Safety Assessment of Xenobiotics and Biotechnological Products

Dettaglio: occhio che guarda attraverso un microscopio
Safety Assessment of Xenobiotics and Biotechnological Products
Course sheet
A.Y. 2021/2022
Master programme
LM-9 - Pharmaceutical, veterinary and medical biotechnologies
Master programme
Open with entry requirements examination
Course location
The purpose is to create a new Master level, "Risk assessment of xenobiotics and biotechnological products (RA-XBP)" equivalent to the second-level higher education award that it refers to the second cycle in the Qualifications Framework of the European Higher Education Area (EHEA), designed by the Bologna Accords (1999) which refers to level 7 of the European Union's European Qualifications Framework. The degree requires 120 European Credit Transfer System (ECTS), and the expected learning outcomes particularly will meet those specific to the second Dublin descriptor. The aim is to present provision of training program in risk assessment based on common European criteria, easily adoptable by institutions across Europe and focusing on Risk Assessment methodology and procedure. The project focuses on understanding the profile and training requirements of risk assessors in order to design a degree covering a range of disciplines in risk assessment and providing a model to establish a recognition of risk assessors in accordance to a well-defined and properly acknowledged training standard that will be available and adopted in 2015 in all European Countries by the Committee for Standardization CEN member states (CEN TC/416).
The professional profiles generated will be employed by:
- public administration for the control, implementation and management of human health and environmental protection
- Industry Associations (Food, Cosmetics, Pharma, Chemicals)
- Pharma Companies in the sector of drug development
- Biotech Companies
- Contract Research Organization for the drug toxicity testing
- Food and Chemical Companies in Quality Control divisions
- Bioremediation Companies
- Innovative energy plants
- Public and Private Companies for the implementation and application of appropriate RA procedures
- Private sectors as consultants for RA of chemicals, food contaminants, water and air pollutants.
- Public and Private Research Institutions
- Universities and secondary schools

Employment statistics (Almalaurea)
Thanks to mobility Erasmus programs and other Mobility opportunities, the Master Course in SAXBi offers its students the opportunity to spend periods of training abroad. The Programs also offer the opportunity to play an internship abroad at companies, universities or other organizations. Universities and Institutions partners involved in these programs offer the possibility to engage in a wide range of areas. In the mobility period, the student can:
- continue their studies by attending courses and the respective exams;
- carry out the thesis.
Each student is followed by a tutor identified within the Course.… lists all the information related to the fields of study and training opportunities offered by the host locations. Procedure for the recognition of study periods abroad: each student must propose a Learning Agreement regarding training activities that lead to the recognition of a number of credits adequate to the period spent abroad.
The period of study abroad will be recognized as valid after obtaining at least 70% of the credits specified in the learning agreement, while the activity of the thesis or internship will be valid only after acquisition of all credits. For students who have accomplished satisfactorily the training program, there are appropriate incentives, proposed by the teacher in charge, will be paid by the Faculty in the diploma achievement session. It provides additional points to the degree mark varying from a minimum of 1 to a maximum of 3 points depending on the duration of the study period, the amount of credits attained, and the overall results obtained by the student
Admission Requirements
To be admitted to a 2nd course/level degree course, a 1st level degree or a suitable equivalent foreign qualification is required (see also the "Admission criteria" section).

Access to the Master in "Safety Assessment of Xenobiotics and Biotechnological Products" (SAXBi) is open to:
- graduates with Italian degree (ex. DM 270/04 or equivalent ex. DM 509/99) in the areas L2 or L29;
- graduates from areas other than the above listed, provided they have earned the following credits:
- at least 9 credits (ECTS) in disciplines of CHIM/01, CHIM/03 or CHIM/06 (analytical chemistry; general and inorganic chemistry; organic chemistry);
- at least 5 credits in disciplines BIO/09 (physiology);
- at least 12 credits in disciplines BIO/10, BIO/11 or BIO/13 (biochemistry; molecular biology; applied biology);
- at least 6 credits in disciplines BIO/14 (pharmacology/toxicology);
Students with foreign qualification recognised as equivalent may access to the Master in SAXBi if they can demonstrate background knowledge and skills in biology, chemistry, biochemistry, pharmacology, toxicology and physiology, equivalent to those listed above. A committee of teachers appointed by the Board of Faculty will check the presence of these requirements.

Knowledge Assessment
Students meeting the above minimum requirements are invited to an interview for admission (in English) with the Commission for Admittance to the Master, composed by teaching members appointed by the Teaching Board. The interview, done remotely via electronic devices if necessary, is aimed at verifying the above mentioned skills and the knowledge of the English Language equivalent to B2 level.

