Formulation and Regulatory Affairs of Health Products and Pharmaceutical Regulatory Affairs and Patents
A.Y. 2018/2019
Learning objectives
Undefined
Expected learning outcomes
Undefined
Lesson period: Second semester
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
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
Professor:
Rocco Paolo
Pharmaceutical Regulatory Affairs and Patents
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor:
Minghetti Paola
Professor(s)