Pharmaceutical Market and Regulatory Aspects of Health Products
A.Y. 2022/2023
Learning objectives
The course aims to provide knowledge on the characteristics, trends and economic aspects that govern the market for pharmaceutical products, with particular reference to that of generics. Another educational objective of the course is to introduce national and European rules concerning production, placing on the market and distribution of health products, such as cosmetics, food supplements or food for specific groups.
Expected learning outcomes
At the end of the course the student will have a comprehensive view of the main economic and regulatory aspects of drug, cosmetic and health products for their management both in industry and in pharmacy.
Lesson period: year
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
year
Prerequisites for admission
Basic knowledge of statistics and data representation; knowledge of the pharmaceutical and pharmacological glossary and of the main types of medicinal and health products on the market.
Assessment methods and Criteria
Learning assessment is based on separate tests and the final mark is calculated as the average of the marks achieved in the two tests. For both modules the test involves the discussion of a case study through a presentation with slides and oral examination. The final evaluation will be based on the outcome of the group presentation of the topic selected in agreement with the teacher for 60%, on the oral examination for 20% and on a further 20% both for class attendance and coordinated contribution during classes.
Pharmaceutical market
Course syllabus
The pharmaceutical market
The role of marketing in pharmaceutical companies and pharmacies
Marketing Authorization of Generics
Patent issues
Biopharmaceutical aspects of oral solid dosage forms
Bioequivalence / Interchangeability
Substitution in pharmacies and pharmacists' responsibilities
"Liste di Trasparenza"
The role of marketing in pharmaceutical companies and pharmacies
Marketing Authorization of Generics
Patent issues
Biopharmaceutical aspects of oral solid dosage forms
Bioequivalence / Interchangeability
Substitution in pharmacies and pharmacists' responsibilities
"Liste di Trasparenza"
Teaching methods
Lectures
Teaching Resources
Slides of the lessons provided by the teacher in class
Regulatory aspects of health products
Course syllabus
Regulatory aspects of foods with particular reference to: Regulation apply to nutrition and to health claims; Novel food legislation; Regulation on Food for Specific Groups; food supplements including botanical substances. EU regulation of cosmetics. Outline of regulatory aspects concerning Medical Devices, with particular reference to Medical Devices that are composed of substances.
Teaching methods
Lectures
Teaching Resources
Slides of the lessons provided by the teacher in class.
Pharmaceutical market
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professors:
Foppoli Anastasia Anna, Maroni Alessandra
Regulatory aspects of health products
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor:
Casiraghi Antonella
Professor(s)
Reception:
by appointment
via G. Colombo 71
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71