Safety Assessment of Xenobiotics and Biotechnological Products
Safety Assessment of Xenobiotics and Biotechnological Products
Course sheet
A.Y. 2025/2026
Master programme
LM-9 R - Biotecnologie mediche, veterinarie e farmaceutiche
The aim of the Master Course is to present provision of training program in risk assessment based on common European and international criteria, easily adoptable by institutions across Europe and worldwide and focusing on Risk Assessment methodology and procedure.
The Master provides the methodological background, knowledge and skills necessary to apply current methodologies and generate novel protocols, to acquire competence in problem-solving, to assess risks arising from production and use of chemicals and biotechnological products, with particular attention to the implementation of European Regulations through the integrated development of different areas including legislation, chemistry, toxicology and pharmacology, biotechnology and risk analysis. The graduates will have specific expertise in the areas of:
- community law, national and international legislation on chemicals, risk and safety;
- toxic and eco-toxic properties of chemicals and biotechnological products;
- methods and procedures for the characterization of chemical substances and biotechnological products;
- computational techniques for the estimation of the chemical and toxicological properties of substances;
- procedures for registration of chemicals under various European regulations;
- evaluation of risks inherent to the production and use of chemicals and biotechnological products;
- evaluation of new materials such as those produced by nanotechnologies and new processes;
- strategies of synthesis and production of alternatives to the toxic and/or eco-friendly;
- basis on risk perception and risk communication.
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. To this end, the Master degree in "Safety Assessment of Xenobiotics and Biotechnological Products" (SAXBi) has been certified (the first one in Europe), according to the Standard UNI EN 16736 and to the AICQ SICEV Regulation RG 06-1, that well define the formation for risk assessors.
The Master level "Safety assessment of xenobiotics and biotechnological products" (SAXBi) is equivalent to the second- level higher education award that 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 will meet those specific to the second Dublin descriptor.
The Master provides the methodological background, knowledge and skills necessary to apply current methodologies and generate novel protocols, to acquire competence in problem-solving, to assess risks arising from production and use of chemicals and biotechnological products, with particular attention to the implementation of European Regulations through the integrated development of different areas including legislation, chemistry, toxicology and pharmacology, biotechnology and risk analysis. The graduates will have specific expertise in the areas of:
- community law, national and international legislation on chemicals, risk and safety;
- toxic and eco-toxic properties of chemicals and biotechnological products;
- methods and procedures for the characterization of chemical substances and biotechnological products;
- computational techniques for the estimation of the chemical and toxicological properties of substances;
- procedures for registration of chemicals under various European regulations;
- evaluation of risks inherent to the production and use of chemicals and biotechnological products;
- evaluation of new materials such as those produced by nanotechnologies and new processes;
- strategies of synthesis and production of alternatives to the toxic and/or eco-friendly;
- basis on risk perception and risk communication.
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. To this end, the Master degree in "Safety Assessment of Xenobiotics and Biotechnological Products" (SAXBi) has been certified (the first one in Europe), according to the Standard UNI EN 16736 and to the AICQ SICEV Regulation RG 06-1, that well define the formation for risk assessors.
The Master level "Safety assessment of xenobiotics and biotechnological products" (SAXBi) is equivalent to the second- level higher education award that 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 will meet those specific to the second Dublin descriptor.
SAXBI offers various career opportunities for graduates, with roles in research, safety evaluation, production, and quality certification. These positions span both public and private sectors and involve tasks such as designing scientific experiments, analyzing data, and ensuring regulatory compliance. More specifically:
Research roles are available in public and private research institutions. These positions require skills in experimental design, data analysis, and scientific communication, as well as knowledge of safety regulations for chemical and biological products. Specific employers include universities, the Istituto Superiore di Sanità, and various governmental agencies.
Safety evaluation roles involve gathering toxicological data, assessing risks, and establishing health-based guidance values. These roles require critical thinking, knowledge of safety regulations, and the ability to work in teams. Employment opportunities exist in the biotechnology, pharmaceutical, diagnostic, food, cosmetic, and chemical industries.
Production roles encompass production management, quality control, and formulation development. These positions require managerial and planning skills, as well as knowledge of safety regulations. The same industries that employ safety evaluators also employ production specialists.
