04, Processes to Conduct Code Compliance Activities on Health Products, Level 5, 6 Credits.
• 242213-001-00-WM-05, Processes to Perform Vigilance and Post Marketing Surveillance, Level 5, 6 Credits.

Total number of credits for Work Experience Modules: 48

1. Apply essential methods, procedures and techniques to submit applications pertaining to licences of healthcare establishments and registration of health products.
2. Apply essential methods, procedures and techniques to submit applications pertaining to renewals, amendments/ variations and retentions.
3. Interpret and apply appropriate procedures and criteria to conduct/perform code compliance activities on health products.
4. Apply prescribed procedures to conduct / perform vigilance and post marketing surveillance to ensure the safe use of health products.

Associated Assessment Criteria for Exit Level Outcome 1

ELO 1: Apply essential methods, procedures and techniques to submit applications pertaining to licences of healthcare establishments and registration of health products.

• Obtain the regulatory body's online registration processes, guidelines and forms for all health products to ensure strict adherence in the application processes.
• Obtain the regulatory body's licensing processes, guidelines and forms for all health establishments to ensure strict adherence to the licensing process.
• Perform due diligence on the file/s provided by a licence holder.
• Complete preparation of documentation for the various applications by giving due consideration to the regulatory body's validation (screening) and evaluation processes for health products.
• Complete all forms and supporting physical and electronic documentation required by regulator for the application through adherence to regulatory body's requirements.
• Utilise the regulatory body's electronic system or appropriate submission procedure/ mechanism to complete submission of dossiers for registration of a health product or licensing of a health establishment.

Associated Assessment Criteria for Exit Level Outcome 2

ELO 2: Apply essential methods, procedures and techniques to submit applications pertaining to renewals, amendments/ variations and retentions.

• Obtain the regulatory body's processes, guidelines and forms for renewals, amendments/variations and retention of all health products to ensure strict adherence to the application processes.
• Perform due diligence on the file/s provided by a licence holder.
• Complete all forms and supporting physical and electronic documentation required by regulator for the applications through adherence to regulatory body's requirements.
• Utilise the regulatory body's electronic system or appropriate submission procedure/mechanism to complete submission of applications for renewals, amendments/ variations and retentions.

Associated Assessment Criteria for Exit Level Outcome 3

ELO 3: Interpret and apply appropriate procedures and criteria to conduct/perform code compliance activities on health products.

• Check the contents and artwork of promotional and educational materials for a health product for compliance to relevant codes and standard operating procedures (SoPs).
• Check promotional activities for compliance with the relevant codes and SoPs and make recommendations for activities that do not comply.
• Complete checks and corrections to promotional and educational materials and activities and appropriately file/save and update administrative records as per regulatory requirements.
• Receive and lodge, escalate incoming and outgoing complaints pertaining to promotional and educational materials and activities, if required according to SoP.
• Handle and escalate unethical practices regarding promotional and educational materials and activities if required according to SoP.

Associated Assessment Criteria for Exit Level Outcome 4

ELO 4: Apply prescribed procedures to conduct / perform vigilance and post marketing surveillance to ensure the safe use of health products

• Explain concepts, definitions and terminology associated with vigilance.
• Complete and submit adverse reaction/event reporting form to the regulatory body in an assistive capacity through its appropriate submission procedure/mechanism.
• Implement a health product recall assignment in an assistive capacity according to standard operating procedures.
• Prepare a report on vigilance in an assistive capacity as per standard operating procedures.
• Prepare recall letters and media releases in an assistive capacity and sent to the industry, standard operating procedures.

Integrated Assessment

Integrated Formative Assessment

Formative assessments are conducted throughout the training of learners. A range of formal, nonformal, and informal ongoing assessment activities is used to focus on teaching and learning outcomes to improve learner attainment.

Formative assessments are conducted continuously by the facilitator to feed into further learning, to identify strengths and weakness, and to ensure the learner's ability to apply knowledge, skills and workplace experience gained.

Formative Assessments are conducted by the accredited Skills Development Provider (SDP), and a variety of ongoing assessment methods may be used, for example, quizzes, assignments, tests, scenarios, role play, interviews. Continuous feedback must be provided.

Integrated Summative Assessment

Integrated Assessment involves all the different types of assessment tasks required for a particular qualification, such as written assessment of theory and practical demonstration of competence. To achieve this, the Internal Assessment Criteria (IAC) for all modules as found in the QCTO curriculum document must be followed.

An accredited SDP should implement a well-designed, formal, relevant, final internal Summative Assessment strategy for all modules to prepare learners for the EISA. These assessments evaluate learning achievements relating to the achievement of each module of the relevant components of the qualification.

Internal Summative Assessments are developed, moderated, and conducted by the SDP at the end of each module or after integration of relevant modules, e.g., applied knowledge tests, workplace tasks, practical demonstrations, simulated tasks/demonstrations, projects, case studies, etc.