Protein engineering, drug delivery and regulatory aspects

A.A. 2019/2020
Insegnamento per
11
Crediti massimi
96
Ore totali
SSD
CHIM/08 CHIM/09
Lingua
Inglese

Struttura insegnamento e programma

Edizione attiva
Responsabile
Moduli o unità didattiche
Biopharmaceutical and formulation aspects
CHIM/08 - CHIMICA FARMACEUTICA - CFU: 0
CHIM/09 - FARMACEUTICO TECNOLOGICO APPLICATIVO - CFU: 0
Esercitazioni di laboratorio a posto singolo: 16 ore
Lezioni: 24 ore

Chemical biology and protein engineering
CHIM/08 - CHIMICA FARMACEUTICA - CFU: 0
CHIM/09 - FARMACEUTICO TECNOLOGICO APPLICATIVO - CFU: 0
Lezioni: 32 ore

Regulatory aspects of medicinal products
CHIM/08 - CHIMICA FARMACEUTICA - CFU: 0
CHIM/09 - FARMACEUTICO TECNOLOGICO APPLICATIVO - CFU: 0
Lezioni: 24 ore
Docente: Rocco Paolo

STUDENTI FREQUENTANTI
Prerequisiti e modalità di esame
he examination consists of an oral exam covering all topics discussed during the course, with the aim of assessing students' knowledge on of theoretical concepts and their applications for pharmaceutics and regulatory purposes.
Biopharmaceutical and formulation aspects
Programma
This module aims to examine the basic principles of the main routes of administration and to discuss their importance in designing a medicinal product.
Topics:
In-depth analysis of pharmacokinetics and biopharmaceutical aspects of the routes of administration.
Parenteral and ocular dosage forms: formulative approaches and controls.
Stability of a medicinal products.
Scaffolds for tissue engineering.
Water for pharmaceutical purposes: classification, requirements, production methods.
In-depth analysis of sterilised liquid preparations: filtration, sterilization, lyophilization.
Clean rooms and aseptic preparation.
GMP.
Metodi didattici
Lectures and practical training
Materiale didattico e bibliografia
slides will be provided (Ariel website)

Aulton's Pharmaceutics, The Design and Manufacture of Medicines
Edited by Michael E. Aulton and Kevin M.G. Taylor
Regulatory aspects of medicinal products
Programma
This module focuses on the regulatory issues related to the manufacturing and marketing of medicinal products.
EU Institutions and the European Medicines Agency (EMA).
Definition of medicinal product. Borderline products
EU Pharmaceutical Law.
Manufacturing Authorisation and Marketing Authorisation. Biosimilars.
The Common Technical Document.
Advanced Therapy Medicinal Products (ATMPs).
ATMPs regulatory aspects.
Good Manufacturing Practice for ATMPs.
Orphan medicines and drug repurposing. Medicines for children.
Labelling of medicinal products. Farmacovigilance.
Risk-mangement.
Patents.
Market access.
Metodi didattici
Lectures
Materiale didattico e bibliografia
Lessons slides (provided on Ariel)
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated text). https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1561371840991&uri=C…
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Consolidated text). https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1561371773824&uri=C…
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1561371980291&uri=C…
Treaty on European Union (Consolidated version 2016). https://eur-lex.europa.eu/collection/eu-law/treaties/treaties-force.html
Treaty on the Functioning of the European Union (Consolidated version 2016). https://eur-lex.europa.eu/collection/eu-law/treaties/treaties-force.html
STUDENTI NON FREQUENTANTI
Biopharmaceutical and formulation aspects
Programma
This module aims to examine the basic principles of the main routes of administration and to discuss their importance in designing a medicinal product.
Topics:
In-depth analysis of pharmacokinetics and biopharmaceutical aspects of the routes of administration.
Parenteral and ocular dosage forms: formulative approaches and controls.
Stability of a medicinal products.
Scaffolds for tissue engineering.
Water for pharmaceutical purposes: classification, requirements, production methods.
In-depth analysis of sterilised liquid preparations: filtration, sterilization, lyophilization.
Clean rooms and aseptic preparation.
GMP.
Regulatory aspects of medicinal products
Programma
This module focuses on the regulatory issues related to the manufacturing and marketing of medicinal products.
EU Institutions and the European Medicines Agency (EMA).
Definition of medicinal product. Borderline products
EU Pharmaceutical Law.
Manufacturing Authorisation and Marketing Authorisation. Biosimilars.
The Common Technical Document.
Advanced Therapy Medicinal Products (ATMPs).
ATMPs regulatory aspects.
Good Manufacturing Practice for ATMPs.
Orphan medicines and drug repurposing. Medicines for children.
Labelling of medicinal products. Farmacovigilance.
Risk-mangement.
Patents.
Market access.
Periodo
Primo semestre
Periodo
Primo semestre
Modalità di valutazione
Esame
Giudizio di valutazione
voto verbalizzato in trentesimi
Docente/i
Ricevimento:
previo appuntamento
Dip. Scienze Farmaceutiche - via G. Colombo, 71