OVERVIEW

The preliminary evaluation of quality, efficacy and safety of biologically active substances, medicines and medical devices implies the technical knowledge of several national and international rules regulating the world of health products. The Regulatory Affairs is a key area in the contemporary organization of the pharmaceutical and medical devices industry, hiring many graduates in scientific disciplines with a solid preparation in the technical-regulatory aspects regulating this important industrial area.

AIMS AND CONTENT

LEARNING OUTCOMES

This course intends to introduce the regulatory classification of medicines and medical devices, also defining the value of the commercial market and outlining the authorization processes that allow the industrial production and marketing of these products, with particular attention to EU regulations. The organization and functions of the most important regulatory agencies, such as EMA, AIFA and FDA, and other bodies involved, such as the Ministry of Health, ISS, EDQM, WHO, and ICH, will also be studied in defining the guidelines governing these important sectors.

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.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturers and to the dedicated SLD Representative in the Department before class begins, in order to liase and arrange the specific teaching methods and ensure proper achievement of the learning aims and outcomes.

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

TEACHERS AND EXAM BOARD

Exam Board

GIORGIA AILUNO (President)

GABRIELE CAVIGLIOLI (President)

SARA BALDASSARI

LESSONS

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam involves passing a written test composed of multiple-choice questions.

ASSESSMENT METHODS

The exam evaluates the knowledge of the main rules regulating the production and marketing of medicines and medical devices of biotechnological origin.