Drug Safety and Risk Management

Code: CMS14711O

3 ECTS

Duration: 15 weeks/78 hours

Scientific Area: Ciências Farmacêuticas

Teaching languages: Portuguese

Languages of tutoring support: Portuguese

Presentation

It will address one of the most important areas in terms of the development and use of medicines, the best known face being Pharmacovigilance. Whether in the clinical trial stages or after market introduction, the objective of this course is a global introduction to the topic and its application.

Sustainable Development Goals

3. Saúde de qualidade - Assegurar uma vida saudável e promover o bem-estar para todos, em todas as idades.

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

12. Produção e consumo sustentáveis - Assegurar padrões de produção e de consumo sustentáveis.

16. Paz, justiça e instituições eficazes - Paz, justiça e instituições eficazes promover sociedades pacíficas e inclusivas par ao desenvolvimento sustentável, proporcionar o acesso à justiça para todos e construir instituições eficazes, responsáveis
e inclusivas em todos os níveis.

Learning Goals

The main objective of this course is to introduce the topic of risk management and drug safety globally, as well as to integrate knowledge in its main dimensions, specifically:
i) Introduction to pharmacovigilance.
ii) National Pharmacovigilance System.
iii) European and Global Pharmacovigilance System.
iv) Regulatory aspects.
v) Spontaneous reporting of adverse drug reactions.
vi) Evaluation of the safety of the drug.
vii) Pharmacovigilance research methodologies and databases.
viii) Periodic safety reports.
ix) Risk management plans and measures.
x) Artificial intelligence and machine-learning in pharmacovigilance: potentialities and challenges.

i) Introduction to pharmacovigilance.
ii) National Pharmacovigilance System.
iii) European and Global Pharmacovigilance System.
iv) Regulatory aspects.
v) Spontaneous reporting of adverse drug reactions.
vi) Evaluation of the safety of the drug.
vii) Pharmacovigilance research methodologies and databases.
viii) Periodic safety reports.
ix) Risk management plans and measures.
x) Artificial intelligence and machine-learning in pharmacovigilance: potentialities and challenges.

Teaching Methods

Classes take place in the form of seminars, in face-to-face sessions (12h). They will be essentially expository and constructivist, since the trainees will be an active part of the learning and dynamics of the sessions.
The classes also have the participation of external specialists invited and/or indicated by INFARMED, I.P..

Assessment

The evaluation will be quantitative and carried out at the end of the course, integrating the result of the face-to-face sessions and the students' autonomous work. This evaluation will take place remotely, asynchronously. Both the evaluation and teaching methodology will be dynamic and motivating for students adherence and involvement.