Medicine and Regulatory Science
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.
3 reasons to choose this course
1.
Absolute multidisciplinarity.
2.
Transversality to all medical areas and health sciences including mathematical models and ecology.
3.
Acquisition of skills in various quality, preclinical, and clinical methodologies, contributing to the development and assurance of better drugs and health products.
Objectives
One of the major objectives of this course is to equip students with skills and develop knowledge in the field of medicine associated with the clinical development of products, their approval, market access, and citizen access, as well as monitoring throughout the drug's lifecycle. It also aims to impart skills in various methodologies used for quality control and chemical and preclinical developments of health products, and to develop knowledge and skills in the field of medicine related to the clinical development of products, as well as their monitoring throughout the entire lifecycle.
Skills acquisition
- Knowledge of the various structures involved in regulatory science, the different instruments and mechanisms of action, and the documentation used.
- Understanding of the different stages in the regulation of the product lifecycle, their objectives, and their own methodologies in various phases of the process, with a focus on clinical development and post-marketing, including reimbursement of medicines and pharmacovigilance.
- Understanding of the documentation used: its purposes, how it is updated, and how it should be produced and used.
- Ability to recognize and work with concepts, use legal frameworks, and engage with regulatory bodies and representatives.
- Ability to collaborate in the regulatory network, producing or updating documents and/or methodologies used.
- Competence in using regulatory science tools in different environments, particularly in building and managing databases for Real World Evidence/Real World Data.
- Providing students with skills in data management guidance rules and norms, the General Data Protection Regulation, data characteristics (especially sensitive health data), and ways to protect data and minimize the risk of corruption or misappropriation.
Target Students
Candidates holding bachelor's degrees/integrated master's degrees or legal equivalents in Medicine, as well as in other areas of Health Sciences and related fields such as biomathematics, biomedical engineering, and professionals from the pharmaceutical industry or regulatory authorities, are eligible to apply.
Career Opportunities
- This program aims to provide professional training in this area, which will facilitate applications for research projects in the field of regulatory science.
- Integration into multidisciplinary teams in the pharmaceutical industry, regulatory authority, and healthcare areas (Hospital Pharmacy and Therapeutics Committees) and in the pharmaceutical industry.
- Integration into research and innovation teams in regulatory science by promoting collaborations between the university and scientists in the regulatory network to address research issues in emerging regulatory sciences.
Coordination
Accreditation
