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TECNOLOGIA E LEGISLAZIONE FARMAC. II (CON ESERC.)(LM CTF)

CODE 67615
ACADEMIC YEAR 2021/2022
CREDITS
  • 10 cfu during the 5th year of 8451 CHIMICA E TECNOLOGIA FARMACEUTICHE (LM-13) - GENOVA
  • SCIENTIFIC DISCIPLINARY SECTOR CHIM/09
    LANGUAGE Italian
    TEACHING LOCATION
  • GENOVA
  • SEMESTER 1° Semester
    PREREQUISITES
    Prerequisites
    You can take the exam for this unit if you passed the following exam(s):
    • Pharmaceutical chemistry and technology 8451 (coorte 2017/2018)
    • GENERAL AND INORGANIC CHEMISTRY (PCT)(MD) 55401
    • MATHEMATICS (PCT)(MD) 55402
    • PHYSICS (PCT)(MD) 55404
    • PHYSICAL CHEMISTRY (MD) 60821
    • ORGANIC CHEMISTRY I (PCT)(MD) 60822
    • ORGANIC CHEMISTRY II (PCT)(MD) 60828
    • PHARMACEUTICAL TECHNOLOGY AND LAW I (PCT) 67569
    • MEDICINAL AND TOXICOLOGICAL CHEMISTRY I 80446
    TEACHING MATERIALS AULAWEB

    OVERVIEW

    The course of Pharmaceutical Technology and Legislation II is a professional teaching oriented to the formation of the CTF that intends to carry out its activity in the industrial field both in the functions of production worker and control of the preparation of active ingredients and medicines as well as those employed to preclinical and clinical research in GMP system.

    AIMS AND CONTENT

    LEARNING OUTCOMES

    The learning outcomes is the study of  the organization of pharmaceutical industry, through the in-depth understanding of the processes and equipment used in the industrial manufacturing of active ingredients and medicinal products. The regulatory aspects of the production and vigilance of the drugs and of other products having medical or healthy significance are also presented and discussed. Furthermore, a large number of individual practice exercises for the preparation of main dosage forms involving the use of laboratory instrumentation are provided.

    TEACHING METHODS

    The course takes place in 120 hours of frontal teaching activities and individual laboratory exercises. These tutorials are guided and assisted by the teacher. In the classroom during the lectures the teacher carries out the whole teaching program. On Aulaweb, the lecturer notes of the course are provided on request to the students attending, divided into the different chapters of the program and updated annually by the teacher, where all the topics dealt with in the classroom are widely reported.

    SYLLABUS/CONTENT

    Pharmaceutical Technology

    The pharmaceutical industry

    Organization: local, working environment and centralized technical services

    Equipment and plants of pharmaceutical industry

    Process and production water

    Drying

    Grinding of solids, sieving and mixing of the powders

    Hard capsule filling process and equipment

    Compaction, Mixing and Granulation

    Tablet compression machines

    Coating process and equipment

    Semisolid production and filling equipment

    Suppository process and equipment

    Dosage liquid form production and filling equipment

    Sterilization and sterile dosage form production

    Pressurized dosage form production

    Biotechnological equipment and processes

    Packaging

     

    Pharmaceutical Law

    Sources of law.

    Organization of national health service (SSN) and basics of Pharmacoeconomy.

    Supranational bodies and organizations for the protection of health.

    Juridical definition of medicinal product

    Regulatory and administrative classification of medicines

    AIFA and EMA and their functions within the European Medicines Control System

    EU rules for authorizing the production and marketing of the Api and medicinal products for human use

    Patents

    Clinical trials

    Orphan Medicinal and compassionate use

    Generic name medicinal products.

    EU Regulation of homeopathic medicines.

    Presentation of medicines: label and leaflet.

    Pharmacovigilance.

    The medical-scientific information and advertising in the pharmaceutical field.

    Discipline of veterinary medicines.

    Medical devices.

    In vitro diagnostic medical devices.

    Biocides, ECA and Plant protection products.

    Regulatory issues concerning: special foods, mineral water, herbal products from non-medicinal plants, sweeteners, alcohol, cosmetics.

    Standards concerning environmental protection: classification, storage and disposal of waste with particular reference to the pharmaceutical and health aspects.

    Laboratory of Galenic dosage form preparation and industrial microscale production: the course includes a series of individual laboratory session for the preparation of classical dosage forms and for use of lab equipment for the pharmaceutical R&D.

    RECOMMENDED READING/BIBLIOGRAPHY

    Remington: The Science and Practice of Pharmacy. Edited by Allen, Loyd V., Jr

    Pharmaceutical Press; 22th edition (Septmber 2012).   

    The Theory and Practice of Industrial Pharmacy, III Ed. - Lachman L. e coll.- Lea & Febiger, Philadelphia 1986.

    Suggested consultation textbooks are:

    Aulton Tecnologie farmaceutiche [Aulton's pharmaceutics]  Aulton, Michael E. ; Taylor, Kevin M. G. ; Milano : Edra, 2015.

    La Fabbricazione Industriale Dei Medicinali- L. Fabris, A. Rigamonti- Società Editrice Esculapio-2008.

    Legislazione Farmaceutica - P.Minghetti – nona edizione CEA, Milano 2018.

    TEACHERS AND EXAM BOARD

    Exam Board

    GABRIELE CAVIGLIOLI (President)

    SARA BALDASSARI

    GIANCARLO GROSSI

    ELEONORA RUSSO

    GUENDALINA ZUCCARI

    GIORGIA AILUNO (Substitute)

    LESSONS

    Class schedule

    All class schedules are posted on the EasyAcademy portal.

    EXAMS

    Exam schedule

    Date Time Location Type Notes
    20/04/2022 15:00 GENOVA Scritto + Orale
    20/06/2022 15:00 GENOVA Scritto + Orale
    01/07/2022 15:00 GENOVA Scritto + Orale Presentarsi con documento di identità in corso di validità
    18/07/2022 15:00 GENOVA Scritto + Orale
    06/09/2022 15:00 GENOVA Scritto + Orale
    24/01/2023 15:00 GENOVA Scritto + Orale
    13/02/2023 15:00 GENOVA Scritto + Orale