Development of Medicines and Medical Devices

Code: CMS14602O

3 ECTS

Duration: 15 weeks/78 hours

Scientific Area: Ciências Farmacêuticas

Teaching languages: Portuguese

Languages of tutoring support: Portuguese

Presentation

Curriculum unit that aims to provide an overview of the main methodologies used for the development of medicines and medical devices

Sustainable Development Goals

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

This curricular unit is intended to provide students with an overview of the main methodologies used for the development of medicines and medical devices. In the first case it is particular objective to get to know the development of new molecules and drugs, from the laboratory bench. In medical devices, the objectives are the knowledge of how they are created and developed based on good practices. At the end of the course unit the student is expected to be able to identify and describe the similarities and differences between the methodologies for drug development and medical devices. Students should also acquire competences in the implementation of good practices and procedures for industrial and innovation protection.

1. Development of medicines:
a. Discovery of new drugs;
b. Design;
c. Development of new molecules with therapeutic potential;
d. Development of biopharmaceuticals
e. Patents;
2. Development of medical devices:
a. Design and value engineering;
b. Manufacturing, assembly, packaging and testing of combination products;
c. Good manufacturing practices for medical devices (ISO 13485).
3. Workshop: common ground/differentiation.

Teaching Methods

Classes take place in face-to-face sessions (9H); divided into two classes, 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 unit. Representatives from Apifarma and Apormed will be invited to participate in the Workshop and other moments of the curricular unit.

Assessment

Students will be continuously assessed where they will have to present a case study on the development of a medicine and a medical device (50%), work to be carried out in groups of up to 2 students, and two individual assignments (monograph of up to 10 pages and oral presentation) on a topic of interest to the student (50%).