Clinical Research Studies & Evidence-Based Medicine
Learning Outcomes
By the end of this course, learners will be able to:
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Explain the purpose and principles of clinical studies to demonstrate the effective, safe, and appropriate use of health products.
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Describe the contexts in which clinical studies are conducted.
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Identify and explain appropriate methods for analysing clinical study results.
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Apply selected analysis methods to interpret clinical study results.
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Design a fair and ethical strategy that highlights the advantages of a product based on analysed study outcomes.
Course Content
Module 1: Principles of clinical research methodology
Module 2: Evidence-based medicine
Module 3: Interpretation of clinical study results and reports
Module 4: Accurate and ethical paraphrasing of clinical study results
Special Features
The following are included:
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Test yourself quizzes along the way to cement your learning and build confidence
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Certificate of completion on achievement of 80% of the knowledge questionnaire
Pharmacology
Learning Outcomes
By the end of this course, learners will be able to:
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Describe the absorption, distribution, metabolism, and excretion of medicines in the human body (pharmacokinetics). Effects include but are not limited to the therapeutic, undesired and adverse effects.
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Describe the effects of medicines on the systems and organs of the body (pharmacodynamics).
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Describe the therapeutic classification of medications is described to match action with treatment objectives. Officially recognised systems of therapeutic classification are utilised.
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Describe the interactions and the safety of medicines in accordance with current regulatory requirements and available information.
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Describe the methods utilised to ensure effective pharmaceutical products supply and storage are described in terms of product integrity, including relevant regulation, schedules, quality assurance, documentary requirements and storage.
Course Content
Module 1: Pharmacokinetics and Pharmacodynamics
Module 2: Influence of pharmacuetics and the effects of medicine in the body
Module 3: Safety of medicines in patient care and pharmacovigilance
Module 4: Relevant current pharmaceutical and health legislation
Module 5: Patient information leaflets and package inserts
Module 6: Relevant current information systems and resources
Special Features
The following are included:
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Test yourself quizzes along the way to cement your learning and build confidence
-
Certificate of completion on achievement of 80% of the knowledge questionnaire
Pharmacovigilance
Learning Outcomes
By the end of this course, learners will be able to:
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Implementation of pharmacovigilance principles is explained and identified
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Describe the actions to be taken in the event of a medicine recall to ensure effective communication and implementation are explained.
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Implications of non-compliance with pharmacovigilance requirements are understood
Course Content
Module 1: Concept, definitions and terminology
Module 2: Global practice and requirements
Module 3: Accountability and responsibilities
Module 4: Complaints and recalls
Module 5: Noting the safety of drugs
Module 6: The role of the responsible pharmacist and/or regulatory officer
Special Features
The following are included:
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Test yourself quizzes along the way to cement your learning and build confidence
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Certificate of completion on achievement of 80% of the knowledge questionnaire
Responsible Pharmacists
Learning Outcomes
By the end of this course learners will be able to:
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Explain the core concepts and principles of management within the pharmacy environment.
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Interpret and apply key legislation relevant to pharmacy practice and the role of the Responsible Pharmacist (RP).
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Provide guidance on human resource practices in line with labour and pharmacy legislation.
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Implement the responsibilities of the RP in accordance with Good Pharmacy Practice (GPP).
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Apply quality assurance principles to ensure safe and effective pharmacy operations.
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Oversee daily pharmacy operations in compliance with legal and professional standards.
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Prepare for and conduct SAPC and SAHPRA inspections effectively.
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Ensure compliance with medicines legislation, including pricing controls, discounting, bonusing, and sampling.
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Monitor and evaluate pharmacy processes to ensure adherence to professional and ethical standards.
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Lead the pharmacy team in fostering a culture of compliance, accountability, and continuous improvement.
Course Content
Module 1: Basic principles of management
Module 2: Regulatory
environment
Module 3: Human Resources
Module 4: Responsibilities of the RP
Module 5: The RP and
quality assurance
Module 6: The RP and pharmacy operations
Module 7: Performing a
self-inspection
Special Features
The following are included:
-
Test yourself quizzes along the way to cement your learning and build confidence
-
Certificate of completion on achievement of 80% of the knowledge questionnaire
