Description
COURSE OVERVIEW
Pharmaceutical industry provides a valuable contribution to society, but at the same time it is a business whose profits are directly dependent on marketing and promotion as key factors for sales volumes. Health care and welfare of patients should be top priority for any pharmaceutical company. Pharmaceutical products are in categories of social goods and they have specific ethical, regulatory and commercial positions as health care products, and not just as durable consumer goods. Pharmaceutical companies must meet high standards of quality, safety and efficacy, as determined by the regulatory authorities and shall at all times be ethical and professional. Codes of industrial pharmaceutical practices are the foundation for regulating the promotion of drugs and therefore play an important role in the relations between enterprises and other stakeholders in the provision of health care.
COURSE OBJECTIVE(S)
The objectives of this course are to:
- To expose students to some of the regulations governing pharmaceutical operations
- To introduce students to the ethical issues in pharmaceutical supply chain operations.
- To discuss the key national and international regulatory frameworks and bodies in pharmaceutical operations.
- To highlight the key pharmaceutical supply chain operational challenges and remedies.
- To assist students, understand the governance issues and good manufacturing practices in pharmaceutical business operations.
- To expose students to the regulatory requirements on good manufacturing practices for pharmaceuticals
LEARNING OUTCOMES
On completion of the pharmaceutical business regulations, ethics and challenges course, the students should be able to:
- Outline the key principles of good regulatory practices for pharmaceuticals
- Outline the framework for the regulation of pharmaceuticals
- Discuss the operational challenges in pharmaceutical business
- Explain the regulatory requirement for good manufacturing practices
- Outline the codes of professional conduct for pharmaceutical supply chain professionals
- Outline the ethical and ethical pharmaceutical business promotion issues
- Explain the need for the global harmonization of pharmaceutical regulations
- Recognize key factors that promotes good regulatory practices
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