Regulation and Evaluation of Medicines and Health Products
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.
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.
Access and ingress
Holders of a bachelor's degree or legal equivalent in the scientific areas of the course.