Quality certification roles involve verifying quality management systems, analyzing company processes, and defining work procedures that comply with regulations. This requires knowledge of safety regulations and the ability to interface with various professionals. Opportunities are available in consulting firms and various industries.
The resultant job profiles will be available for recruitment in:
- 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;
- researcher at public and private research institutions;
- researcher in industry (research and development sector); - risk assessor in public and private organizations;
- quality certifier.
Research roles are available in public and private research institutions. These positions require skills in experimental design, data analysis, and scientific communication, as well as knowledge of safety regulations for chemical and biological products. Specific employers include universities, the Istituto Superiore di Sanità, and various governmental agencies.
Safety evaluation roles involve gathering toxicological data, assessing risks, and establishing health-based guidance values. These roles require critical thinking, knowledge of safety regulations, and the ability to work in teams. Employment opportunities exist in the biotechnology, pharmaceutical, diagnostic, food, cosmetic, and chemical industries.
Production roles encompass production management, quality control, and formulation development. These positions require managerial and planning skills, as well as knowledge of safety regulations. The same industries that employ safety evaluators also employ production specialists.
Quality certification roles involve verifying quality management systems, analyzing company processes, and defining work procedures that comply with regulations. This requires knowledge of safety regulations and the ability to interface with various professionals. Opportunities are available in consulting firms and various industries.
The resultant job profiles will be available for recruitment in:
- 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;
- researcher at public and private research institutions;
- researcher in industry (research and development sector); - risk assessor in public and private organizations;
- quality certifier.
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:
- carry out the thesis.
Each student is followed by a tutor identified within the Course. The url https://www.unimi.it/en/node/12879/ 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 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 final 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.
- carry out the thesis.
Each student is followed by a tutor identified within the Course. The url https://www.unimi.it/en/node/12879/ 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 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 final 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.
Mandatory to the labs, recommended to the courses.
Students who are working
If the student is enrolled in working activities in laboratories in which techniques that are subject of the teaching laboratories are used, he/she is entitled of a partial/total exemption from laboratory attendance.
To take advantage of such concession, the student has to present to the Secretariat of the Teaching Committee copy of the job contract and timetable at the beginning of each academic year.
Alternatively, the students who are working are entitled to enroll as part-time students (see below).
Part-time students
In agreement with the University of Milan rules, students who cannot attend classes with academic continuity and take exams within the regular duration of the course, can be granted the possibility to follow a specific path based on the particular situation and can be enrolled as part-time students.
For further information, please visit the website https://www.unimi.it/en/node/113/
Students who are working
If the student is enrolled in working activities in laboratories in which techniques that are subject of the teaching laboratories are used, he/she is entitled of a partial/total exemption from laboratory attendance.
To take advantage of such concession, the student has to present to the Secretariat of the Teaching Committee copy of the job contract and timetable at the beginning of each academic year.
Alternatively, the students who are working are entitled to enroll as part-time students (see below).
Part-time students
In agreement with the University of Milan rules, students who cannot attend classes with academic continuity and take exams within the regular duration of the course, can be granted the possibility to follow a specific path based on the particular situation and can be enrolled as part-time students.
For further information, please visit the website https://www.unimi.it/en/node/113/
Enrolment
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 classes L-2 or L-29;
- 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 31st of October of the same year can also apply for admission to the Master in SAXBi, on the understanding that enrolment will only be finalised once the required qualification has been obtained.
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 classes L-2 or L-29;
- 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 31st of October of the same year can also apply for admission to the Master in SAXBi, on the understanding that enrolment will only be finalised once the required qualification has been obtained.
