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Regulatory Science and Clinical Affairs

Regulatory Science and Clinical Affairs

Degree 
MSc - Master Degree
School 
Faculty of Medicine
Time period 
Day time
Duration 
4
ECTS 
120
Language 
PT
Data de Acreditação A3ES 
07/31/2023
Prazo de Acreditação A3ES 
6 anos
Official Portuguese Code (DGES) Number 
R/A-Cr 174/2023
Official Portuguese Code (DGES) Registration Date 
12/14/2023

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Regulatory Science is defined as the set of scientific disciplines that inform regulatory decision-making throughout the lifecycle of a product and apply to the quality, safety assessment, and effectiveness of health products. It involves biomedical and social sciences, both basic and applied, and contributes to the development of regulatory standards and tools. Therefore, it is interdisciplinary and applies across all medical fields and health sciences in general. It is a strongly multidisciplinary area whose purpose is to build a regulatory system that encourages innovation and effectiveness in the clinical development process of products, facilitates the access of innovation to citizens, as well as its monitoring throughout the product's life.

Objectives 

Provide in-depth knowledge of Regulatory Science applied at a national and international level, the way in which the different actors
collaborate in regulation and the current needs of the system to which the Academy must contribute. main regulatory structures, their
powers and duties, applicable legislation and regulations. Students acquire basic competence in the various methodologies used for
quality control and pre-clinical development of health products, and will develop knowledge and skills in the field of medicine related
to the clinical development of products, as well as their follow-up throughout the product's life cycle. The pre-defined objectives are in
line with the FMUL's Mission and the strategy it has been developing in the postgraduate area. In addition, they reinforce the
scientific and pedagogical components.

Career prospects 
• This program aims to provide professional training in this area, which will facilitate applications for research projects in the area of ​​regulatory science • Integration into multidisciplinary teams in the pharmaceutical industry, in the regulatory authority and in assistance areas (ULS/Hospital Pharmacy and Therapeutics Committees); • Integration into research and innovation teams in regulatory science with the promotion of collaborations between the university and scientists in the regulatory network to address research questions in emerging regulatory sciences;
National Admission Exams 
Graduates/Integrated Masters or legal equivalents in Medicine, and other areas of Health Sciences and related areas, biomathematics, biomedical engineering, as well as professionals from the pharmaceutical industry can apply for this EC. Holders of a foreign higher academic study, in the same areas, granted following a 1st cycle organized in accordance with the principles of the Bologna Process or that are recognized as satisfying the objectives of the licentiate degree by the scientific and statutorily competent body.
Further Information: 
New cycle of studies