Students who have not yet graduated but who expect to graduate by December 2021 can also apply for admission to the Master in SAXBi.

Interviews of applicants will be held according to a calendar proposed individually to each applicant.
The committee evaluates the candidate on a 100-point scale:
-up to 25/100 will be given for the graduation mark
-up to 25/100 for the curriculum (free courses, others...)
-up to 50/100 for the interview
The minimum requirement for admission is 60/100.


Application for admission: from 12/03/2021 to 27/08/2021

Application for matriculation: from 01/04/2021 to 15/01/2022

Please note

Admitted students who have already graduated must enroll by 30 September 2021, while those who will achieve the qualification or requirements set by 31 December 2021 must enroll by 15 January 2022.

Programme description and courses list
First semester
Courses or activities ECTS Total hours Language SSD
Development Biology and Differentiation 6 56 English BIO/13
Functional, Metabolic and Epigenetic Biochemistry 6 48 English BIO/10
Methods of analysis of chemicals in water, air, biological fluids, tissues, food 6 48 English CHIM/01 CHIM/06
- Methods of analysis of chemicals3
- Physical-chemical characterization, identity3
Organ Physiopathology and Histopathology 10 96 English BIO/09 MED/04 VET/03
- Lab of Comparative Histopathology3
- Organ Physiology and Pathology7
Second semester
Courses or activities ECTS Total hours Language SSD
Bioremediation 7 88 English BIO/13 BIO/19
- Environmental Microbiology and Biotechnological Remediation3
- Laboratory of Cell Biology4
Biotechnology and Pharmacotoxicology 10 88 English BIO/14
- Biotechnology and Pharmacology5
- Genotoxicology, Cancerogenicity, Immunotoxicology, Reproductive and Developmental Toxicity5
Regulatory Aspects in toxicology 6 48 English CHIM/09 IUS/14
- Legislation in European Union3
- Regulatory Aspects of Medicaments, Medical Devices and Health products3
Courses or activities ECTS Total hours Language SSD
Quantitative Chemical Structure and activity relationship 10 88 English BIO/10 CHIM/08
- In Silico Methods in Toxicology5
- Structural bioinformatics5
First semester
Courses or activities ECTS Total hours Language SSD
Databases and Exposure scenarios 6 48 English INF/01 SECS-S/01
- Informatics and Database3
- Statistics applied to Epidemiology3
System Toxicity and Risk Assessment 7 64 English BIO/14
- Risk Assessment4
- System Toxicity3
Second semester
Courses or activities ECTS Total hours Language SSD
Pharmacogenetics and Epigenetics in Toxicology 6 48 English BIO/14
Open sessions
There are no specific sessions for these activities (e.g. open online courses).
Courses or activities ECTS Total hours Language SSD
Laboratory of Risk assessment 8 0 English
Conclusive activities
There are no specific sessions for these activities (e.g. open online courses).
Courses or activities ECTS Total hours Language SSD
Other training activities 3 0 English
Thesis 29 0 English
Study plan rules
- Students have to choose optional course for 8 credits.
Courses or activities ECTS Total hours Language Lesson period SSD
Laboratory of Risk assessment 8 0 English Open sessions
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Course locations
Teaching block Via Golgi, 19 - 20133 MILAN
Lectures are held in the classrooms indicated in the timetable of the courses of Università degli Studi di Milano.
All the classrooms are accessible to students with disabilities.
Laboratory locations
Teaching block Via Golgi, 19 - 20133 MILAN
Laboratory activities are held in the labs of the Faculty of Pharmacy, according to the timetable of the courses of Università degli Studi di Milano.
Head of study programme
Academic guidance tutor
Erasmus and international mobility tutor 
Master's degree admission tutor
Quality Assurance Delegate

The tuition fees for students enrolled in Bachelor's, Master's and single-cycle degree programmes are divided into two instalments with different calculation methods and payment schedules:

  • The amount of the first instalment is the same for all students
  • The amount of the second instalment varies according to the ISEE University value, the degree programme and the student status (on track / off track for one year or off track for more than a year) 
  • An additional fee is due for online programmes

The University also offers:

  • Concessions for students meeting high merit requirements
  • Diversified tuition fees according to the student's home country for international students with assets/income abroad
  • Concessions for international students with refugee status

Scholarships and benefits

The University provides a range of financial benefits to students meeting special requirements (merit, financial or personal conditions, international students).

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