2024
Regulatory Affairs
Name: Regulatory Affairs
Code: CMS13746I
3 ECTS
Duration: 15 weeks/78 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese
Presentation
This UC acquires knowledge and skills in the most relevant areas of regulation of all health products - medicines, medical devices and cosmetic and body care products, both at national and European levels.
Sustainable Development Goals
Learning Goals
The Regulatory Affairs curricular unit must allow to acquire knowledge and skills in the most relevant areas of regulation of all health products - medicines, medical devices and cosmetic products, both at national and European levels.
At the end of the CU, students should have skills and competences that allow them to:
1. understand the regulatory path of all health products
2. know the regulatory life cycle of medicines, medical devices and cosmetic products
3. know the competent national and European authorities and their role
4. interpret and apply the fundamental concepts of regulatory and safety issues related to medicines and health products
5. Know and search for legislative documents and guidelines, as well as obtain regulatory information on health products in the existing databases
6. Know and apply the concepts related to the regulation of health products.
At the end of the CU, students should have skills and competences that allow them to:
1. understand the regulatory path of all health products
2. know the regulatory life cycle of medicines, medical devices and cosmetic products
3. know the competent national and European authorities and their role
4. interpret and apply the fundamental concepts of regulatory and safety issues related to medicines and health products
5. Know and search for legislative documents and guidelines, as well as obtain regulatory information on health products in the existing databases
6. Know and apply the concepts related to the regulation of health products.
Contents
I - Regulatory framework - PT and EU: Medicines, Medical devices (MD), Cosmetic products, Competent national and European authorities - identification, competences and tasks
II - Regulatory system for medicinal products: Marketing Authorization Procedures (EU and PT), Marketing Authorization File (Common Technical Document), Amendments and revocation of the MA, New paradigms: Adaptive pathways and the PRIME program, Generics and Biosimilars
III Medical devices regulatory framework: Borderline products and risk classification; Essential requirements, technical documentation and conformity assessment; Registration, Coding, Traceability and Unique Identification
IV - Cosmetic products: Definitions, borders and claims; Manufacture and import. Labeling; Safety assessment - technical file; Control of the CP market
V - Post-marketing surveillance: pharmacovigilance, MD surveillance, cosmetovigilance.
II - Regulatory system for medicinal products: Marketing Authorization Procedures (EU and PT), Marketing Authorization File (Common Technical Document), Amendments and revocation of the MA, New paradigms: Adaptive pathways and the PRIME program, Generics and Biosimilars
III Medical devices regulatory framework: Borderline products and risk classification; Essential requirements, technical documentation and conformity assessment; Registration, Coding, Traceability and Unique Identification
IV - Cosmetic products: Definitions, borders and claims; Manufacture and import. Labeling; Safety assessment - technical file; Control of the CP market
V - Post-marketing surveillance: pharmacovigilance, MD surveillance, cosmetovigilance.
Teaching Methods
Master theoretical classes. Practical classes that include some study visits, namely to the competent authorities, and group work carried out under the guidance of the professors, with subsequent presentation and discussion in practical classes.
Teaching is complemented by an electronic component available on an e-learning platform.
Evaluation:
- Continuous: group work (30%) + theoretical exam (70%), or;
- Final: final exam (100%).
The minimum rating resulting from the weighted average is 9.5 points.
Teaching is complemented by an electronic component available on an e-learning platform.
Evaluation:
- Continuous: group work (30%) + theoretical exam (70%), or;
- Final: final exam (100%).
The minimum rating resulting from the weighted average is 9.5 points.
Certificações
