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INTELLECTUAL OUTPUT O1 Syllabus on Toxicology moodle.toxoer.com Programa Erasmus+ Action KA2. Ref. 2015-1-ES01-KA203-015957 Cooperation for Innovation and the Exchange of Good Practice. Strategic Partnerships for Higher Education.

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Page 1: INTELLECTUAL OUTPUT O1 Syllabus on Toxicology · 2017-07-27 · INTELLECTUAL OUTPUT O1 Syllabus on Toxicology moodle.toxoer.com Programa Erasmus+ Action KA2. Ref. 2015-1-ES01-KA203-015957

INTELLECTUAL OUTPUT O1

Syllabus on Toxicology

moodle.toxoer.com

Programa Erasmus+

Action KA2. Ref. 2015-1-ES01-KA203-015957

Cooperation for Innovation and the Exchange of Good Practice. Strategic Partnerships for Higher Education.

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Table of Contents

- Creative Commons Licence……………………………………. Page 3

- Levels of Access…………………………………………………. Page 4

- Map of learning contents……………………………………….. Page 5

- Description of activities (by each Topic)…………………….. Page 7

- Module description………………………………………………. Page 8

- Topic description………………………………………………… Page 29

- List of authors……………………………………………………. Page 73

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Creative Commons Licence

Our learning materials will be licenced with one of the following open licences

(please remember that without these licences we can not intend our materials as Open Educational Resources)

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Levels of access

1. Free Level (OERs open to the world and different targets: this level does not release a certificate of attendance nor

credits)

2. Certificate of attendance (this certificate does NOT have a LEGAL VALUE)

3. Credits for recognition

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Maps of learning contents

Module Topics ECTS

[35 ECTS Total] Responsible partner

MODULE 1: General

Concepts

1.1. Glossary (terms and concepts) 1 ECTS

[1 ECTS Total]

UPorto

MODULE 2: Pharmaco-

Toxicokinetics

2.1. ADMET, Membrane and Transport Mechanisms

2.2. ABC Transporters, BBB Barrier

2.3. Absortion, Distribution, Excretion

2.4. Xenobiotic Metabolism

1 ECTS

1 ECTS

2 ECTS

2 ECTS

[6 ECTS Total]

UPorto

UPorto

UPorto

UPorto

MODULE 3: Principal

Groups of Xenobiotics

3.1. Prescription Drugs

3.2. Drugs of Abuse

2 ECTS

2 ECTS

[4 ECTS Total]

UniBo

UniBo

MODULE 4: Environmental

Pollutants

4.1. Gaseous Pollutants

4.2. Heavy Metals

4.3. Persistent Organic Pollutants

4.4. Pesticides I

4.5. Pesticides II

1 ECTS

1 ECTS

1 ECTS

2 ECTS

2 ECTS

[7 ECTS Total]

UTBv

CUNI

UTBv

SRTI-BAS

SRTI-BAS

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MODULE 5: Target Organ

Toxicity and Biomarkers

5.1. Cardiovascular

5.2. Pulmonary

5.3. Renal

5.4. Liver

5.5. Nervous System

2 ECTS

1 ECTS

2 ECTS

2 ECTS

1 ECTS

[8 ECTS Total]

CUNI

CUNI

USAL

UPorto

USAL

MODULE 6: Environmental

Toxicology 6.1. European and National Regulations Related to

Environmental Quality

6.2. Control of Emissions from Anthropogenic Activities and

Safety

6.3. Introduction to the Environmental Quality Monitoring

System

6.4. Monitoring the Environmental Quality - Air, Water, Soil

2 ECTS

2 ECTS

1 ECTS

2 ECTS

[7 ECTS Total]

UTBv and all partners

XAMK

UTBv

UTBv

MODULE 7: Patents and

Patent Application

7.1. European legislation, Patentability, Structure of

patents, Forensic applications of patents 2 ECTS

[2 ECTS Total]

UniBo

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Description of activities (by each Topic)

ECTS

1 2

Content/activity Introduction test 1 1

Introduction video (3 minutes) 1 1

Multimedia learning content (number of 10-minutes videos or commented slides)

3 6

Text oriented content: to deepen the in the topic (i.e. papers, digital

text contents created by partners book chapters …)

(hours of reading)

4 8

Evaluation Self evaluation (number of self evaluation quiz)

2 4

Final test 1 1

Certification (release of certificate of participation

without legal value)

Hours 21 42

Final evaluation 1 1

Tutoring (hours) 3 6

Accreditation Total hours (conventional) 28 56

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Module description

Module 1: General Concepts

Name of the module 1: General Concepts

Date of release / last update Created 13-03-2016, changed at 22-04-2016

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Renata Silva (UPorto) Diana Silva (UPorto) Margarida Araújo (UPorto) Maria João Valente (UPorto)

Short descriptions (goals, learning objectives,

contents, activities → if/when expected, evaluation →

if/when expected)

This module aims to define Toxicology and its main areas (Mechanistic, Descriptive and Regulatory). The sub-disciplines Forensic, Clinical, Environmental, Occupational Toxicology as well as Toxicogenomics will be also presented in video. Concepts of toxic, toxin, xenobiotics, types of intoxications (acute/chronic, accidental/intentional), types of xenobiotic interactions (additive, synergic, potentiation and antagonism), tolerance, maximum effect and potency will be explain.

Intended learning outcomes The main Learning Objectives of this module are: ● To understand the main and overall concepts related to the Toxicology;

● To share a basic common acknowledgment between students, that will be important to

understand the following modules;

● To create the learning environment of the course that will help the students to finish it

with success. Learning Outcomes: at the end of this module, the learner should be able to:

● Recognize the main denominations that are common in Toxicology;

● Explain the main areas in Toxicology field;

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● Define concepts as toxic, toxin, xenobiotics, types of intoxications (acute/chronic,

accidental/intentional), types of xenobiotic interactions (additive, synergic, potentiation

and antagonism), tolerance, maximum effect and potency;

● Interpret the different types of xenobiotic interactions and the tolerance phenomenon;

● Differentiate the parameters of the biological effects of xenobiotics: maximum effect

and potency.

