| Code |
13703
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| Year |
5
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| Semester |
S1
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| ECTS Credits |
3
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| Workload |
PL(15H)/T(15H)
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| Scientific area |
Ciências Farmacêuticas
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Entry requirements |
To be a student of Integrated Master’s Degree in Pharmaceutical Sciences that meets the conditions to attend the 5th year of the course.
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Learning outcomes |
To enable the students with general and specific knowledge underlying the regulatory issues applicable to human medicinal products, both at National and European level. To prepare the students with key specific knowledge in order to enable them to acquire skills for the organization and preparation of marketing authorization application (MAA) dossiers of medicines. To afford the students with knowledge and skills regarding the main regulatory procedures to consider in managing the maintenance of a MAA and required in the strategic planning throughout the lifecycle of a medicine.
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Syllabus |
Regulatory affairs in European Union (EU) and European regulatory system for human medicines. National and EU legislation and guidelines (Eudralex). The role of the regulatory affairs professional. Drug development under regulatory compliance: current Good X Practices (cGxP – GMP, GLP, GCP). Nonclinical development, pharmaceutical development and quality, clinical development, and pharmacovigilance and risk management. Marketing authorization application dossier: content and format. Common Technical Document (CTD) and eCTD. Centralized, mutual recognition, decentralized and national procedures. Types of applications: complete, generic, hybrid, well-established use, fixed combination, and informed consent applications, and traditional use registration for herbal medicinal products. Lifecycle management: key elements for the maintenance of a marketing authorization. Line extension and variation applications. Legal status, renewal and periodic safety reports.
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Main Bibliography |
- International Conference Harmonization Guidelines for Human
- European Medicines Agency Scientific Guidelines for Human Medicinal Products
- EU Legislation – Eudralex: http://ec.europa.eu/health/documents/eudralex/index_en.htm
- EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use.
- INFARMED, I.P.: http://www.infarmed.pt/portal/page/portal/INFARMED/MEDICAMENTOS_USO_HUMANO/AUTORIZACAO_DE_INTRODUCAO_NO_MERCADO
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Teaching Methodologies and Assessment Criteria |
The pedagogic activity takes place in a face-to-face system. The theoretical classes allow to teach the mentioned topics in a predominantly classical mode of interaction, while the laboratory-practical classes take place in a tutorial system in which the learning process is centered in the student. This approach encourages an active student participation in the learning process, allowing the development of reasoning and communication skills, and the discussion and integration of the contents underlying the learning objectives defined.
Assessment – Methods and criteria:
1. Continuous and periodic evaluation (T and PL)
2. Final examination
Approval requires the final classification of at least 10 values (rounded) in 20 values. It also requires compliance with the conditions for granting frequency [minimum attendance: 70% (T) and 100% (PL); minimal rating in the teaching-learning period of 6 values (rounded) in 20 values; and presence in all assessment tests].
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Language |
Portuguese. Tutorial support is available in English.
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