Quality Assurance in Supply Chain Management of Medicines

Course programme
Online course (ENQAS011) - July 2019

Introduction

Ensuring the quality of medicines is a major public health concern. The emergence of substandard and counterfeit medicines, coupled with inefficient supply chain systems, not only poses a risk of negative health outcomes but also leads to economic losses and lack of trust in the health system. To address these issues and develop evidence-based strategies, it is important that people at all levels, from policy makers to primary healthcare workers appreciate and comprehend the need for effective QA systems.

This course will introduce you to the concepts and main principles of quality assurance, and will develop further skills and knowledge in different aspects of quality assurance such as pharmaceutical regulation, pharmacovigilance and quality control of medicines.

Course objectives

After having successfully completed the module, students will be able to:

  • Define the key concepts and principles of quality assurance.
  • Comprehend the importance of quality assurance systems for medicines.
  • Describe how different functions of supply chain management affect the quality of medicines.
  • Explain the significance of shelf life and differentiate between types of stability studies.
  • Underline the key issues and challenges surrounding quality assurance systems especially in low and middle income countries.

Target participant group

The course is designed for personnel working in health programmes, health organisations, or national health systems who have an interest in, and will benefit from knowing more about quality assurance of medicines (procurement offices, supply and logistics divisions, regulatory bodies, hospitals, health facilities). There are no specific prerequisites for enrolling in this course. However, prior knowledge about supply chain management or pharmaceuticals will be an advantage.

Teaching and learning strategy

The course is taught online on i+academy, a Moodle e-learning platform, accessible from anywhere at any time. The interactive course materials are presented sequentially under the guidance of expert facilitators from i+solutions who assist the participants during their learning progress, answer questions and stimulate interactions. Lessons are complemented and enlivened by online activities such as discussion forums, quizzes, and assignments.

Assessment and grading

Participants will be graded based on their online participation and their performance. A certificate of completion and an e-badge will be awarded to all those who complete a minimum of 75% of all online activities (lessons, quizzes, discussion forums) AND attain a grade of at least 7/10 on the end-of-course quiz. The percentage of completion will be measured automatically online as the participant goes through the course. The grade of the end-of-course quiz will also be determined automatically, there are an unlimited number of attempts allowed. In addition, there are several non-graded activities such as short assignments and short quizzes to guide the learning process of the participants.

Course duration

4 weeks

Start date: Monday, 29 July 2019 13:00 (UTC)

End date: Monday, 26 August 2019 13:00 (UTC)

Level of effort: 4 hours per week

Course schedule


Week 1 Importance of quality assurance
Medicines regulation
Week 2 Ensuring quality in the manufacturing process
Ensuring quality of medicines during procurement
Week 3 Ensuring quality along the supply chain
Medicines quality control testing
Week 4 Stability studies and shelf life determination
Pharmacovigilance
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