LEARNING OUTCOMES

This class has the objective of introducing the regulatory classification of medicines and medical devices, also defining the commercial marketing value and outlining the authorization processes allowing the industrial production and the marketing of these products, with particular attention to the European regulation.

The organization and roles in the definition of the guide-lines regulating these important areas of the most important Regulatory Agencies (like EMA, AIFA and FDA) and of other institutions involved (like the Health Ministry, ISS, EDQM, WHO and ICH), will be described.

The educational objectives of the course are: to classify and compare, from the regulatory point of view, medicines and medical devices; to provide a basic knowledge of the rules regulating the production, control, surveillance and marketing of the biologically active substances and of the deriving medicines; to define the role and authority of the regulatory institutions involved.

AIMS AND LEARNING OUTCOMES

The objectives of the course are: to present the regulatory classification of products of biotechnological interest: medicines, medical devices and in vitro diagnostics; to provide a basic knowledge of the rules regulating the production, control, marketing and surveillance of the biologically active substances and medicines, for both human and veterinary use, mainly at the European level but also including some hints regarding the legislation of the extra-EU area; to study the different procedures for the marketing authorization (national, DCP, MR, centralized); to provide a basic knowledge of the rules regulating the production, control, marketing and surveillance  of the medical devices and of the medical devices for in vitro diagnostics, distinguished by the risk class; to mention some aspects related to the national legislation (CND legislation); to describe the structure and the functions of the regulatory institutions involved (Health Ministry, ISS, AIFA at the national level; EMA, EDQM, WHO, ICH at the international level). At the end of the course, the student should possess the basic knowledge of the legislation regarding the biotechnological products and should be able to state their differences.

PREREQUISITES

It is suggested to be aware of the main production techniques to obtain biotechnological products.

TEACHING METHODS

The course includes 16 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.

SYLLABUS/CONTENT

• Definition of medicinal product
• Regulatory classification of medicines
• European regulations for the authorization to the production and marketing of the active substances and medicinal products for human and veterinary use
• Biosimilar products
• Medical devices
• Medical devices for in vitro diagnostics

• Main regulatory agencies and institutions: Health Ministry, AIFA, ISS, EMA, EDQM, FDA, WHO, ICH

RECOMMENDED READING/BIBLIOGRAPHY

The attendance to the lessons and the material provided on Aulaweb are sufficient to prepare the final exam. For any further detailed-study, the recommended texts are the following:

• Legislazione farmaceutica, IX ed., Minghetti P., Casa Editrice Ambrosiana, 2018 and relevant updates.
• Legislazione farmaceutica nella pratica professionale, Barberini G. e Casettari L., Casa Editrice Piccin, 2021.
• European Pharmacopoeia (Ph. Eur.)
• The Pharmacopeia of the United States of America and the National Formulary