Admission
Application for admission: from 22/01/2025 to 31/07/2025
Application for matriculation: from 02/04/2025 to 30/11/2025
Attachments and documents
Online services
Learn more:
Programme description and courses list
year
| Courses or activities | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Compulsory | ||||
| Development Biology and Differentiation | 6 | 56 | English | BIO/13 |
First semester
| Courses or activities | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Compulsory | ||||
| 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 |
| Organ Physiopathology and Histopathology | 10 | 96 | English | BIO/09 MED/04 VET/03 |
| - Lab of Comparative Histopathology | 3 | |||
| - Organ Physiology and Pathology | 7 | |||
Second semester
| Courses or activities | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Compulsory | ||||
| Bioremediation | 7 | 88 | English | BIO/13 BIO/19 |
| Biotechnology and Pharmacotoxicology | 10 | 88 | English | BIO/14 |
| Regulatory Aspects in Toxicology | 6 | 48 | English | CHIM/09 IUS/14 |
be activated by the A.Y. 2026/2027
year
| Courses or activities | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Compulsory | ||||
| Quantitative Chemical Structure and Activity Relationship | 10 | 88 | English | BIO/10 BIO/14 |
| - In Silico Methods in Toxicology | 5 | |||
| - Structural Bioinformatics | 5 | |||
First semester
| Courses or activities | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Compulsory | ||||
| Databases and Exposure Scenarios | 6 | 48 | English | INF/01 MED/01 |
| System Toxicity and Risk Assessment | 7 | 64 | English | BIO/14 |
Second semester
| Courses or activities | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Compulsory | ||||
| 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 | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Optional | ||||
| 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 | Max ECTS | Total hours | Language | SSD |
|---|---|---|---|---|
| Optional | ||||
| Additional Language Skills: Italian (3 ECTS) | 3 | 0 | Italian | |
| Other Training Activities | 3 | 0 | English | |
| Compulsory | ||||
| Thesis | 29 | 0 | English | |
Study plan rules
- STUDENTS MUST CHOOSE AN OPTIONAL COURSE OF 8 ETCS.
These will be freely chosen among all courses provided by the University of Milan if the are compatible with the educational project, after consulting the Study Programme Committee. As an alternative, the student can also choose the Laboratory of Risk assessment 8 ETCS. This laboratory aims to deepen the theoretical and practical aspects of the research topic of the thesis and it will be agreed with the thesis tutor.
In addition, activities included in the University project for the development of soft skills can be chosen. https://www.unimi.it/en/study/bachelor-and-master-study/following-your-programme-study/soft-skills
These will be freely chosen among all courses provided by the University of Milan if the are compatible with the educational project, after consulting the Study Programme Committee. As an alternative, the student can also choose the Laboratory of Risk assessment 8 ETCS. This laboratory aims to deepen the theoretical and practical aspects of the research topic of the thesis and it will be agreed with the thesis tutor.
In addition, activities included in the University project for the development of soft skills can be chosen. https://www.unimi.it/en/study/bachelor-and-master-study/following-your-programme-study/soft-skills
| Courses or activities | Max ECTS | Total hours | Language | Lesson period | SSD |
|---|---|---|---|---|---|
| Laboratory of Risk Assessment | 8 | 0 | English | Open sessions |
- TO OBTAIN THE DEGREE, STUDENTS HAVE TO ACQUIRE AN ADDITIONAL 3 CREDITS (OTHER ACTIVITIES).
More information in the "Study plan definition and submission for approval" and in "Language and Computer skills" above.
More information in the "Study plan definition and submission for approval" and in "Language and Computer skills" above.
| Courses or activities | Max ECTS | Total hours | Language | Lesson period | SSD |
|---|---|---|---|---|---|
| Additional Language Skills: Italian (3 ECTS) | 3 | 0 | Italian | Open sessions | |
| Other Training Activities | 3 | 0 | English | Open sessions |
Learn more
Location
Milano
Course locations
Città Studi teaching facilities
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.
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
Città Studi teaching facilities
Laboratory activities are held in the labs of the School of Pharmacy, according to the timetable of the courses of Università degli Studi di Milano.
Laboratory activities are held in the labs of the School 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
Internship tutor
Master's degree admission tutor
Quality Assurance Delegate
Reference structures
Contacts
- Student Office of the Department of Pharmacological and Biomolecular Sciences - Dr. Sara Cosentino
Via Balzaretti, 9 Milano
[email protected]
+3902 5031 8231 - Suggestions to improve
[email protected] - Student Desks
Via Celoria 18, Milano
https://www.unimi.it/en/node/359
+3902 5032 5032
https://www.unimi.it/en/node/360 - Enrolment and Admission
https://www.unimi.it/en/study/enrolment - Contact
[email protected]
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).
Learn more
Guidance:
Admission, ranking and enrolment