Module structures (Topics) 1.1- Glossary (terms and concepts) (1ECTS)

● Mechanistic, Descriptive and Regulatory Toxicology ● Forensic, Clinical, Environmental, Occupational Toxicology, Toxicogenomics ● Xenobiotics, toxic, toxin ● Types of intoxications: acute/chronic, accidental/intentional ● Additive, synergic, potentiation and antagonism ● Tolerance ● Maximum effect and potency

Estimated workload (total of hours to complete the module)

1 ECTS: 28 hours

Audience (possible targets) Students (University, PhD or Master) of degrees: - Pharmacy

- Medicine

- Nursing

- Veterinary medicine

- Biology

- Environmental Engineering

- Forensic sciences

Students of Vocational training

- Pharmacy assistant

- Nursing assistant

- Veterinary assistant

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- Laboratory technicians

Professionals in fields related to toxicology

- Pharmacists

- Occupational medicine professionals

- Forensics

- Supervisory bodies

- Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an English or native language version of each author will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Module 2: Pharmaco-Toxicokinetics

Name of the module 2: Pharmaco-Toxicokinetics

Date of release / last update Created 13-03-2016, changed at 22-04-2016

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Renata Silva (UPorto) Diana Silva (UPorto) Margarida Araújo (UPorto) Maria João Valente (UPorto)

Short descriptions (goals, learning objectives,

contents, activities → if/when expected, evaluation →

if/when expected)

This module aim to describe the phenomena of pharmaco-toxicokinetic and contextualize the pharmacological and toxicological consequences related to the absorption, distribution, metabolism, excretion and transport (ADMET) of xenobiotics (drugs and toxic compounds). The students will contact with movies showing the ADMET processes as well as research data that will allow them to interpret the risks associated with xenobiotic exposure related to their disposition in the organism.

Intended learning outcomes The main Learning Objectives of this module are: ● To understand the main ADMET related processes, namely the mechanism by which

the xenobiotics pass through the membranes, as well as the main pathways and

barriers concerning absorption, distribution and excretion of xenobiotics;

● To know the main metabolic processes, highlighting the classic mechanisms of

bioactivation;

● To recognize important ADMET phenomena related to the variability of biological and

genetic aspects, which modulate pharma and toxicological effects of xenobiotics.

Learning Outcomes: at the end of this module, the learner should be able to:

● Concerning mechanism by which xenobiotics pass through membranes: o Differentiate the known transport mechanisms;

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o Describe the main chemical characteristics of xenobiotics that are favorable to their pass

through membranes;

o Predict the transport mechanism, considering the physical-chemical characteristics of the

xenobiotics;

o Relate the membrane transporters with phase 0 and 3 in cellular influx and efflux of

xenobiotics;

o Interpret the biological consequences of xenobiotics interactions at transport level

● Concerning main pathways and barriers related to absorption, distribution and

excretion of xenobiotics: o Explain the main pathways by which xenobiotics are absorbed, highlighting the

gastrointestinal, pulmonary and dermic routes;

o Predict the xenobiotic bioavailability and distribution, considering the route of exposure;

o Describe the main factors that modulate the distribution of xenobiotics (protein-binding,

tissue accumulation and organ protected barriers, as blood-brain-barrier and placenta);

o Compare the xenobiotics distribution in relation with their physical-chemical characteristics;

o Describe the main routes and mechanisms of xenobiotic elimination

o Interpret the xenobiotic interactions at excretion mechanisms

o Predict xenobiotic mechanism of excretion, considering its physical-chemical characteristics

● Concerning the xenobiotic metabolism: o Identify the main metabolic organs;

o Describe the different metabolic phases (Phase 1 and 2)

o Interpret the way by which Phase 0 and 3 modulate the metabolic processes

o Explain the phase I metabolism, namely the microsomal and the non-microssomal

enzymatic reactions, as well as types of reactions (oxidation, reduction, hydrolysis) and the main enzymes catalyzing these reaction;

o Illustrate the importance of Cytochrome P450 in xenobiotic metabolism, highlighting the

principal isoenzymes involved;

o Explain the phase II metabolism;

o Recognize the main bioactivation processes, namely reactions (e.g. oxidation, reduction,

glucuronidation); enzymes involved (e.g. Cytochrome P450, Peroxidases and Glucuronosyl transferases); chemical structures (e.g. epoxides, quinones, aromatic amines);

o Discriminate the detoxification/bioactivation pathways in metabolic profile of classic

xenobiotics in Toxicology.

● Concerning ADMET processes variability phenomena: o Relate the biological and genetic variability in ADMET processes with pharma and

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toxicological outcomes of xenobiotics.

Module structures (Topics) 2.1- ADMET, Membrane and Transport Mechanisms (1 ECTS) ● Main concepts: Absorption, distribution, metabolism, excretion and transport (ADMET)

● Chemical and Physical Membrane characteristics

● Xenobiotic transport mechanisms

○ Passive transport

○ Active transport

● Phase 0 and 3 in cellular influx and efflux of xenobiotics

● Xenobiotic interactions at transport level

● Biological and genetic variability in ADMET

2.2- ABC Transporters, BBB Barrier (1 ECTS) ● ADMET and Membrane Transporters

● Transporters at Blood-Brain-Barrier (BBB) and other tissues

● Xenobiotic interactions at transport level, Transporters variability and biological

consequences

2.3- Absorption, Distribution, Excretion of xenobiotics (2 ECTS)

● Toxicokinetics and main routes of xenobiotics absorption, distribution and excretion

● Factors that modulate the distribution of xenobiotics (protein-binding, tissue

accumulation)

● Main barriers concerning distribution (Blood-Brain-barrier and Placenta) 2.4- Xenobiotic Metabolism (2 ECTS)

● Phase 1 reactions

○ Oxidations, reductions and hydrolysis

○ Microsomal reactions (Cytochrome P450)

○ Non-microsomal reactions (Alcohol and Aldehyde dehydrogenase, Epoxide

Hydrolase and Esterases)

● Phase 2 reactions

○ Glucuronidation, sulfonation, acetylation, methylation and conjugation with

glutathione, amino-acids and CoA

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● Detoxification/bioactivation pathways (e.g. paracetamol, salicylates, benzo(a)pyrene,

aflatoxin B1)

Estimated workload (total of hours to complete the module)

