Market Introduction Processes

Code: CMS14609O

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

This curricular unit addresses the different phases and procedures of the registration and marketing authorisation processes for medicines and medical devices, including borderline products.

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 main objective of the curricular unit is to carry out a regulatory and procedural approach to the processes of market introduction of medicines and medical devices, as well as the borderline cases between them. Students should acquire knowledge and skills in terms of the different phases and procedures of the registration and authorization processes for medicines and medical devices. They should also be able to identify borderline cases, as well as analyze them and understand the differences between different examples.

1. PT and EU regulatory framework: medicines and medical devices.
2. National and European authorities.
3. Medicines for human use:
a. Marketing Authorization Procedures (MA) EU and PT.
b. MA file (common technical document).
c. Modification and revocation of the MA file.
d. Adaptive pathways.
e. Priority medicines (PRIority MEDIcines, PRIME programme).
f. Generic and biosimilar medicines.
4. Medical devices:
a. Definition, classification, and demarcation of borders.
b. Competent authority notified body and associations.
c. CE marking.
d. Essential requirements and harmonized standards.
e. Supporting technical documentation.
f. Compliance assessment.
g. Conformity declaration.
h. Registration, encoding, traceability and unique identification.
5. Common points/different

Teaching Methods

Classes take place in face-to-face sessions (9h): divided into three classes inaugural, workshop and evaluation; the rest (21h) being carried out remotely. The teaching methodology will be centered on dynamic learning based on the presentation of fundamental concepts, followed by theoretical-practical sessions of work discussion involving: a) discussion and critical analysis of scientific articles; b) simulation of practical cases. The features of Moodle, videos and other synchronous and asynchronous methodologies considered adequate to the pedagogical objectives of the curricular unit will be used.

Assessment

The final assessment results from the continuous assessment of the work developed/presented/discussed throughout the course (40%) and a final written work (60%).