Curricular Unit:			Code:
Medication and Market Authorization and Placement			1069MAIM
Year:	Level:	Course:	Credits:
1	Postgraduate	Regulatory Affairs of Medication and Health Products	1 ects
Learning Period:		Language of Instruction:	Total Hours:
		Portuguese/English	13
Learning Outcomes of the Curricular Unit:
In module I - Medicines and Marketing Authorization - of the Postgraduate Degree in Regulatory Affairs of Medicines and Health Products, the competences to be acquired include: to know the circuit and the European medicine system; to know and be able to interpret and elaborate a common technical document (CTD); to know the circuit and the methodology of health technologies evaluation.
Syllabus:
1 - European Medicines System - main legal diplomas. European Medicines Agency. Infarmed I.P. Circuit of the medicine and the main legal diplomas that regulate it. Medicine Market and Medical Devices. 2 - Medicine. Procedures for Marketing Authorization. Technical Document - Common 3 - Module 3 of the CTD - Quality Evaluation of Active Substances and Pharmaceutical Forms. BD/BE. 4 - Module 4 of the CTD - Non Clinical Evaluation of Medicines 5 - Module 5 of the CTD - Clinical Evaluation of Drugs
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 medicines, medical devices, cosmetic and body hygiene products and food supplements, to work in the different areas of regulatory affairs. The program contents of Module I aim at the acquisition of competences regarding the regulatory aspects for the application for a marketing authorization of a medicine in the European system, including the knowledge, interpretation of information and preparation of a common technical document.
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:
EMA (European Medicines Agency) webpage - https://www.ema.europa.eu/en INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P., webpage - https://www.infarmed.pt/