Health Sciences and Social Services Curative Health

Ethical and Legal Compliance in Pharmaceutical Environments Training

SAQA US 256485 | NQF 3 | Credits 8 | Duration 5 Days
From $913 per delegate

Description

This course equips learners with the knowledge and skills to apply ethical principles and legal requirements in pharmaceutical and health environments. It ensures that participants can identify and manage ethical dilemmas, comply with relevant legislation, and promote integrity in their professional roles.

Learning Outcomes

  • Apply ethical principles and codes of conduct in pharmaceutical and health settings.
  • Analyze legal and regulatory frameworks governing pharmaceutical practice in South Africa.
  • Evaluate ethical dilemmas and propose compliant solutions.
  • Implement procedures to ensure confidentiality and data protection.
  • Demonstrate professional conduct in accordance with the South African Pharmacy Council (SAPC) standards.
  • Design strategies to promote ethical culture and legal compliance within a team.

Target Audience

This course is designed for pharmacists, pharmacy assistants, pharmaceutical sales representatives, and healthcare professionals who work in or interact with pharmaceutical environments and need to ensure ethical and legal compliance.

Prerequisites

None — open enrollment

Course Outline

Day 1: Foundations of Ethical and Legal Compliance in Pharmaceuticals

Objectives:
• Understand the regulatory framework governing pharmaceutical environments in South Africa.
• Define key ethical principles and their application to pharmaceutical practice.
• Identify the legal consequences of non-compliance in the pharmaceutical sector.
• Recognise the roles of SAHPRA and other regulatory bodies.
• Explain the relationship between ethics, law, and professional conduct.

Topics:
• Overview of pharmaceutical regulatory environment in South Africa.
• Introduction to key legislation: Medicines Act, Pharmacy Act, and related regulations.
• Core ethical principles: autonomy, beneficence, non-maleficence, justice.
• Professional codes of conduct for pharmacists and pharmaceutical personnel.
• Roles and responsibilities of SAHPRA and professional councils.
• Consequences of non-compliance: legal, professional, and reputational.
• Case study: Ethical dilemmas in pharmaceutical practice.

Day 2: Legal Frameworks and Regulatory Requirements

Objectives:
• Distinguish between different types of pharmaceutical legislation and their scope.
• Describe the requirements for licensing, registration, and inspection.
• Apply legal requirements for record-keeping and documentation.
• Understand the legal implications of dispensing, manufacturing, and distribution.
• Analyse case studies involving legal compliance issues.

Topics:
• Detailed review of the Medicines and Related Substances Act.
• Pharmacy Act and regulations for pharmacy practice.
• Good Pharmacy Practice (GPP) standards and guidelines.
• Licensing and registration of premises and personnel.
• Legal requirements for prescription handling and record-keeping.
• Regulatory requirements for manufacturing and distribution.
• Inspections and audits: preparation and response.
• Case study: Legal pitfalls in pharmaceutical operations.

Day 3: Ethical Decision-Making and Professional Conduct

Objectives:
• Apply ethical decision-making frameworks to complex pharmaceutical scenarios.
• Evaluate the role of ethics committees and ethical review processes.
• Demonstrate understanding of patient rights and confidentiality.
• Identify conflicts of interest and strategies to manage them.
• Develop a personal ethical framework for professional practice.

Topics:
• Ethical decision-making models: principle-based, consequentialist, virtue ethics.
• Patient rights and informed consent in pharmaceutical care.
• Confidentiality and data protection under POPIA.
• Managing conflicts of interest: gifts, incentives, and relationships.
• Ethical issues in clinical trials and research.
• Role of ethics committees and institutional review boards.
• Professional boundaries and ethical responsibilities.
• Case study: Resolving ethical conflicts.

Day 4: Compliance Management and Risk Mitigation

Objectives:
• Implement compliance management systems in pharmaceutical settings.
• Conduct risk assessments related to ethical and legal compliance.
• Develop policies and procedures to ensure ongoing compliance.
• Understand the role of internal audits and corrective actions.
• Evaluate compliance through key performance indicators.

Topics:
• Components of an effective compliance management system.
• Risk identification and assessment in pharmaceutical operations.
• Developing and implementing compliance policies and SOPs.
• Internal auditing: planning, execution, and reporting.
• Corrective and preventive actions (CAPA) for non-compliance.
• Training and communication for compliance culture.
• Monitoring and measuring compliance performance.
• Case study: Building a compliance framework.

Day 5: Integration, Case Studies, and Continuous Improvement

Objectives:
• Synthesise knowledge from previous days to solve complex compliance challenges.
• Critique real-world case studies of ethical and legal failures.
• Develop a personal action plan for ethical and legal compliance.
• Demonstrate ability to advise on compliance matters.
• Understand the importance of continuous professional development in compliance.

Topics:
• Comprehensive case study: Multi-faceted ethical and legal dilemma.
• Lessons from pharmaceutical scandals and regulatory actions.
• Whistleblowing and reporting mechanisms.
• Continuous improvement in ethical and legal compliance.
• Developing a personal compliance toolkit.
• Role-play: Advising a colleague on an ethical issue.
• Future trends in pharmaceutical regulation and ethics.
• Course review and assessment.

Practicals

No practicals for this training.

This course is made up of exercises and case studies delivered alongside the theory — no separate practical sessions are required to complete it.

Summatives

Each delegate is assessed continuously throughout the course and a final summative test at the end.

Daily Exercises — 30%

Every training day ends with a multiple-choice exercise scored out of 100%. The scores from each daily exercise are averaged across the duration of the course to produce a Daily Average mark, which contributes 30% to the final total.

Final Test — 70%

On the last day a final summative test is written. It is a multiple-choice paper with multiple-answer questions: each question may have more than one correct option, and a single wrong selection on a question marks the entire question wrong — no partial credit. The final test is scored out of 100% and contributes 70% to the overall mark.

Final Total
Component Out of Weight
Daily Average (multiple choice) 100% 30%
Final Test (multi-answer multiple choice) 100% 70%
Final Total 100%

All marks are recorded on the AATICD LMS and visible to each learner under their account.

Certificate

Certificate of Completion

Awarded to delegates who achieve an overall mark of 50% or higher on the Final Total (Daily Average 30% + Final Test 70%).

How it works
  • Certificates are auto-generated on the AATICD LMS as soon as the marks pass the 50% threshold.
  • Each certificate is a branded PDF with the delegate's name, the course title, the unit standard ID, NQF level, credits, and the date of issue.
  • You can download or print your certificate from your LMS dashboard at any time after issue — there's no reissue fee and no expiry date.
  • If you scored under 50% you can sit the final test again at the next scheduled session at no extra cost.
Where to find it

Sign in to the LMS, open your dashboard, and your certificates appear under My Certificates. Each entry has a View / Download button and a print option.

Training Discounts

Group discounts apply automatically — the more delegates you enrol, the greater the saving. Discounts are calculated at 3% per 5 delegates, scaling up to 40% off for 100+ delegates.

Delegates Discount
5 3% off
10 6% off
15 9% off
20 12% off
25 15% off
30 18% off
50 30% off
75 35% off
100 40% off

3% discount per 5 delegates, up to 40% off for 100+ delegates. Contact us for a custom group quote.

Upcoming Training Sessions
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Training Discounts
Delegates Discount
5 3% off
10 6% off
15 9% off
20 12% off
25 15% off
30 18% off
50 30% off
75 35% off
100 40% off

3% off per 5 delegates, up to 40% for 100+

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