Quality Assurance in Supply Chain Management of Medicines 1 June- 29 June, 450 euros

Dear all, we are pleased to announce that registration is open for the following courses.
Please find detailed course programmes and registration instructions on
www.iplusacademy.org .

- Quality Assurance in Supply Chain Management of Medicines
1 June- 29 June, 450 euros,
http://www.iplusacademy.org/enrol/iplus/cmp.php?courseid=66

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.

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.

- Basic principles of SCM in for health systems ( MBA level)

15 June-27 July, 450 euros,
http://www.iplusacademy.org/course/view.php?id=69

Many of the issues of healthcare quality and safety are consequences of poor management of pharmaceuticals.
Globally it is estimated that an average 25% of the total health expenditure is on medicines,
with poorer countries spending as much as 30%.

Knowledge of the full supply chain cycle of pharmaceuticals and practical skills to enhance its performance are important,
not only for managers in leadership positions but for all health workers.
Supply chain management activities are fundamental to any health programme's performance and all personnel involved,
whether it's an inventory manager in a warehouse, a doctor in a health facility or a procurement officer at the central medical store,
must have a good understanding of the basic principles of managing health commodities.

This course is designed to introduce you to the basic concepts of supply chain management
with specific focus on pharmaceuticals and health commodities in a developing country context.
Whilst covering a broad range of topics, the course delivery will emphasize the importance of integrating supply chain activities for overall health system strengthening.

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

 Define the essential medicines concept and rational use of medicines.
 Describe the different steps and processes in the supply chain management of health commodities.
 Interpret and discuss the roles of managers and different stakeholders in supply chain management, within the overall health system.
 Be familiar with underlying principles of good storage and distribution practices of medicines.
 Underline the key issues surrounding monitoring and evaluation of supply chain management.
 Appreciate the importance and need for quality assurance of medicines along the supply chain.
 Understand and critically analyse supply chain systems in different countries to identify practical approaches and intervention strategies.

-  Good Manufacturing Practices and GMP Inspections for Medicines and Healthcare Products
1 June- 13 July, 450 euros, http://www.iplusacademy.org/enrol/iplus/cmp.php?courseid=68

The lack of a qualified human resources base in the manufacturing sector of medicines and other healthcare productst is a big challenge, especially in low and middle income countries.

In particular, there is need for skilled personnel for quality units (quality assurance, quality control) and other GMP relevant areas.
Costs for bringing in experts from abroad are high.

Combined with other challenges, local manufacturers often struggle to compete and even survive.
Not being in line with international quality standards, they are prevented from passing WHO prequalification, participating in international tenders, and entering international markets.

Moreover, the national medicines regulatory agencies (NMRAs) of these countries experience a shortage too of qualified staff in GMP, GMP inspection and dossier evaluation. This creates difficulties for the NMRAs to enforce internationally acceptable regulatory requirements (including GMP standards) thereby preventing the availability of affordable quality generics for the majority of their low income population groups.

This e-learning course introduces Good Manufacturing Practices and GMP inspections for medicines and healthcare products, focusing on WHO GMP standards and requirements as one of the major GMPs. Course participants will develop an understanding of the importance of implementing GMP in their daily working routine, starting from personnel hygiene to quality documentation and many other GMP requirements.

While the main focus in on medicines, an extra session of the course introduces the requirements for healthcare products, specifically female condoms. In the end, these capacity building measures in the area of GMP and GMP inspection will make the local manufacturing sector and the national regulatory authorities better equipped for production and regulation of quality assured essential medicines and healthcare products, in line with national and international standards.

After having successfully completed the course, participants will be able to:

  Appreciate the importance and need for good manufacturing practices.
  Be familiar with the development of medicines regulation.
  Understand the main requirements in GMP, including procedural, organizational and infrastructural aspects.
  Have gained basic information on requirements for healthcare products such as female condoms, as a special focus.
  Critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment.
  Understand the need for, and the benefit of GMP inspections.
  Be familiar with different types of GMP inspections.
  Interpret and discuss the role of GMP inspectors.
  Understand the inspection process and structure of an inspection report.

Carole Piriou
Senior training coordinator
i+solutions
Universal Access to Essential Medicines
phone: +31 0348 748 722
address: Polanerbaan 11, 3447 GN, Woerden, The Netherlands
email: cpiriou@iplussolutions.org
website: www.iplusacademy.org
Carole Piriou <CPiriou@iplussolutions.org