Scientific and Technical Assessment

Code: CMS14611O

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

Scientific and technical assessment of medicines and medical devices, as well as frontier products. Regulatory, ethical and methodological aspects underlying each of the different stages of assessment.

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 course is to approach all stages of scientific and technical assessment of medicines and medical devices, with an emphasis on clinical studies and their regulatory, ethical, and methodological aspects. Students should clearly distinguish the evaluation processes of medicines and medical devices, as well as identify and characterize frontier products and their specificities.

1. Preclinical and clinical trials:
a. Historical aspects.
b. Ethical aspects.
c. Classification.
d. Operationalization.
e. National and European regulations (incl. ICH).
f. Stakeholders (researcher, sponsor, trial sites, CRO's, competent authorities, CEIC).
2. Scientific and technical assessment of medicines:
g. Pre-clinical evaluation: pre-clinical trials.
h. Clinical evaluation: clinical trials.
i. Bioavailability/bioequivalence assessment.
j. Pharmaceutical evaluation: quality tests of the active substance, formulation and packaging.
3. Clinical assessment of medical devices:
k. Pre-clinical evaluation: pre-clinical trials.
l. Clinical assessment based on clinical data.
m. Functional assessment: in vitro diagnostic medical devices.
4. Common points/differentiation.

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 exam (60%).