6 ECTS: 168 hours

Audience (possible targets) Students (University, PhD or Master) of degrees: - Pharmacy

- Medicine

- Nursing

- Veterinary medicine

- Biology

- Environmental Engineering

- Forensic sciences

Students of Vocational training

- Pharmacy assistant

- Nursing assistant

- Veterinary assistant

- Laboratory technicians

Professionals in fields related to toxicology

- Pharmacists

- Occupational medicine professionals

- Forensics

- Supervisory bodies

- Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an English or native language version of each author will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Module 3: Principal Groups of Xenobiotics

Name of the module 3: Principal Groups of Xenobiotics

Date of release / last update 22 April 2016

Author/s Luca Ferrari (UniBo) Stefano Girotti (UniBo) Luigi Guerra (UniBo) Roberto Mandrioli (UniBo) Laura Mercolini (UniBo) Michele Protti (UniBo)

Short descriptions (goals, learning objectives,

contents, activities → if/when expected, evaluation →

if/when expected)

This module describes the main toxicological characteristics of prescription and abuse drugs, and their differences from legal and scientific points of view. Analytical methods for their qualitative and quantitative determination in different biological and non-biological matrices will be described and discussed. The most important aspects of regulations in the pharmaceutical sector will be provided and explained.

Intended learning outcomes At the end of this module, the learner should be able to: - describe the main sources and contents of regulations in the pharmaceutical sector;

- identify, understand and follow GLP and GMP;

- understand the difference between prescription drugs and abuse drugs;

- know and identify the most important toxicological effects of drugs;

- find, understand, evaluate and use scientific and official publications to analyze

different kinds of pharmaceutical and toxic substances;

- apply the information received to a forensic setting.

For each class of abuse and prescription drugs, the student should be able to:

- Cite and identify the main members of the class;

- Hypothesize one or more possible analytical strategies that could be suitable for most

drugs in the class;

- Search the literature and find relevant papers and guidelines for the sampling, sample

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pre-treatment and analysis of the drugs belonging to the class;

- Participate in, and contribute to, decisional processes and practical work related to

forensic and other highly regulated analytical fields;

- Actively participate in certification and accreditation procedures.

Module structures (Topics) 3.1 - Prescription drugs (2 ECTS)

● Toxicology

● Forensic analysis

● Case reports

● Pharmaceutical sector regulation: GLP, GMP, certification, accreditation, ICH, case

studies

3.2- Drugs of abuse (2 ECTS)

● Drug toxicology

● Forensic analysis

● Case reports

Estimated workload (total of hours to complete the module)

4 ECTS: 112 hours

Audience (possible targets) Students in the health professions, physicians, hygienists, chemists, pharmacists.

Available languages Basic language - English. Then translation into native languages of each author (Italian) and into the languages of of all involved countries ( Spanish, Portuguese, Czech, Romanian, Bulgarian, Finnish)

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Module 4: Environmental Pollutants

Name of the module 4: Environmental Pollutants

Date of release / last update Organized on 07.04.2016; Last update on 17.02.2017

Author/s Dana Perniu and Ileana Manciulea (UTBv) - Gaseous pollutants Marie Voprsalova (CUNI) - Heavy metals Ileana Manciulea and Lucia Dumitrescu (UTBv) - Persistent Organic Pollutants Lubomir Simeonov and Yordan Simeonov (SRTI) - Pesticides

Short descriptions (goals, learning objectives,

contents, activities → if/when expected, evaluation →

if/when expected)

The aim of this module is to describe the impact of some pollutants (gaseous pollutants, persistent organic pollutants, heavy metals and pesticides) on the human health, as well as on the environment

Intended learning outcomes Students will be able: ● to identify sources of toxic agents

● to explain the mechanism of action

● to interpret the fate of toxic agents in the organism

● to recommend the biological material for the laboratory determination

● to distinguish acute and chronic intoxications

● to compare the use of antidotes,chelating agents during intoxications

● to predict and estimate risks on the human health

Module structures (topics) 4.1- Gaseous pollutants (1 ECTS) ● Sources of gaseous pollutants in urban atmosphere ● Gaseous pollutants transport in urban atmosphere ● Indoor pollution

4.2- Heavy metals (1 ECTS)

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● Metals of a great public health significance - Cadmium

- Lead

- Mercury

- Arsenic (including arsine)

● Other metals with multiple effects

- Chromium

- Copper

- Nickel

- Zinc

- Aluminium

- Iron

4.3- Persistent Organic Pollutants (1 ECTS)

● Persistent Organic Pollutants - Introduction ● Short-chain chlorinated paraffins (SCCPs) ● Pentachlorophenol (PCP) ● Hexachlorocyclohexanes (HCHs) ● Polycyclic aromatic hydrocarbons (PAHs) ● Polychlorinated biphenyls (PCBs) ● Polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans (PCDD/ PCDF)

4.4- Pesticides I (2 ECTS)

● Historical Issues in the Pesticide Application and Related Pollution o Significance of the Pesticides; Application Areas

o Hazardous Pesticides

o Pollution of Environmental Media, Paths and Distribution

● Environmental Concerns, Ecotoxicology ● Human Health Concerns

o Vulnerable groups of population;

o Acute and Chronic Exposure to Pesticides;

o Adverse effects: Allergies, Hypersensitivity, Developmental and

Cancerogenic Effects, Damage to the Central and Peripheral Nervous

System, Reproductive Disorders, Disruption of the Hormonal and the

Endocrine Systems, etc.

