Technical-Regulatory Affairs
- Details
- Category: Discipline
- Malone, P., Kier, K., Stanovich, J. (2011). Drug Information, A Guide for Pharmacists. New York, NY: McGraw-Hill. Duarte, D., Martins, J. (2013, 1ª Edição). Comercialização de Medicamentos, Rotulagem e Folheto Informativo in Guerreiro M. Fernandes, A. Deontologia e Legislação Farmacêutica. Lisboa: Lidel ¿ Edições Técnicas. Pinheiro P. Gorjão-Henriques M. (2009). Direito do Medicamento. Coimbra Editora
- Pharmacy
- 4003
- 19582
- Technical-Regulatory Affairs
- IPLUSO4003-19582
- 2
- 5
- 0
- 4
- Não
- Português
- In this curricular unit, the Team-based learning (TBL) methodology is used, with tasks carried out in small groups, allowing the development of the ability to analyze and apply theoretical concepts.
- Mandatory
- Transmission of essential knowledge in the legal, technical-scientific and regulatory aspects inherent to medicines in order to provide students with the appropriate skills for a good professional performance in the different fields of medicine regulation. Provide students with a set of knowledge about new drug information technologies and health information systems. Provide knowledge of the concepts used at national and European level in the normative and legal framework of the medicine statute and medicine regulation. Sensitize students to the critical and reflective interpretation of drug regulation, which allows them to act correctly in the professional environment. Transmission of essential knowledge in aspects of good practice in pharmacy storage and distribution.
- 1. Information about medications - Sources and flow of information in Health. - Electronic databases: information search and retrieval - Health information technologies and systems. CIM : functions and activities. 2. Drug regulation - INFARMED - Legal regime for medicinal products for human use: from clinical trials to dispensing to the public. Good practices in drug storage and distribution in pharmacy - Special provisions and legal framework for some drug categories including MNSRM 3. European drug evaluation system - EMA ¿ European Medicines Agency - Medication evaluation: Common Technical Document (CTD). Quality, Safety and Effectiveness Assessment - Procedures for introducing and maintaining medicines on the market: National, Decentralized and Centralized - Drug Pharmacovigilance: Spontaneous notification of ADR.System - European and National Pharmacovigilance
Exemplo:
Descrição
Data limite
Ponderação
1º teste Teórico
dd-mm-yyyy
25%
2º teste Teórico
dd-mm-yyyy
25%
Resolução de exercícios/casos práticos
dd-mm-yyyy
50%
A classificação final (CF) da unidade curricular por avaliação contínua é obtida a partir das classificações obtidas na componente teórica (T) e na componente teórico-prática (TP). A componente teórica consta de duas frequências escritas relativas aos conteúdos teóricos. A classificação mínima em cada frequência é de 8 valores. A componente teórico-prática baseia-se numa aprendizagem ativa, recorrendo à pesquisa orientada, à resolução de exercícios sobre os conceitos abordados nas aulas teóricas. A classificação da componente teórico-prática deve ser igual ou superior a 9,5 valores. A classificação final é calculada a partir da seguinte fórmula: CF = 0,50 T + 0,50 TP. A classificação de todos os instrumentos de avaliação é expressa numa escala de 0 a 20 valores, sendo que o valor ponderado das classificações obtidas tem de ser igual ou superior a 9,5 valores.
- Semestral
- The Curricular Unit of Technical-Regulatory Affairs aims to provide students with knowledge and skills in the research and retrieval of health information, relevant to aspects relating to the regulation of medicinal products for human use at national and European level, and to good storage practices and drug distribution in pharmacy.
