Curricular Unit:			Code:
Cosmetic and Body Hygiene Products and Food Supplements			1069PCHC
Year:	Level:	Course:	Credits:
1	Postgraduate	Regulatory Affairs of Medication and Health Products	0,8 ects
Learning Period:		Language of Instruction:	Total Hours:
		Portuguese/English	10
Learning Outcomes of the Curricular Unit:
In module 4 - Cosmetics and Body Hygiene Products and Food Supplements - of Postgraduate Diploma in Regulatory Affairs of Medicines and Health Products, the skills to be acquired include: knowing the circuit of Cosmetics and Body Hygiene Products and Food Supplements and knowing the process of introduction in the market of Cosmetics and Body Hygiene Products and Food Supplements.
Syllabus:
1 - Regulatory framework. Notification via the European e-Portal. Registration of Product Information. Safety Evaluation of Cosmetics. Labelling. 2 - Claimed effects of cosmetics. Cosmetovigilance. 3 - Regulatory framework of food supplements. European Food Safety Authority. Notification of food supplements. Importation of food supplements. Claimed effects. Borderline products.
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
The postgraduate course in Regulatory Affairs in Medicines and Health Products aims to prepare highly qualified professionals in regulatory affairs related to the area of medicine, medical devices, cosmetic and personal hygiene products and food supplements, to work in the different areas of regulatory affairs. The programmatic contents of Module 3 aim at the acquisition of skills regarding the regulatory aspects for the introduction in the market of Cosmetic and Toiletry Products and Food Supplements.
Teaching Methodologies (Including Evaluation):
The teaching regime of the Postgraduate Course in Regulatory Affairs of Medicines and Health Products is distance learning (online), through the CANVAS platform. The course will be assessed through attendance and participation during each session of the course and the presentation of a final paper/report on one of the topics taught during the course. The topic of the work will be selected by the student himself according to student`s professional interests.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
The evaluation in each module of the course will be carried out by the presence and interest/participation during each session. The final evaluation of the course through a final work/report will validate the scientific competencies and the systematisation of the knowledge acquired by the students. Additionally, the completion of this work / final report allows to deepen the knowledge in a more specific area of the course according to professional interests.
Reading:
INFARMED webpage - https://www.infarmed.pt/ DGAV (Direção Geral de Alimentação e Veterinária) webpage - https://www.dgav.pt