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

A.Y. 2017/2018
8
Max ECTS
64
Overall hours
SSD
CHIM/09
Language
Italian
Learning objectives
Undefined
Expected learning outcomes
Undefined
Course syllabus and organization

Single session

Responsible
Lesson period
Second semester
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; the legislation of foodstuffs for particular nutritional uses; food supplements including botanical substances. EU regulation of cosmetics.
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) and the 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.
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