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Presentation
Presentation
The Regulatory Affairs curricular unit allows to acquire skills and knowledge, in the most important areas of regulation of health products (including medical devices, cosmetics and body care) 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 | 6
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Year | Nature | Language
Year | Nature | Language
1 | Mandatory | Português
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Code
Code
ULHT2629-17176
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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
Unit 1. Regulation of health products
Device Regulation Doctors and Cosmetics
General concepts of regulation of health products and Medical devices:
- Border Demarcation and classification of medical devices
- Conformity assessment
- Registration of medical devices
Cosmetic products:
- Manufacture and import
- Safety AssessmentCosmetic market control
Pharmacovigilance and Surveillance Medical Devices
National and European system Pharmacovigilance
Risk management and mitigation measures
additional monitoringUnit 2. Regulation of food supplements
- General concepts of regulation of dietary supplements
- European System of Regulation and Competent Authorities
- Products-border Supplements and Medications
- Border Demarcation with medicinal products- the multivitamins, vitamins and minerals
- the "diet products" and "Naturopathy"
- The sweeteners and fat substitutes
- the Food Innovations and functional foods
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Objectives
Objectives
The aim of the course is to provide advanced training and the acquisition of skills and knowledge in a systematic way, in the most important areas of regulation of health products (including medical devices, cosmetics and body care) and food supplements.
Skills developed during the classes:
- Search and retrieve regulatory information about health products and food supplements
- Knowledge and aplication the concepts related to regulation of health products and food supplements
- Strengthening the knowledge that allow the performance of professional duties in this area or to improve their professional performance if already working in the area in question.
The Course consists of two training units (Regulation on health products and regulations applied to food supplements).
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Teaching methodologies and assessment
Teaching methodologies and assessment
Innovative methodologies to support the teaching-learning process used: 1. Tutoring of professionals from Competent Authorities with "hands-on" Sessions of real Cases (notification of a Supplementos Alimenatr on the DGAV page, issuance of Scientific Opinion to ASAE, etc.) for internalization of real professional skills in a real context. 2. Design of a "Product" with all justifications of Quality, Safety and Effectiveness compliance regardless of regulatory degrees of freedom - perception of what professional responsibility is.
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References
References
- União Europeia Com EU - Regulamento (UE) nº 432/2012 . [ 16 de maio de 2012, que estabelece uma lista de alegações de saúde permitidas relativas a alimentos que não referem a redução de um risco de doença ou o desenvolvimento e a saúde das crianças. JO, L 136:1-40
- Comissão Europeia , Parlamento EU, Regulamento (CE) nº 1924/2006. 20 de dezembro de 2006, relativo às alegações nutricionais e de saúde sobre os alimentos.JO,L404:9-25
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Office Hours
Office Hours
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Mobility
Mobility
No