Skills Development in Post Market Surveilance
Code
UC17_MC
Department
Cardiopneumology teaching area of ESSCVP
Credits
14
Teacher in charge
Nuno Miguel Ferreira Raposo
Teaching language
Portuguese / English
Objectives
It is intended for students to develop advanced theoretical and theoretical-practical skills, which will be the basis for their project work or internship. 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 a project work or a clinical specialization internship.
Therefore, the main skills to acquire in the area of Supply Chain Management and After Sale Follow-up are:
1. To acquire theoretical knowledge about key concepts as Supply Chain and After Sale Follow-up;
2. To acquire 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 all normative references required;
4. To design a project work or internship report.
Prerequisites
This is exclusive of UC respective area of expertise. Given the nature of the school and being that students are placed in different locations of clinical practice or business, these classes are taught individually to each student. The number of professors (tutors) depends on the number of vacancies for each area of expertise.
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. Technician responsible in companies of the medical devices sector;
8. Other key functions: Head of Logistics and Head of Customer Service;
9. Management of complaints;
10. Management of Field Safety and Recall;
11. The Manual of Good Practices on Distribution and Storage (MGPDS) in the sector of medical devices: its design, implementation and maintenance;
12. Periodic self-inspection and audit in the area MGPDS;
13. Design study/project/internship report within Supply Chain Management and After Sale Follow-up.
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 teaching methodology used is the Tutorial Guidance and Fieldwork. In this methodology, students will be supervised by one teacher, responsible to guide them while they are studying the constant subjects from the syllabuses, indicating sources of information and establishing a work plan. Students will also be asked to develop a set of detailed works to present to the teacher. The stage of acquisition and reinforcement of knowledge will be complemented with internships in companies of the medical devices sector, where students will have the opportunity to initiate the practice within the chosen specialty.
Simultaneously, it will take place the process of choosing the subject for the project work or internship, whose design will be developed by the student.
Evaluation method
The evaluation will consist of the works where students should expand their knowledge and for the study design.
Courses
