Pharmacovigilance

Solid knowledge of the contents contained in the disciplines of Pharmacology I and II and Pharmacotherapy I and II.
General knowledge about Pharmacokinetics and Pharmacodynamics.

M1. The learning process value the skills of learning and the collaborative work. From the bibliographic support
recommended, students will integrate the knowledge trough working groups and holistic analyses of practical cases to
report in the classroom. The teacher acts as a facilitator of learning process.
M2. The learning will be done through the study of theory, analysis and discussion of practical cases. The theoretical
component uses the expository method, in a student-centered learning context.
M3. Working groups, with collaborative knowledge dissemination tools, being their commitment and relation with these
means relevant factors to learn. The practice is action-oriented, through teaching by research, where the student is
challenged to solve, clinical cases. (Problem Based Learning)
The acquisition of knowledge is proven through a written test (60%) and carrying out a bibliographic review with
presentation and/or through problem-based learning cases discussion (40%).

O1. To provide students with the skills and competences in the scope of evaluating the safety of medicines throughout
their life cycle.
O2. To understand the principles of pharmacovigilance from the development of the science to its place in pre- and post-authorization environment and the roles of various stakeholders within pharmacovigilance.
O3. To acquire and deepen knowledge and the development of attitudes and behaviours that allow them a motivated
and adequate participation in the screening of adverse effects associated with the use of medicines and their
notification to the National Pharmacovigilance System.
O4. To identify, characterize and assess adverse drug reactions
O5. To enable student to develop an understanding of European regulations and guidelines concerning
pharmacovigilance.

1. General principles of Pharmacovigilance
1.1. Basic concepts of Pharmacovigilance
1.2. The National Pharmacovigilance System
1.3. Pharmacovigilance in Europe and Globally – EMA and WHO role
1.4. Spontaneous reporting of ADR
2. Adverse drug reactions
2.1. Concepts and definitions
2.2. Classification of adverse drug reactions according: Rawlins (A/B) and EIDOS/DoTS
2.3. Signal generation and detection – qualitative and quantitative methods of detecting signals.
2.4. Epidemiological methods applied to pharmacovigilance – Data sources for studies
2.5. Causality Assessment – theory and methods: Naranjo’s algorithm, WHO classification
3. Clinical aspects of ADR
3.1. ADR – Cardiovascular, Gastrointestinal, CNS, Respiratory, Ocular
3.2. Drug allergy and hypersensitivity
3.3. Safety of drugs in pregnancy and lactation
3.4. Safety of vaccines
4. Pharmacovigilance in clinical trials
4.1. Evaluation of drug safety
4.2. Preclinical safety assessment
4.3. European Pharmacovigilance regulation

NAO

Principal

Andrews, Elizabeth B., and Nicholas Moore, eds. Mann’s Pharmacovigilance. John Wiley & Sons, 2014.
Kaeding, M., Schmälter, J., & Klika, C. (2017). Pharmacovigilance in the European Union.
Aronson, J. K. (Ed.). (2015). Meyler’s side effects of drugs: the international encyclopedia of adverse drug reactions and
interactions. Elsevier.
INFARMED (2019) – “Farmacovigilância em Portugal: 25 anos”
van Eekeren, R., Rolfes, L., Koster, A. S., Magro, L., Parthasarathi, G., Al Ramimmy, H., … & Härmark, L. (2018). What
future healthcare professionals need to know about pharmacovigilance: introduction of the WHO PV core curriculum for university teaching with focus on clinical aspects. Drug safety, 41(11), 1003-1011.

Secondary

Mann, Ronald D., and Elizabeth B. Andrews, eds. Pharmacovigilance, 2007.
World Health Organization. (2002). The importance of pharmacovigilance.
Fornasier, G., Francescon, S., Leone, R., & Baldo, P. (2018). An historical overview over Pharmacovigilance.IJCP,40(4), 744-747.
Ferner, Robin E., and Jeffrey K. Aronson. “EIDOS.” DrSaf 33.1 (2010): 15-23.
Lodola, A., & Stadler, J. (Eds.). (2011). Pharmaceutical Toxicology in Practice: A Guide to Non-clinical Development.John Wiley & Sons.
 Aronson, J. K. (2009). Medication errors: definitions and classification. BJCP, 67(6), 599-604.
 Rolfes, L. (2018). Patient participation in pharmacovigilance: Rijksuniversiteit Groningen.