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4.5- Pesticides II (2 ECTS)

o General Issues and Definitions

o Risk Assessment and Management

o Sampling and Analysis ( Planning, Procedures, Technologies)

o Technologies for Elimination and Destruction (Evaluation and Comparison)

o Conclusions and Recommendations

● International awareness rising and impact o Rachel Carson’s “Silent Spring”

o Review of International Agreements

o The Basel Convention

o The Rotterdam Convention

o The Stockholm Convention

o The “Dirty Dozen” of POPs

o Limits and Bans of Production and Application of Certain

POPs/Pesticides - Historical Overview and Contemporary Status

● Environmental Security

o Military Applications of POPs/Pesticides

o Transboundary Pollution

o Organic Arsenicals, Dioxin

o Agent Orange and Agent Blue

● Integrated Pest Control (IPC), Integrated Pest Management (IPM) ● Biological Pesticides, Advantages and drawbacks

● Pesticide Legislation and Registration

o General Approaches and Procedures

● Inventories o Pesticide Production, Import, Export, Lists of Producers, Companies,

Suppliers, Trade and Distribution, Packing and Labeling, Transport, Storage

and Disposal, Application

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o Personnel Training Requirements, Licensing

o Identification of responsible authorities for Pesticide Regulation and Laws

● International Organizations - WHO, FAO, UNEP, USEPA, IARC, etc. ● Specialised Websites on POPs/Pesticides ● Specialised Programs (PESTIDOC, PAN Pesticide, SAFEFOODNET, etc.). ● Bibliography ● Glossary

Estimated workload (total of hours to complete the module)

7 ECTS: 192 hours

Audience (possible targets) Mainly High Education Students and Doctoral Students in Environmental Sciences, Health Sciences (Medicine, Chemistry, etc.), Students in the health professions, physicians, hygienists

Available languages English as basic language, The other project partner languages in translation, subtitles, etc.

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Module 5: Target Organ Toxicity and Biomarkers

Name of the module 5: Target Organ Toxicity and Biomarkers

Date of release / last update Created 22-04-2016, changed at 22-02-2017

Author/s Ana Isabel Morales Martín (USAL) Marta Prieto Vicente (USAL) Laura Vicente Vicente (USAL) Moisés Pescador Garriel (USAL) Alfredo Ginés Casanova Paso (USAL) Mª Teresa Hernández Sánchez (USAL) Premysl Mladenka (CUNI) Jana Pourova (CUNI) Fernando Remião (UPORTO) Maria de Lourdes Bastos (UPORTO) Helena Carmo (UPORTO) Renata Silva (UPORTO) Diana Silva (UPORTO) Margarida Araújo (UPORTO) Maria João Valente (UPORTO)

Short descriptions (goals, learning objectives,

contents, activities → if/when expected, evaluation →

if/when expected)

This module aims to learn the adverse effects or pathological states caused by toxicants in specific organs of the body. For each organ, several aspects will be discussed: the main mechanisms involved in the toxicity, the main toxicants responsible for the damage and the currently used biomarkers which are able to specify the kind of damage and the place where is being produced.

Intended learning outcomes At the end of this module, the learner should be able to: - identify the organ and type(s) of damage brought by toxic agents.

- know the mechanisms of toxicity produced in each organ.

- differentiate the biomarkers able to detect the damage(s) in each organ.

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For each target organ of toxicity, the student should be familiar with:

- Important information about the structure and function of organs if relevant for

toxicologal aspects

- General patterns of organ toxicity including mechanisms of damage (if known)

- Consequences of organ toxic damage(s), in particular functional impairment

- Important biomarkers of organ toxicity (if known)

- Important consequences of organ toxicity affecting other tissues or systems (if they

exist)

- Examples of toxic substances that affect the target organ

Module structures (Topics) 5.1- Cardiovascular toxicity (2 ECTS)

Basic aspects of the heart physiology including the impact of the sympathetic and

parasympathetic nervous system

An overview of cardiovascular toxicity including the most important toxic agents and

main modalities of intoxications treatment

Markers of cardiovascular toxicity

5.2- Pulmonary toxicity (1 ECTS)

Human respiratory system anatomy, physiology and defence - basic aspects

Air-borne agents - general characteristics and the most important toxic gases, vapors

and fine particles

Blood-borne agents - general characteristics and the most important examples

5.3- Renal toxicity (2 ECTS)

● Renal system and sources of exposure to renal toxins

● Mechanisms of nephrotoxicity

● Kidney response to toxic injury

● Diagnosis and treatment of kidney damage

5.4- Liver toxicity (2 ECTS)

● Liver physiology

● Main mechanisms of liver injury by xenobiotics

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● Factors affecting xenobiotic hepatotoxicity

● Hepatotoxic xenobiotics (e.g. alcohol, paracetamol, carbon tetrachloride, aflatoxin B)

5.5- Nervous system toxicity (1 ECTS)

● Nervous system

● Toxic neuropathies

● Neurodegenerative diseases and toxicity

Estimated workload (total of hours to complete the module)

8 ECTS: 224 hours

Audience (possible targets) Students (University, PhD or Master) of degrees: - Pharmacy

- Medicine

- Nursing

- Veterinary medicine

- Biology

- Environmental Engineering

- Forensic sciences

Students of Vocational training

- Pharmacy assistant

- Nursing assistant

- Veterinary assistant

- Laboratory technicians

Professionals in fields related to toxicology

- Pharmacists

- Occupational medicine professionals

- Forensics

- Supervisory bodies

- Police forces

General audience interested in toxicology

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Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an English or native language version of each author will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Module 6: Environmental Toxicology

Name of the module 6: Environmental Toxicology

Date of release / last update Created 15-3-2016, last update 17.02.2017

Author/s Camelia Draghici (UTBv) Ileana Manciulea (UTBv) Lucia Dumitrescu (UTBv) Dana Perniu (UTBv) Cristina Rotaru Salca (UTBv) Merja Mäkelä (XAMK) Mirva Pilli-Sihvola (XAMK) Kim-Laura Kern (XAMK)

Short descriptions (goals, learning objectives,

contents, activities → if/when expected, evaluation →

if/when expected)

The goal of the module is to understand the correlation between the sources of toxic emissions and the assessment systems of emissions and immissions, according to personal and authoritative rights and duties related to toxic pollutants. The content and activities are discussed based on the pollutants’ flow: source – transport – targeted environmental components.

Intended learning outcomes Learning objectives: After learning this module, students will be able to

● understand the sources of toxic emissions

● evaluate the environmental impact of toxic compounds in emissions and immissions

● evaluate personal and authoritative rights and duties with toxic pollutants.

Learning outcomes: After learning this module, students will be able to

● describe and interpret the processes schemes generating anthropogenic toxic

emissions using schemes, process flow charts and diagrams

● compare the level of toxic pollutants evacuated in the environment, with the related

concentration limits, according to specific regulations

● assess the influence of the toxic compounds released on the public health

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● assess safety conditions and apply related safety regulations when dealing with toxic

substances.

