Code: | MI074163 | Acronym: | DSPMED |
Keywords | |
---|---|
Classification | Keyword |
OFICIAL | Health Sciences |
Active? | Yes |
Responsible unit: | Pharmaceutical Technology Laboratory |
Course/CS Responsible: | MSc in Pharmaceutical Sciences |
Acronym | No. of Students | Study Plan | Curricular Years | Credits UCN | Credits ECTS | Contact hours | Total Time |
---|---|---|---|---|---|---|---|
MICF | 54 | MICF - Transition Study Plan 2023/24 | 3 | - | 3 | 52 | 81 |
To provide students with technical, scientific and regulatory knowledge underlying Medical Devices and In Vitro Diagnostic Medical Devices, in order to provide them the necessary scientific bases and professional skills, namely in manufacturing, quality control, placing on the market/regulatory affairs, wholesale distribution, selection, acquisition, storage, counseling and dispensing.
Learning outcomes:
In the end, the student should master the technical, scientific and regulatory aspects inherent to Medical Devices and In Vitro Diagnostic Medical Devices.
Skills:
In the end, the student should have developed general and specific skills in the fields of Medical Devices and In Vitro Medical Devices, namely in manufacturing, quality control, placing on the market/regulatory affairs, wholesale distribution, selection, acquisition, storage, counseling and dispensing.
The syllabus of the Curricular Unit was designed on the assumption that students have knowledge on Anatomy, Histology, Physiology, Biochemistry, Pharmaceutical Chemistry, Microbiology, Pharmacology, Immunology, Pharmaceutical Technology, Pathophysiology and Pharmacotherapy.
1) Introduction
1.1) Definitions and concepts
1.1.1) Medical Device
1.1.1.1) Active Medical Device
1.1.1.2) Nonactive Medical Device
1.1.1.3) Custom-made Medical Device
1.1.1.4) Experimental Medical Device
1.1.1.5) Procedure Packs of Medical Devices
1.1.2) “In Vitro” Diagnostic Medical Devices
1.2) Classification of Medical Devices based on the inherent potential hazard level
1.2.1) Risk classes
1.2.2) Fundamentals of classification and application criteria
1.2.3) Practical implications of the classification of the Medical Devices
1.3) Classification of “in vitro” Diagnostic Medical Devices based on the inherent potential hazard level
1.3.1) Fundamentals of classification and application criteria
1.3.2) Practical implications of the classification of “In Vitro” Diagnostic Medical Devices
2) European regulatory frameworks of Medical Devices and “In Vitro” Diagnostic Medical Devices
2.1) Placing on the market
2.2) Conformity assessment
2.3) Competent Authority and its functions
2.4) Notified Body and its functions
2.5) CE marking
2.6) EU declaration of conformity and EU certificate of conformity
2.7) Labelling and leaflet/instructions manual. Harmonized symbols.
2.8) Vigilance
2.9) Recall and discard of Medical Devices and “In Vitro” Diagnostic Medical Devices
3) Study of the most common devices in Community and Hospital Pharmacy
3.1) Dressing material
3.2) Devices for ostomy
3.3) Devices for urinary incontinence
3.4) Devices for Orthopedics
3.5) Sutures
3.6) Devices for drainage, irrigation and dilatation
3.7) Devices for compression therapy
3.8) Devices for measuring blood pressure
3.9) “In vitro” Diagnostic Medical Devices for self-testing (glycemia, glycosuria, ketonuria, cholesterol, plasma triglycerides, pregnancy, COVID-19)
3.10) Others “In vitro” Diagnostic Medical Devices for self-testing
Theoretical classes: 2 x 50 minutes / week.
Practical / Laboratory classes: 2 hours / week. Aimed at the planning and execution of laboratory tests and performing exercises.
In addition to the established schedules for classes, the professor is available to meet students at any time previously agreed.
designation | Weight (%) |
---|---|
Exame | 70,00 |
Trabalho laboratorial | 30,00 |
Total: | 100,00 |
designation | Time (hours) |
---|---|
Estudo autónomo | 45,00 |
Frequência das aulas | 45,00 |
Trabalho de campo | 10,00 |
Total: | 100,00 |
The attendance to practical / laboratory classes is a prerequisite for obtaining frequency and, therefore, for the admission of the students to the final exam of the Unit.
According to the FFUP Student Assessment Standards, the student fulfills the attendance requirements if the number of absences to practical / laboratory classes not exceed 25% of scheduled classes.
In the theoretical classes it is not compulsory to comply with attendance.
COMPONENTS OF THE EVALUATION:
DISTRIBUTED COMPONENT (0-20) – valued on the basis of the works presented by students at the practical / laboratory classes along the term (30%);
FINAL EXAM (0-20) – written exam that focuses on all matters actually taught in lectures and practical / laboratory classes along the term (70%).
Students with a score equal to or higher than 9.5 (0-20) in the final exam are considered approved.
Students with a score less than 9.5 (0-20) in the final exam are considered failed.
FINAL SCORE CALCULATION (0-20):
Final Exam Score x 0.7 + Distributed Component Score x 0.3
In accordance to the FFUP Student Assessment Standards and the applicable legislation.
In accordance to the FFUP Student Assessment Standards.