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REGULATORY ASPECTS OF THE PRODUCTION AND PLACING ON THE MARKET OF BIOLOGICALLY ACTIVE SUBSTANCES, MEDICINES AND MEDICAL DEVICES OF BIOTECHNOLOGICAL ORIGIN

CODE 109046
ACADEMIC YEAR 2022/2023
CREDITS
  • 2 cfu during the 3nd year of 8756 BIOTECNOLOGIE (L-2) - GENOVA
  • SCIENTIFIC DISCIPLINARY SECTOR CHIM/09
    LANGUAGE Italian
    TEACHING LOCATION
  • GENOVA
  • SEMESTER 2° Semester
    TEACHING MATERIALS AULAWEB

    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 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

     

    TEACHERS AND EXAM BOARD

    LESSONS

    Class schedule

    All class schedules are posted on the EasyAcademy portal.

    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.