Module structures (Topics) 6.1 European and National Regulations Related to Environmental Quality (2 ECTS) ● Establishing the European legislative framework and specific toxic pollutants ● National harmonization of EU legislation on toxic pollutants ● Legislative correlations

6.2 Control of Emissions from Anthropogenic Activities and Safety (2 ECTS)

● Sources of toxic emissions ● Measuring, monitoring and control of emissions ● Safety aspects

6.3 Introduction to the Environmental Quality Monitoring System (1 ECTS)

● Environmental monitoring scheme and related activities ● Environmental sampling and analytical measurements ● Environmental data processing and reporting

6.4 Monitoring the Environmental Quality - Air, Water, Soil (2 ECTS)

● Air quality monitoring ● Waters quality monitoring ● Soils quality monitoring

Estimated workload (total of hours to complete) 7 ECTS: 196 hours

Audience (possible targets) ● Bachelor, Master and Doctor students of energy and environmental technology

● Power plants, industry, agricultural and other operators, project and maintenance

engineers

● Authorities in energy and environmental sector

● Environmentally aware citizens

Available languages First in English by authors, then in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish by partners.

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Module 7: Patents and Patent Application

Name of the module 7: Patents and Patent Application

Date of release / last update 15 March 2016

Author/s Simone Mangini (UniBo)

Short descriptions (goals, learning objectives,

contents, activities → if/when expected, evaluation →

if/when expected)

This module aims to provide basic information about the patent system and when an invention can be patentable. Concepts about patentability will be dealt with and several examples about patents in the chemistry field will be provided. The enforcement of patent rights will be also discussed.

Intended learning outcomes Learning objectives: ● to understand the basic information about patent system

● to understand how to enforce the patent rights

● to evaluate how patents may be used

Learning outcomes: -After completing the learning of this module, students will be able to:

● recognize the basic requirements of patentability;

● recognize how the priority right works and can be used;

● identify matters that are non eligible for patent protection;

● apply the procedures for filing and prosecuting patent applications and of international

conventions such as the PCT and the EPC;

● recognize the importance of patents

● identify how patents may be used

Module structures (topics) 7.1- European legislation, Patentability, Structure of patents, Forensic applications of patents

(2 ECTS)

● Examples of patenting

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● Patentability

● Priority right

● Patents in the chemistry field

● The European Patent Convention (EPC)

● The Patent Cooperation Treaty (PCT)

● Importance of patenting

● Patent litigation

Estimated workload (total of hours to complete the module)

2 ECTS: 56 hours

Audience (possible targets) ● Bachelor, Master and PhD students in the life sciences field (e.g. chemistry, biotech,

pharmacy etc.)

● Managers of private and public companies that deal with innovation

● People interested in the field (a technical knowledge in life science would be

preferable)

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish

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Topic description

Module 1: General Concepts (1 ECTS)

Topic 1.1: Glossary (terms and conceps) (1 ECTS)

Name of the Topic Glossary (terms and conceps)

Date of release / last update 18 May 2016

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Félix Carvalho (UPorto)

Short descriptions This topic aims to define Toxicology and its main areas (Mechanistic, Descriptive and Regulatory). The sub-disciplines Forensic, Clinical, Environmental, Occupational Toxicology as well as Toxicogenomics will be also presented in video. Concepts of toxic, toxin, xenobiotics, types of intoxications (acute/chronic, accidental/intentional), types of xenobiotic interactions (additive, synergic, potentiation and antagonism), tolerance, maximum effect and potency will be explain.

Intended learning outcomes The main Learning Objectives of this topic are: ● To understand the main and overall concepts related to the Toxicology;

● To share a basic common acknowledgment between students, that will be

important to understand the following modules;

● To create the learning environment of the course that will help the students to

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finish it with success. Learning Outcomes: at the end of this topic, the learner should be able to:

● Recognize the main denominations that are common in Toxicology;

● Explain the main areas in Toxicology field;

● Define concepts as toxic, toxin, xenobiotics, types of intoxications

(acute/chronic, accidental/intentional), types of xenobiotic interactions

(additive, synergic, potentiation and antagonism), tolerance, maximum effect

and potency;

● Interpret the different types of xenobiotic interactions and the tolerance

phenomenon;

● Differentiate the parameters of the biological effects of xenobiotics:

maximum effect and potency.

Audience (possible targets) Students (University, PhD or Master) of degrees: ● Pharmacy

● Medicine

● Nursing

● Veterinary medicine

● Biology

● Environmental Engineering

● Forensic sciences

Students of Vocational training

● Pharmacy assistant

● Nursing assistant

● Veterinary assistant

● Laboratory technicians

Professionals in fields related to toxicology

● Pharmacists

● Occupational medicine professionals

● Forensics

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● Supervisory bodies

● Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Portuguese version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Module 2: Pharmaco-Toxicokinetics (6 ECTS)

Topic 2.1: ADMET, Membrane and Transport Mechanisms (1 ECTS)

Name of the Topic 2.1: ADMET, Membrane and Transport Mechanisms

Date of release / last update 18 May 2016

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Renata Silva (UPorto) Diana Silva (UPorto) Margarida Araújo (UPorto) Maria João Valente (UPorto)

Short descriptions This module aim to describe the phenomena of pharmaco-toxicokinetic and contextualize the pharmacological and toxicological consequences related to the absorption, distribution, metabolism, excretion and transport (ADMET) of xenobiotics (drugs and toxic compounds). The students will contact with movies showing the ADMET processes as well as research data that will allow them to interpret the risks associated with xenobiotic exposure related to their disposition in the organism.

Intended learning outcomes The main Learning Objectives of this module are: ● To understand the main ADMET related processes, namely the mechanism

by which the xenobiotics pass through the membranes, as well as the main

pathways and barriers concerning absorption, distribution and excretion of

xenobiotics.

