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Presentation
Presentation
The Curricular Unit's objective is to develop skills in the application of specialized knowledge, according to the technical-scientific opinions issued by the Authorities and their groups of experts (eg SCCS, EFSA; WHO; FAO; CODEX Notification Bodies Guidelines), knowing how to locate , interpret and implement national and international references (Diário da República; EU Official Journal; EMA Guidelines), in the most relevant areas of health product regulation (which includes medical devices, cosmetic and body care products) and food supplements.
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Class from course
Class from course
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Degree | Semesters | ECTS
Degree | Semesters | ECTS
Master Degree | Semestral | 2
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Year | Nature | Language
Year | Nature | Language
1 | Mandatory | Português
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Code
Code
ULHT2629-17181
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Prerequisites and corequisites
Prerequisites and corequisites
Not applicable
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Professional Internship
Professional Internship
Não
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Syllabus
Syllabus
Introduction - European Surveillance Systems (foodstuffs, non-food products and non-medicines). International Scientific Committees and Scientific Opinions. Databases from the EU, FDA, Canada and Australia.
- Access to national and international notification systems for quality defects, adverse effects or product acceptance / rejection. Case studies.
- European Alert Networks - operating rules.- RAPEX- RASFF
- Access to international systems (FDA, Codex Alimentarius, WHO) and critical analysis (e.g., USP Dietary Supplements).
- Integrated simulated practice
- Access to national and international notification systems for quality defects, adverse effects or product acceptance / rejection. Case studies.
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Objectives
Objectives
Skills to be developed during classes:
- Search and analyze technical-scientific and regulatory information on health products and food supplements in the form of case studies
- To know and apply the concepts related to regulation to the simulated design of health products and food supplements
- Integration of student knowledge that allows the performance of professional functions in these areas or to improve professional performance, if already working in the area.
The Course Unit consists of two training fields (Regulation of health products and Regulation of food supplements).
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Teaching methodologies and assessment
Teaching methodologies and assessment
Innovative methodologies to support the teaching-learning process used: - Resolution of real cases that are ongoing in Authorities of each area of ¿¿the MPSSA in collaboration with employees of these institutions - Permanent consultation of numerous international databases
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References
References
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Regulamento (CE) nº 178/2002 de 28 de janeiro
Estabelece, no seu artigo 50º, um sistema de alerta rápido em rede para a notificação de riscos diretos ou indiretos para a saúde humana, ligados a géneros alimentícios ou a alimentos para animais.
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Regulamento (CE) nº 1161/2011 de 14 de Novembro de 2011 que altera a Directiva 2002/46/CE do Parlamento Europeu e do Conselho, o Regulamento (CE) nº 1925/2006 do Parlamento Europeu e do Conselho e o Regulamento (CE) nº 953/2009 da Comissão no que se refere às listas de substâncias minerais que podem ser adicionadas aos alimentos.
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Office Hours
Office Hours
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Mobility
Mobility
No
