Introduction to the Medicine and Medical Devices Life Cycles

Code: CMS14598O

3 ECTS

Duration: 15 weeks/78 hours

Scientific Area: Ciências Farmacêuticas

Teaching languages: Portuguese

Languages of tutoring support: Portuguese, English

Regime de Frequência: E-learning

Presentation

Curriculum unit that aims to provide students with a general introduction to the life cycles of the medicines and medical device that will enable them to understand the various aspects to be studied in greater detail throughout the postgraduate or short courses

Sustainable Development Goals

4. Educação de qualidade - Assegurar a educação inclusiva, e equitativa e de qualidade, e promover oportunidades de aprendizagem ao longo da vida para todos.

Learning Goals

The purpose of this curricular unit is to provide students with an overview of the medicines and medical devices life cycles that will allow them to understand the various aspects to be studied in greater detail throughout the post-graduation or short courses. At the end of the course unit students are expected to be able to identify and describe the similarities and differences between the life cycles of medicines and medical devices, to know what they are, how they are defined and to give examples of these two categories. Students should also learn about the various relevant authorities, institutions and bodies throughout the life cycle of medicines and medical device

1. General approach to medicines and medical device life cycles: the steps, regulation and regulators;
2. Medicines:
a. Concept of drug and medicine;
b. How they are classified;
c. Who participates in the life cycle of the medicine;
d. Market data;
e. Regulatory sources;
f. International, European and national authorities;
3. Medical device:
a. What is a medical device;
b. How they are classified;
c. Who participates in the life cycle of the medical device;
d. Market data;
e. Regulatory sources;
f. International, European and national authorities.
4. Workshop: Differences and similarities between medicines and medical devices throughout their life cycles

Teaching Methods

Classes will be held in face-to-face sessions (9H); divided into lectures, assessment and workshop; the remaining (21H) being done at a distance. The teaching methodology will be centered on dynamic learning based on the presentation of fundamental concepts followed by discussion and debate of ideas. Will be used Moodle features, videos and other synchronous and asynchronous methodologies considered appropriate to the pedagogical objectives of the course. Two personalities in this area will be invited to the Workshop, which will be a fundamental aspect for student learning.