Learning Outcomes: at the end of this module, the learner should be able to:

● Differentiate the known transport mechanisms;

● Describe the main chemical characteristics of xenobiotics that are favorable

to their pass through membranes;

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● Predict the transport mechanism, considering the physical-chemical

characteristics of the xenobiotics;

● Relate the membrane transporters with phase 0 and 3 in cellular influx and

efflux of xenobiotics;

● Interpret the biological consequences of xenobiotics interactions at

transport level

Audience (possible targets) Students (University, PhD or Master) of degrees: ● Pharmacy

● Medicine

● Nursing

● Veterinary medicine

● Biology

● Environmental Engineering

● Forensic sciences

Students of Vocational training

● Pharmacy assistant

● Nursing assistant

● Veterinary assistant

● Laboratory technicians

Professionals in fields related to toxicology

● Pharmacists

● Occupational medicine professionals

● Forensics

● Supervisory bodies

● Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Portuguese version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Topic 2.2: ABC Transporters, BBB Barrier (1 ECTS)

Name of the Topic 2.2: ABC Transporters, BBB Barrier

Date of release / last update 7 june 2017

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Félix Carvalho (UPorto)

Short descriptions This module aim to describe the role of membrane transporters and contextualize the pharmacological and toxicological consequences related to their presence in different tissues, namely in Blood-Brain-Barrier (BBB) and also in tubular cels, hepatocytes and enterocytes. The students will contact with movies showing the membrane transporters as well as research data that will allow them to interpret the risks associated with xenobiotic exposure related to their disposition in the organism.

Intended learning outcomes The main Learning Objectives of this module are: ● To understand the membrane transporters role in pharmaco-toxicokinetics

Learning Outcomes: at the end of this module, the learner should be able to:

● To Relate the membrane transporters with phase 0 and 3 in cellular influx and efflux of xenobiotics

● To predict the consequences of membrane transporters role at blood brain

barrier level, as well as in tubular cells, hepatocytes and enterocytes

● To Interpret the biological consequences of xenobiotics interactions at

transport level, as well as from polymorphysm phenomena

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Audience (possible targets) Students (University, PhD or Master) of degrees: ● Pharmacy

● Medicine

● Nursing

● Veterinary medicine

● Biology

● Environmental Engineering

● Forensic sciences

Students of Vocational training

● Pharmacy assistant

● Nursing assistant

● Veterinary assistant

● Laboratory technicians

Professionals in fields related to toxicology

● Pharmacists

● Occupational medicine professionals

● Forensics

● Supervisory bodies

● Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Portuguese version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Topic 2.3: Absorption, Distribution, Excretion (2 ECTS)

Name of the Topic 2.3: Absorption, Distribution, Excretion

Date of release / last update 18 may 2016

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Félix Carvalho (UPorto)

Short descriptions This module aim to describe the phenomena of pharmaco-toxicokinetic and contextualize the pharmacological and toxicological consequences related to the absorption, distribution, and excretion of xenobiotics (drugs and toxic compounds). The students will contact with movies showing the kinetic processes as well as research data that will allow them to interpret the risks associated with xenobiotic exposure related to their disposition in the organism.

Intended learning outcomes The main Learning Objectives of this module are: ● To understand the main ADMET related processes, namely the mechanism

by which the xenobiotics pass through the membranes, as well as the main

pathways and barriers concerning absorption, distribution and excretion of

xenobiotics

Learning Outcomes: at the end of this module, the learner should be able to:

● Explain the main pathways by which xenobiotics are absorbed,

highlighting the gastrointestinal, pulmonary and dermic routes;

● Predict the xenobiotic bioavailability and distribution, considering the

route of exposure;

● Describe the main factors that modulate the distribution of xenobiotics

(protein-binding, tissue accumulation and organ protected barriers, as

blood-brain-barrier and placenta);

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● Compare the xenobiotics distribution in relation with their physical-

chemical characteristics;

● Describe the main routes and mechanisms of xenobiotic elimination

● Interpret the xenobiotic interactions at excretion mechanisms

● Predict xenobiotic mechanism of excretion, considering its physical-

chemical characteristics

Audience (possible targets) Students (University, PhD or Master) of degrees: ● Pharmacy

● Medicine

● Nursing

● Veterinary medicine

● Biology

● Environmental Engineering

● Forensic sciences

Students of Vocational training

● Pharmacy assistant

● Nursing assistant

● Veterinary assistant

● Laboratory technicians

Professionals in fields related to toxicology

● Pharmacists

● Occupational medicine professionals

● Forensics

● Supervisory bodies

● Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Portuguese version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Topic 2.4: Xenobiotic Metabolism (2 ECTS)

Name of the Topic 2.4: Xenobiotic Metabolism

Date of release / last update 18 may 2016

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Félix Carvalho (UPorto)

Short descriptions This module aim to describe the phenomena of pharmaco-toxicokinetic and contextualize the pharmacological and toxicological consequences related to the metabolism of xenobiotics (drugs and toxic compounds), namely their bioactivation and detoxification. The students will contact with movies showing the metabolic processes as well as research data that will allow them to interpret the risks associated with xenobiotic exposure related to their disposition in the organism.

Intended learning outcomes The main Learning Objectives of this module are: ● To know the main metabolic processes, highlighting the classic mechanisms

of bioactivation

Learning Outcomes: at the end of this module, the learner should be able to:

● Concerning the xenobiotic metabolism:

● Identify the main metabolic organs;

● Describe the different metabolic phases (Phase 1 and 2)

● Interpret the way by which Phase 0 and 3 modulate the metabolic processes

● Explain the phase I metabolism, namely the microsomal and the non-

microssomal enzymatic reactions, as well as types of reactions (oxidation,

reduction, hydrolysis) and the main enzymes catalyzing these reaction;

● Illustrate the importance of Cytochrome P450 in xenobiotic metabolism,

highlighting the principal isoenzymes involved;

● Explain the phase II metabolism;

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● Recognize the main bioactivation processes, namely reactions (e.g.

oxidation, reduction, glucuronidation); enzymes involved (e.g. Cytochrome

P450, Peroxidases and Glucuronosyl transferases); chemical structures

(e.g. epoxides, quinones, aromatic amines);

● Discriminate the destoxification/bioactivation pathways in metabolic profile of

classic xenobiotics in Toxicology.

