Safety Assessment of Xenobiotics and Biotechnological Products
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a dataset collected by the EU Commission in June-September 2018
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Owner/Developer: University of Milan (SAXBi)
The industrial revolution has resulted in a profound and irreversible transformation that starts from the productive system to involve the economic as the entire social system. At the base of the phenomenon that has allowed the development of modern technology are the great discoveries of modern chemistry.
This has resulted in the need to regulate the complex world of chemicals both as regards their use and, above all, their safety. While the pharmaceutical field has developed in the last two decade a solid frame of rules and legislation aimed at limiting undesired effect of drugs, the rapid evolution of the productive system has not been followed by the generation of professionals with the competence and skills necessary to ensure the efficient and continuous monitoring of the environment and food chain.
As a result, the need to train professionals who can fit authoritatively in the complex process of risk assessment and possibly also in its management is imperative not only in the national, but also in the international scenario.
The recent implementation of regulatory frameworks for chemicals, plant protection products, biocides, pharmaceuticals, food contaminants, and cosmetics by the European Commission have resulted in a demand for trained health risk assessors across Europe. Not only are more trained professionals needed to work in regulatory affairs such as European agencies and national authorities, but also industry, research and the academic setting need such professionals.
This issue has become even more relevant in view of the activity of the agencies such the European Food Safety Authority (EFSA) and European Chemical Agency (ECHA) and the application of the new European regulations (for examples, REACH, Regulation (EC) No. 1223/2009 on cosmetic products, Regulation 1107/2009 on pesticides, etc.), which requires authorities and private companies to collect, to select and to correctly evaluate the data of effect and exposure for a large number of chemicals, to be carried out in the next decade.
Today, only a limited number of training courses specifically in human health risk assessment are available in Europe as shown from data collected by the University of Milan in a EU-sponsored market survey “Mapping existing courses relevant to risk assessment in Europe) and although some basic training in health risk assessment is part of most toxicology university programs, the preparation is often not enough to provide excellent candidates to become EUROTOX European Registered Toxicologists (ERTs).
Hands-on training, Lecture
To be admitted to a 2nd course/level degree course, a 1st level degree or a suitable equivalent foreign qualification is required (see below for details).
Legislative aspects, Computational methods
Full coverage (a dedicated course)
|Details on the topic or technology covered:||
1 year - semester I
Development biology and Differentiation
Functional, metabolic and Epigenetic biochemistry
Methods of analysis of chemicals in water, air, biological fluids, tissues, food
- Module: Methods of analysis of chemicals
- Module: Physical-chemical characterization, identity
Organ physiopathology and histopathology
- Module: Organ physiology and pathology
- Module: Lab of comparative histopathology
1 year - semester II
- Module: Environmental microbiology and Biotechnological remediation
- Module: Laboratory of cell biology
Biotechnology and pharmacotoxicology
- Module: Biotechnology and pharmacology
- Module: Genotoxicology, cancerogenicity, reproductive and developmental toxicity
Regulatory aspects in toxicology
- Module: Regulatory aspects of medicaments, medical devices and health products
- Module: Legislation in European Union
2nd year - semester I
Data base and Exposure scenarios
- Module: Informatics and Data Base
- Module: Statistics applied to epidemiology
Quantitative chemical structure and activity relationship
- Module: Methods of analysis applied to water, air, biological fluids,
tissues, food and in silico methods in toxicology
- Module: Structural bioinformatics
System toxicity and risk assessment
- Module: Risk assessment
- Module: System toxicity
2nd year- semester II
Pharmacogenetics and Epigenetics in toxicology
Other training activities
The aim of this master course is to provide specific knowledge in the analysis and assessment of risk, taking into account the European regulations. In addition, the ambition of the course is to provide the students with a multidisciplinary background sufficient to initiate research on the novel methodologies to be applied in the field of risk assessment. It is believed that the professional profiles formed will find employment in the European Institutions and Agencies dealing with the protection of health of consumer and the environment, as well as in companies operating in the chemical, agrochemical, pharmaceutical and food field.
As mentioned in the program of activity of ECHA “In the evaluation of dossiers ECHA produces scientific judgments. These judgments must be based on scientific principles accurate and require well-trained and competent experts. A number of scientific disciplines, such as toxicology, chemistry, epidemiology, occupational hygiene, environmental fate and effects on the environment, exposure assessment and characterization and risk management, must come to comprehensive evaluation results from the scientific point of view.”
The proposal aims to provide 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 and national 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.
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