Formulation and Regulatory Affairs of Health Products and Pharmaceutical Regulatory Affairs and Patents

A.Y. 2020/2021
8
Max ECTS
64
Overall hours
SSD
CHIM/09
Language
Italian
Learning objectives
The purpose of the course is to introduce the students to knowledge of the relevant European Community legislation concerning Marketing Authorization (MA), as required before the introduction on the market of a medicinal product. In particular biotechnological medicinal products, including biosimilars, are discussed. The legislative aspects of pharmaceutical patent will also be analyzed.
Moreover, the course provides knowledges to understand the right administrative classification and to evaluate the conformity to 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
The student will acquire the knowledge about legislative aspects of medicines for human use and the main health products.
Course syllabus and organization

Single session

Responsible
Lesson period
Second semester
Prerequisites for admission
To access the exam it will be necessary to have acquired knowledge of the topics covered in Pharmaceutical Technology.
Assessment methods and Criteria
Pharmaceutical regulatory affairs and patents: oral exam.
Formulation and regulatory affairs of Health products: discussion of a case study through a slide presentation.
Formulation and Regulatory Affairs of Health Products
Course syllabus
Regulatory aspects of foods with particular reference to:
- regulations concerning nutrition and health claims on food products and novel food products/ingredients;
- legislation of foodstuffs for particular nutritional uses;
- food supplements including botanical substances.
EU Regulation of cosmetic products.
EU Regulation of Medical Devices.
Teaching methods
Classes.
Teaching Resources
Lessons slides and additional material available on ARIEL website.
Pharmaceutical Regulatory Affairs and Patents
Course syllabus
Procedures for obtaining the Marketing Authorisation.
The Common Technical Document (CTD) and description of modules 3, 4 and 5.
European public assessment reports (EPARs)
Supplementary Protection Certificate (SPC).
Biotechnological medicinal products. Biosimilars.
Patents.
Aspects of marketing and merchandising: medicinal products' supply chain.
Healthcare issues. The price of medicinal products and pharmacoeconomic issues.
Teaching methods
Classes.
Teaching Resources
Lessons slides and additional material available on ARIEL website.
Formulation and Regulatory Affairs of Health Products
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Pharmaceutical Regulatory Affairs and Patents
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor: Minghetti Paola