Audience (possible targets) Students (University, PhD or Master) of degrees: ● Pharmacy

● Medicine

● Nursing

● Veterinary medicine

● Biology

● Environmental Engineering

● Forensic sciences

Students of Vocational training

● Pharmacy assistant

● Nursing assistant

● Veterinary assistant

● Laboratory technicians

Professionals in fields related to toxicology

● Pharmacists

● Occupational medicine professionals

● Forensics

● Supervisory bodies

● Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Portuguese version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Module 3: Principal Groups of Xenobiotics (4 ECTS)

Topic 3.1: Prescription Drugs (2 ECTS)

Name of the Topic 3.1: Prescription Drugs

Date of release / last update 14 June 2016

Author/s Luca Ferrari (UniBo) Stefano Girotti (UniBo) Luigi Guerra (UniBo) Roberto Mandrioli (UniBo) Laura Mercolini (UniBo) Michele Protti (UniBo)

Short description This topic describes the main toxicological characteristics of prescription drugs and

their legal status. Analytical methods for their qualitative and quantitative

determination in different biological and non-biological matrices will be described and

discussed. The most important aspects of regulations in the pharmaceutical sector

will be provided and explained.

Intended learning outcomes At the end of this module, the learner should be able to:

- describe the main sources and contents of regulations in the pharmaceutical

sector;

- identify, understand and follow GLP and GMP;

- know and identify the most important toxicological effects of drugs;

- find, understand, evaluate and use scientific and official publications to analyze

different kinds of pharmaceutical and toxic substances;

- apply the information received to a forensic setting.

For each class of prescription drugs, the student should be able to:

- cite and identify the main members of the class;

- hypothesize one or more possible analytical strategies that could be suitable for

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most drugs in the class;

- search the literature and find relevant papers and guidelines for the sampling,

sample pre-treatment and analysis of the drugs belonging to the class;

- participate in, and contribute to, decisional processes and practical work related to

forensic and other highly regulated analytical fields;

- actively participate in certification and accreditation procedures.

Audience (possible targets) - Bachelor, Master and Ph.D. students in the health and life sciences field (e.g.

chemistry, biotech, pharmacy, hygiene, medicine, etc.)

- People working in scientific R&D

­- People interested in this field (a technical knowledge in chemistry and/or biology

would be preferable).

Available languages English, Italian and the languages of all involved countries ( Spanish, Portuguese,

Czech, Romanian, Bulgarian, Finnish)

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Topic 3.2: Drugs of Abuse (2 ECTS)

Name of the Topic 3.2: Drugs of Abuse

Date of release / last update 14 July 2016

Author/s Luca Ferrari (UniBo) Stefano Girotti (UniBo) Luigi Guerra (UniBo) Roberto Mandrioli (UniBo) Laura Mercolini (UniBo) Michele Protti (UniBo)

Short description This topic describes the main chemical, pharmacological and toxicological

characteristics of abuse drugs and their legal status. Analytical methods for their

identification and quantitation in different complex matrices will be described and

discussed.

Intended learning outcomes At the end of this module, the learner should be able to:

- name the main drugs of abuse;

- know their chemical and toxicological properties;

- find, understand, evaluate and use scientific and official publications to identify and

quantify different kinds drugs of abuse;

- elaborate an autonomous, original strategy to solve the most frequent/important

problems encountered in the sampling, pre-treatment and analysis of complex

matrices to determine the presence and amount of drugs of abuse;

- apply the information received to a forensic setting.

For each class of abuse drugs, the student should be able to:

- cite and identify the main members of the class;

- hypothesize one or more possible analytical strategies that could be suitable for

most drugs in the class;

- search the literature and find relevant papers and guidelines for the sampling,

sample pre-treatment and analysis of the drugs belonging to the class;

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- participate in, and contribute to, decisional processes and practical work related to

forensic and other highly regulated analytical fields.

Audience (possible targets) - Bachelor, Master and Ph.D. students in the health and life sciences field (e.g.

chemistry, biotech, pharmacy, hygiene, medicine, etc.)

- People working in scientific R&D

­- People interested in this field (a technical knowledge in chemistry and/or biology

would be preferable).

Available languages English, Italian

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Module 4: Environmental Pollutants (7 ECTS)

Topic 4.1: Gaseous Pollutants (1 ECTS)

Name of the Topic 4.1: Gaseous Pollutants

Date of release / last update 14.07.2016

Author/s Ileana Manciulea (UTBv) Dana Perniu (UTBv)

Last release 14.07.2016

Short descriptions This module describes general information about air pollution, main gaseous inorganic and organic pollutants (classification and description), sources of air pollutants and possibilities of air pollution reduction. The main learning objectives of this module are: - to understand the concept of air pollution; - to identify gaseous pollutants and their sources; - to introduce the basic toxicology terminology associated to gaseous pollutants; - to describe the impact of gaseous pollutants on the human health, as well as on the environment; - to analyse a case study. Bibliography Glossary

Intended learning outcomes After learning of this module, students will be able to: - describe the main air pollutants;

- identify the pollution sources and their effect on environment;

- understand the human health concerns associated with the distribution of

gaseous pollutants in indoor and atmospheric air;

- select air pollutants in a case study and to analyze the main pollutant.

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Audience (possible targets) ● Bachelor, Master and Doctor students of energy and environmental

engineering

● Authorities in environmental sector

● Environmentally aware citizens

Available languages First in English by authors, then by partners in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish.

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Topic 4.2: Heavy Metals (1 ECTS)

Name of the Topic 4.2: Heavy Metals

Date of release / last update 10.07.2016

Author/s Marie Voprsalova (CUNI)

Short descriptions The aim of this topic is to describe the impact of heavy metals on the human health, as well as on the environment

Intended learning outcomes Students will be able: ● to identify sources of toxic agents

● to explain the mechanism of action

● to interpret the fate of toxic agents in the organism

● to recomend the biological material for the laboratory determination

● to distinguish acute and chronic intoxications

● to compare the use of antidotes,chelating agents during intoxications

● to predict and estimate risks on the human health

Audience (possible targets) Students in the health professions, physicians, hygienists

Available languages English and other languages (Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish)

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Topic 4.3: Persistent Organic Pollutants (1 ECTS)

Name of the OER

4.3: Persistent Organic Pollutants

Date of release / last update 14.07.2016

Author/s Ileana Manciulea (UTBv) Lucia Dumitrescu (UTBv)

Short descriptions The aim of this module is to describe the persistent organic pollutants (POPs), such as polyaromatic hydrocarbons (PAH), biodegradation obsolete pesticides, polychlorinated biphenyl (PCB), dioxins and polychlorinated furane. The main learning objectives of this module are: - to identify POPs and their sources; - to understand POPs persistence in environment; - to describe the impact of POPs on the human health, as well as on the environment - to analyse a case study. Bibliography Glossary

Intended learning outcomes After learning of this module, students will be able to: - describe the main classes of chemicals included in POPs;

- identify POPs sources and their effect on environment;

- understand the environmental and human health concerns associated with the

distribution of POPs in environment, the human health effects associated with

acute and chronic exposure to POPs;

- explain POPs bioaccumulation in water, soil and living organisms;

- select air pollutants in a case study and to analyze the main pollutant.

