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Regulation and Evaluation of Medicines and Health Products

Regulation and Evaluation of Medicines and Health Products

Degree 
MSc - Master Degree
School 
Faculty of Pharmacy
Time period 
Pós-laboral
Duration 
4
ECTS 
120
Language 
EN
Data de Acreditação A3ES 
10/06/2023
Prazo de Acreditação A3ES 
6 anos
Official Portuguese Code (DGES) Number 
R/A-Ef 1959/2011
Official Portuguese Code (DGES) Registration Date 
03/18/2011

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The Master's study cycle in Regulation and Evaluation of Medicines and Health Products lasts 2 academic years, organized into 4 semesters, and aims to train specialists in the regulatory affairs of medicines ("Regulatory Affairs") integrated with the scientific components of its life cycle.

Objectives 

This course aims to increase de knowledge on all the regulatory aspects, laws and directives, science based approaches on the Marketing authorisation in European Union for Medicinal Human Medicines and Veterinary Medicines. Furthermore, this course will include legislation in Health Products based on Medicinal Plants, Medical Devices as well as patent laws, price regulation and others.

This course will also guarantee the training of professionals that can work and solve complex issues in regulatory affairs and can contribute to optimize decision making process.

Career prospects 
The course trains specialists in Regulatory Science, conferring general and specific knowledge about the studies that are part of the drug development from small molecules to biotechnological drugs or gene or cellular basis, in the perspective of technical-scientific and regulatory requirements in terms of studies and methodologies. These specialists will have competencies to carry out professional activities in Regulatory Drug Agencies, in Research and Regulation Departments of Pharmaceutical Industries, as well as in the Research Institute of Medicine and in the Academy.
Vacancies 
35
National Admission Exams 
Holders of a bachelor's degree or legal equivalent in the scientific areas of the course.
Fee – 1st year (indicative) 
4500.00€
Fee - remaining years (indicative) 
1100.00€

International Access

Fee - 1st year (indicative) 
4500,00€
Fee - remaining years (indicative) 
1100,00€