Pharmaceutical Market and Regulatory Aspects of Health Products
A.Y. 2025/2026
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
General pharmaceutical and pharmacological knowledge. Basic knowledge of the spreadsheet software program Excel.
Assessment methods and Criteria
Learning is assessed separately for the two parts, and the final mark is calculated as the average of the marks achieved. For both modules, the discussion of a case study, orally of through a slide presentation, will take place. The final evaluation will be based on the outcome of the discussion of the topic selected for 70%, and for 30% on attendance and active participation in classes
Pharmaceutical market
Course syllabus
Introduction to the pharmaceutical market and health economics. Overview of Market Access, from European authorization (EMA) to access in Italy: the pricing and reimbursement process for medicines. The role of AIFA and pharmaceutical companies in drug and health technology access, from the regulatory phase to patient dispensing. The role of consulting firms within the health economics field and the use of Health Technology Assessment. Economic tools for access: budget impact models and economic evaluations. The role of pharmacists in management, logistics, and prescribing appropriateness. Career opportunities in the field of market access.
Teaching methods
Lectures. In-class exercises and analysis of real cases (e.g., negotiations, regional access, corporate policy).
Teaching Resources
Slides and supplementary readings provided by the teacher and guest speakers, loaded on the MyAriel website. AIFA documents, HTA guidelines and negotiation criteria
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, loaded on the MyAriel website.
Modules or teaching units
Pharmaceutical market
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor:
Marcellusi Andrea
Regulatory aspects of health products
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor:
Casiraghi Antonella
Professor(s)