NOVA Medical School | Faculdade de Ciências Médicas

Supply Chain Management and PMS

Code

UC9_MC

Department

Cardiopneumology teaching area of ESSCVP

Credits

4

Teacher in charge

Marco Maria Francesco Bottazzi

Teaching language

Portuguese / English

Objectives

It is intended for students to develop basic theoretical and theoretical-practical skills. The main objective of this course is to prepare students through detailed theoretical basis, complementary to the ones acquired in the degree course, in order to develop advanced skills in this area.

Therefore, the main skills to acquire in the area of Supply Chain Management and After Sale Follow-up are:

1. To acquire basic theoretical knowledge about key concepts on Supply Chain and After Sale Follow-up;

2. To acquire basic theoretical knowledge in the area of implementation and Monitoring of the Manual of Good Practice for Storage and Distribution of Medical Devices;

3. To identify, in general, the normative references required;

4. To know the general principles of pharmacovigilance systems.

Prerequisites

None.

Subject matter

1. Advanced concepts of product and product/service;

2. Advanced concepts of supply chain;

3. The supply chain in the medical devices sector: advanced concepts;

4. Advanced concepts of after sales follow-up;

5. The after sales follow-up in the medical devices sector: advanced concepts;

6. Regulatory/legal framework for the medical devices sector;

7. Business functions involved in the Distribution and After Sales Follow-up in the area of Medical Devices;

8. Management of complaints;

9. Management of Field Safety and Recall;

10. The Manual of Good Practices on Distribution and Storage (MGPDS) in the sector of medical devices: its design, implementation and maintenance;

11. Periodic self-inspection and audit in the area MGPDS;

12. General concepts of Pharmacovigilance.

Bibliography

• Martin Christopher - Logistic and Supply Chain Management (3rd Edition), Prentice Hall (2005)

• José Crespo de Carvalho - A Lógica da Logística (1a Edição), Edições Sílabo (2004)

• Philip Kotler - Marketing Management, Prentice Hall (2003)

• Decreto-Lei nº 145/2009 de 17 de Junho - "Estatuto do Dispositivo Médico"

• Portaria nº 348/98 de 15 de Junho - "Boas Práticas de distribuição de medicamentos de uso humano e de medicamentos veterinarios"

• Decreto-Lei nº 6/2009 de 6 de Janeiro - "Regime de recolha, tratamento, reciclagem e eliminação dos residuos de pilhas e acumuladores"

• Decreto-Lei nº 178/2006 de 5 de Setembro - "Regime geral de gestão de residuos"

• Decreto-Lei nº 230/2004 de 10 de Dezembro - "Regime juridico a que fica sujeita a gestão de residuos de equipamentos electricos e electronicos (REEE)"

• Guidance Document - MEDDEV 2.12-1 ver.6

Várias Páginas da Internet

Teaching method

The methodology consists on theoretical and theoretical-practical classes, including exercises and case studies analysis. In this methodology, students will be supervised by one teacher, which will be responsible for teaching the subjects included in the syllabus, according to the plan previously designed. Students will also be asked to develop a set of detailed works to present to the teacher, in a variable number according to the subjects.

Evaluation method

The evaluation will consist of exercises and analysis of case studies developed in classes and by several works to reinforce their knowledge – at least two.

Courses