Pharmaceutical market and Regulatory aspects of health products

A.Y. 2021/2022
8
Max ECTS
64
Overall hours
SSD
CHIM/09
Language
Italian
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.
Course syllabus and organization

Single session

Responsible
Lesson period
year
More specific information on the delivery modes of training activities for academic year 2021/22 will be provided over the coming months, based on the evolution of the public health situation.
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 oral examination for both parts of the course. Each exam is divided into 1-2 questions and the final mark is calculated as the average of the two.
Pharmaceutical market
Course syllabus
The pharmaceutical market
Principles of marketing
The role of marketing in pharmaceutical companies and pharmacies
Marketing Authorization of Generics
Patent issues
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 or of combinations of substances.
Teaching methods
lessons
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
Regulatory aspects of health products
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor(s)
Reception:
by appointment
via G. Colombo 71