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Presentation
Presentation
The CU Structures and Organization of the Pharmaceutical Industry aims to provide a global view of the dimension and diversity of the activities and departments of the pharmaceutical industry, from the discovery of new molecules to the placement and promotion in the markets of products of the pharmaceutical industry.
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Class from course
Class from course
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Degree | Semesters | ECTS
Degree | Semesters | ECTS
Bachelor; Master Degree | Trimestral | 4
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Year | Nature | Language
Year | Nature | Language
5 | Mandatory | Português
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Code
Code
ULHT477-16585
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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. Organizational models. Departments 2. Research and development. 3. Clinical Trials 4. Medical affairs and pharmacovigilance. 5. Production and quality control 6. Pharmacoeconomics and Market Access 7. Regulatory Affairs 8. Pharmaceutical Marketing and Product Management 9. Sales 10. Distribution and logistics 11. Governmental Affairs and Communication
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Objectives
Objectives
Students should understand the structure and organization of the pharmaceutical industry, recognizing the main organizational models and the functions of its different departments. They are expected to acquire knowledge of the medicine life cycle, from research and development to commercialization and post-market monitoring, including clinical trials, pharmacovigilance, manufacturing, quality control, regulatory affairs, market access and logistics. Skills will be developed to critically analyze the role and interconnection of each functional area, as well as to interpret scientific, regulatory and market information. Students should also strengthen communication and integrative analysis competences, preparing for future roles in multidisciplinary teams within the pharmaceutical sector.
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Teaching methodologies and assessment
Teaching methodologies and assessment
The course unit is mainly organized in a seminar format with external guest speakers, specialists in different areas of the pharmaceutical industry. It also includes a “Field Work” component through a study visit to a pharmaceutical company, integrated into PharmaWeek – Lusófona Week of Contact with the Pharmaceutical Profession.
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References
References
http://www.apifarma.pt/Paginas/Home.aspx http://www.infarmed.pt/portal/page/portal/INFARMED http://www.ema.europa.eu/ema/ Jacobsen, T. Werthermer, A. (2009) Modern Pharmaceutical Industry. Jones and Bartlett Publishers, LLC
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Office Hours
Office Hours
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Mobility
Mobility
No