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.

AIMS AND LEARNING OUTCOMES

Active attendance at laboratory exercises will allow the student to acquire the main techniques of galenic formulation by deepening the knowledge of the main solid, semi-solid and liquid pharmaceutical forms, covered in the previous course of Pharmaceutical Technology and Legislation I.

The course of Pharmaceutical Technology II will allow the student to acquire the knowledge of the main industrial processes of active ingredients and medicinal production, of company organization and management of the production resources.

The Pharmaceutical Legislation part of the course will allow the student to acquire knowledge of the main rules governing the production and marketing of medicines and other health products, as well as knowledge of the National Health Service and the government of public pharmaceutical expenditure.

At the end of the course the student will have to demonstrate:

understanding of the main industrial production technologies of active ingredients and medicines and of the regulations governing the production and trade of medicines;

to be able to classify medicines distinguishing them from other health products;

must be able to plan the industrial production process of a pharmaceutical form by selecting the most suitable production units for the pharmaceutical form in production and the extent of production in a GMP environment.

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.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer(s) and to the dedicated SLD Representative in the Department ( Prof. Luca Raiteri, Luca.Raiteri@unige.it ) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 10 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni

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

GIORGIA AILUNO (Substitute)

GIANCARLO GROSSI (Substitute)

ELEONORA RUSSO (Substitute)

GUENDALINA ZUCCARI (Substitute)

LESSONS

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam consists of passing the following tests:

- practical test of preparation of two galenic  prescribe dosage forms; 

- written test, with multiple choice questions, relating to the part of the legislation and pharmacoeconomics;

-oral test relating to both the technology and the regulatory and pharmacoeconomic aspects.

In detail:

access to the exam will be conditional on passing the practical evaluation tests of what has been learned during the laboratory exercises.

The exam will involve passing a written test, consisting of 10 multiple choice questions on Pharmaceutical Legislation and Pharmacoeconomics topics, to be solved in 7 minutes: a score of 1/10 will be assigned to each correct answer. Starting from the second incorrect answer, a penalty of -1/10 on the final grade will be attributed.

Only with the minimum score of 5/10 will it be possible to access the oral exam.

The oral exam will focus on the correction of the written paper, with insights into the Legislative aspects, and on the Pharmaceutical Technology program.

The final grade will result from the weighted average of the oral grade (70%) and the written grade expressed in thirtieths (30%).

 In case of insufficient exam mark or if you do not attend the oral exam or withdraw from it, the written test must also be repeated

ASSESSMENT METHODS

The practical skills will be evaluated with the results of the laboratory tests.

The knowledge of the regulatory aspects, in particular in function of "problem solving", will be assessed in the written test.

The overall deepening of the knowledge of the Technological and Regulatory aspects of pharmaceutical production will be evaluated in the context of the oral exam.

Exam schedule