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Presentation
Presentation
This unit, integrated in the Pharmaceutical Sciences curriculum is oriented to the integration of students into new subjects in the legislative and regulatory context as well as in the regulatory environment that surrounds stakeholders activity.
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Class from course
Class from course
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Degree | Semesters | ECTS
Degree | Semesters | ECTS
Bachelor; Master Degree | Trimestral | 3
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Year | Nature | Language
Year | Nature | Language
4 | Mandatory | Português
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Code
Code
ULHT477-4551
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Prerequisites and corequisites
Prerequisites and corequisites
Not applicable
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Professional Internship
Professional Internship
Não
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Syllabus
Syllabus
1. Ethics & Law - Professional ethics vs Legislation vs Ethics - Rights vs Law vs Codes - Hierarchy of Laws - Public Health Policies - Regulatory framework and Regulation 2. Pharmaceutical legislation - Pharmaceutical Industry - Wholesalers - Pharmacies (Primary care services) - Hospital Pharmacies (service) - LVMNSRM Retail channel - Pharmacies - Public hospitals 3. Pharmaceutical Legislation - Current, New and Potential Products - Evolution and Market Potential - Medicines (Types / Associated entities / Context) - Cosmetics (Types / Associated entities / Context) - Medical Devices (Types / Associated entities / Context) - Food Supplements (Types / Associated entities / Context) - Biocides (Types / Associated entities / Context) 4. Pharmaceutical Legislation ¿ Marketing & Sales - Philosophy & Pricing strategy - Reimbursement & Market access - Communication & Advertising
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Objectives
Objectives
This unit, integrated in the Pharmaceutical Sciences curriculum is oriented to the integration of students into new subjects in the legislative and regulatory context as well as in the regulatory environment that surrounds stakeholders activity. In this sense, it provides to the students the regulatory profile and management in public and private sectors; the activities and border lines of the profession and stakeholders involved; and provide them an oriented vision for the product and the associated regulations for market introduction.
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Teaching methodologies and assessment
Teaching methodologies and assessment
Development of specific themes, of practical application as professionals. Identification and justification of the applicable legislation and regulations
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References
References
Legislação Aplicável. Livros e Artigos: Guerreiro, M & Fernandes, A (2013). Deontologia e Legislação Farmacêutica, Edições Lidel. Pita, JR (2010). A farmácia e o medicamento em Portugal nos últimos 25 anos. Debater a Europa, (2-3): 38-55. Dias, JP (1993). A formação da indústria farmacêutica em Portugal: os primeiros laboratórios (1890-1914). Revista Portuguesa de Farmácia, 43(4), pp.47-57. Jornais, Revistas, outras Publicações: Boletins Informativos e Página Electrónica (Ordem dos Farmacêuticos) Boletins Informativos e Página Electrónica (INFARMED) Código Deontológico (Ordem dos Farmacêuticos) Código De Ética FIP Bases de Dados (Centro de Documentação Farmacêutica) Diários da República e outra legislação relevante
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Office Hours
Office Hours
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Mobility
Mobility
No
