Regulatory aspects in toxicology

A.A. 2017/2018
Insegnamento per
6
Crediti massimi
48
Ore totali
SSD
CHIM/09 IUS/14
Lingua
Inglese

Struttura insegnamento e programma

Edizione attiva
Responsabile
Moduli o unità didattiche
Legislation in European Union
CHIM/09 - FARMACEUTICO TECNOLOGICO APPLICATIVO - CFU: 0
IUS/14 - DIRITTO DELL'UNIONE EUROPEA - CFU: 0
Lectures: 24 ore
Docente: Pescio Paolo

Regulatory Aspects of Medicaments, Medical Devices and Health products
CHIM/09 - FARMACEUTICO TECNOLOGICO APPLICATIVO - CFU: 0
IUS/14 - DIRITTO DELL'UNIONE EUROPEA - CFU: 0
Lectures: 24 ore
Docente: Minghetti Paola

Prerequisiti e modalità di esame
No prerequisite is needed. The examination consists of an oral exam covering all topics discussed during the course, with the aim of assessing students' knowledge of theoretical concepts and their applications for regulatory purposes.
Regulatory Aspects of Medicaments, Medical Devices and Health products
Programma
The main topic that will be discussed are reported below:
1. Law Sources and Institutional Bodies.
2. Definition of medicinal product- biotechnological products.
3. Marketing Authorization - The Common Technical Document.
4. Ionizing radiations and radioprotection.
5. Visit to Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico.
6. CTD Module IV - non-clinical toxicological studies.
7. Guidelines on biotechnological medicinal products.
Legislation in European Union
Programma
In each module of 4 hours the regulatory framework will be discussed with practical examples (i.e., relevant for the industry) and case studies.
The main topic that will be discussed are reported below:
-REACH regulation, key European regulation aimed to improve the protection of human health and the environment from the risk that can be posed by chemicals
-CLP regulation for the classification, labelling and packaging of chemicals
-BPR regulation concerning the placing on the market and use of biocidal products used to protect humans, animals, materials or articles against harmful organisms
-European Directive on Medical Device with focus on essential requirements; basic principles of ISO 10993-1 for the evaluation of the biocompatibility of medical devices (pre-clinical tests on animals); key-points of the (not-yet officially released) new regulation for medical devices;
-Permitted Daily Exposure (PDE) determination -EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (cleaning validation); Tolerable Exposure (TE) determination for the release of compounds from pharmaceutical packaging and medical devices
-OECD Guideline: principles behind in vivo and in vitro testing
Materiale didattico e bibliografia
· Guidance For Industry And FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
· ISO10993 series, Biological evaluation of medical devices www.iso.org
· ISO14971:2007, Medical devices — Application of risk management to medical devices.
· European Parliament And Council Of The European Union, REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 2017: Official Journal of the European Union.
· US CFR-Code of Federal Regulations Title 21 - Chapter 1, subchapter A - Part 73 and 74.
· FDA Recognized Consensus Standards - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.c…
· United States Pharmacopoeia: USP40-NF35 . The United States Pharmacopeial Convention.
· Crump, K. (1984). A new method for determining allowable daily intakes. Fund. Appl. Toxicol. 4, pp. 854-871
· A. Woolley "A guide to practical toxicology - 2 edition" Informa 2008
· International Conference On Harmonization Of Technical Requirements For Registration Of Pharmaceuticals For Human Use Draft Consensus Guideline For Elemental Impurities Q3D - Current Step 4 version dated 16 December 2014
· Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - EMA/CHMP/ CVMP/ SWP/169430/2012 - 20/11/2014
· ICH HARMONISED GUIDELINE ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK - M7(R1) - Current Step 4 version dated 31 March 2017
· Scientific Opinion on Exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC) EFSA Journal: 2012;10(7):2750 [103 pp.].
· Munro IC, Ford RA, Kennepohl E and Sprenger JG, 1996. Correlation of a structural class with No-Observed-effects-Level: a proposal for establishing a threshold of concern. Food Chem. Toxicol. 34, 829-867
· OECD guidance ENV/JM/MONO(2009)5 ("Guidance document for using the OECD (Q)SAR application toolbox to develop chemical categories according to the OECD guidance on grouping of chemicals")
· Scientific Committee on Health and Environmental Risks SCHER - Scientific Committee on Consumer Products SCCP - Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR "Risk assessment methodologies and approaches for genotoxic and carcinogenic substances" 2009
· OECD Guidelines for the Testing of Chemicals, Section 4 https://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testi…
· OECD eChemPortal http://www.webnet3.oecd.org/echemportal
· ECHA website http://echa.europa.eu
· ICH Safety Guidelines http://www.ich.org/products/guidelines/safety/article/safety-guidelines…
Periodo
Secondo semestre
Periodo
Secondo semestre
Modalità di valutazione
Esame
Giudizio di valutazione
voto verbalizzato in trentesimi
Docente/i
Ricevimento:
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