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Regulatory Affairs Course of Medicines

Code 13703
Year 5
Semester S1
ECTS Credits 3
Workload PL(15H)/T(15H)
Scientific area Ciências Farmacêuticas
Entry requirements Although there are no other special entry requirements, it is suggested to approve the related curricular units taught in previous years of the course.
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.
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.
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
Language Portuguese. Tutorial support is available in English.
Last updated on: 2018-07-30

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