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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Competency Standards in South Africa

Competency Standards for a Specialist Pharmacist who provides Industrial Pharmaceutical services in South Africa

Table 1: Summary of Industrial Pharmacy domains and competencies

Domain 6: Research and Development

 

DOMAIN 6: RESEARCH AND DEVELOPMENT

 

INTRODUCTION

 

Research and development are essential for the initial development of medicines and medical devices and are required throughout a lifetime to maintain control of diseases and establish the treatment of newly discovered diseases. The domain includes behavioural statements relating to research and development in an industrial pharmacy setting. The competencies required in the domain are:

 

6.1 Research technologies relevant to improving industrial pharmaceutical services.

 

6.2 Development of dosage forms.

 

6.3 Management of clinical trials.

 

DOMAIN 6: EDUCATION, TRAINING AND RESEARCH

COMPETENCIES

BEHAVIOURAL STATEMENTS
6.1 Research technologies relevant to improving industrial pharmaceutical services.
6.1.1 Demonstrating a detailed knowledge and understanding of the development of new medicines and medical devices.
6.1.2 Demonstrate the ability to discover new APIs for the development of medicines.
6.1.3 Demonstrate the ability to research new methods of manufacturing, distribution, and dossier development.
6.1.4 Publish articles on research findings.
6.1.5 Develop, implement and maintain the record for training and assessment of healthcare teams, patients and the public.
6.1.6 Demonstrate the ability to provide pharmaceutical advice on specialised nutrition support or any other similar products.
6.1.7 Design and evaluate health technology assessments.
6.2 Formulation and development of dosage forms.
6.2.1 Demonstrate the ability to conduct research and develop formulations for various dosage forms.
6.2.2 Assess the performance and stability of newly developed formulations of dosage forms.
6.2.3 Ensure that the relevant documentation relating to the development of the formulations complies with the applicable standards.
6.2.4 Demonstrate the ability to provide advice regarding the formulation of dosage forms.
6.3 Management of clinical trials
6.3.1 Participate in the development and evaluation of clinical trial protocols in all phases.
6.3.2 Ensure that prior approval is obtained from relevant statutory bodies.
6.3.3 Develop a process to prepare a clinical trial master file and all required documents.
6.3.4 Implement and monitor all the relevant aspects of the clinical trial protocols throughout the respective studies.