Audience (possible targets) ● Bachelor, Master and Doctor students of energy and environmental

technology

● Authorities in environmental sector

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● Environmentally aware citizens

● General audience interested in toxicology

Available languages First in English by authors, then by partners in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish.

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Topic 4.4: Pesticides I (2 ECTS)

Name of the Topic 4.4: Pesticides I

Date of release / last update Release: 22.04.2016; Last update: 13.06.2016

Author/s Lubomir Simeonov (SRTI-BAS) Yordan Simeonov (SRTI-BAS)

Short descriptions The topic is introductory for the broad area of pesticide study and deals with issues as the: basic definitions, historical overview of pesticide invention and application, significance of the pesticides and application areas, as well as definition of hazardous pesticides and related environmental pollution and ecotoxicology. A significant issue of the topic are the human health concerns associated with the distribution of hazardous pesticides in the environmental media.

Intended learning outcomes The principle learning objectives of this topic are: - to introduce the basic toxicology terminology used in connection to associated

with pesticide distribution in the environment and the adverse effects on human health and related diseases. After learning this topic students will get knowledge and will be able to:

- characterize the environmental and human health impacts of pesticide pollution and discuss the health effects associated with acute and chronic exposure to pesticides and adverse effects and diseases as allergies, hypersensitivity, developmental and cancerogenic effects, damage to the central and peripheral nervous system, reproductive disorders, disruption of the hormonal and the endocrine systems, etc. Bibliography Glossary

Audience (possible targets) Students (University, PhD) degrees in:

Pharmacy, Medicine, Nursing, Veterinary medicine, Biology

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Environmental Sciences & Engineering, Forensic sciences, Professionals in fields

related to toxicology, Occupational medicine professionals

General audience interested in toxicology

Available languages First in English by authors, then by partners in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish.

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Topic 4.5: Pesticides II (2 ECTS)

Name of the Topic 4.5: Pesticides II

Date of release / last update Release: 22.04.2016; Last update: 13.06.2016

Author/s Lubomir Simeonov (SRTI-BAS) Yordan Simeonov (SRTI-BAS)

Short descriptions The goal of the topic is to deliver knowledge on the issues of: Pesticide Legislation and Registration, Inventories, Integrated Pest Control (IPC) and Integrated Pest Management (IPM) as well as the issue of Biological Pesticides. A special issue will be the Environmental Security.

Intended learning outcomes The principle learning objectives of this topic are in concern to: Pesticide legislation and registration - general approaches and procedures, Inventories, the Integrated Pest Control (IPC) and the Integrated Pest Management (IPM) as well as the emerging biological pesticides and the objectives of the Environmental Security. After learning this topic students will get knowledge on: Inventories: pesticide production, import, export, lists of producers, companies, suppliers, trade and distribution, packing and labeling, transport, storage and disposal, application; Personnel training requirements, licensing; Identification of responsible authorities for Pesticide Regulation; International Organisations - WHO, FAO, UNEP, USEPA, IARC, etc. Specialized websites on Pesticides. Specialized Programs (PESTIDOC, PAN Pesticide, SAFEFOODNET, etc.). Environmental Security: Military applications of POPs/Pesticides, transboundary pollution, organic arsenicals, Dioxin; Agent Orange and Agent Blue Bibliography. Glossary.

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Audience (possible targets) Students (University, PhD or Master) of:

Pharmacy, Medicine, Nursing, Veterinary medicine, Biology

Environmental Sciences & Engineering, Forensic sciences, Professionals in fields

related to toxicology, Occupational medicine professionals

General audience interested in toxicology

Available languages First in English by authors, then in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish by partners.

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Module 5: Target Organ Toxicity and Biomarkers (8 ECTS)

Topic 5.1: Cardiovascular Toxicology (2 ECTS)

Name of the Topic 5.1: Cardiovascular Toxicology

Date of release / last update 22/04/2016

Author/s Přemysl Mladěnka (CUNI)

Short descriptions The main aim of this topic is to give the reader an overview of mechanisms of cardiovascular toxicity in relation to both clinically used drugs, misused drugs (e.g. amphetamines, cocaine, cigarette smoking) and toxins. Particular emphasis is given to the heart since toxic effect on the heart might result in irreversible damage or even death and could be associated with a row of drugs (like QT interval prolongation followed by potentially fatal dysrhythmias). The chapter explains also physiology of action potential conduction in the heart in order to enable to readers not-familiar with cardiovascular problematics to have a base for understanding of toxic effects of drugs. At the end, also chapters related to vascular toxicology and biomarkers of cardiotoxicity are placed.

Intended learning outcomes The main Learning Objectives of this topic are: ● to introduce the cardiovascular physiology (e.g. action potential conduction

in the heart, contractility-action potential coupling, impact of sympathetic and

parasympathetic nervous system)

● to describe the forms of cardiovascular toxicology (dysrhythmias,

derangement in coronary perfusion, direct toxic effects on myocardium)

● to define the types of drugs associated with cardiotoxcity and to mention the

main treatment modalities of intoxications

● to discuss biomarkers of cardiotoxicity

After learning of this module, students will be able to:

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● know the reasons why drugs can be cardiotoxic

● identify the main types of concrete drugs associated with cardiotoxicity and

treatment modalities of such intoxications

● determine the information provided by each biomarker of cardiovascular

damage.

Audience (possible targets) Students (University, PhD or Master) of degrees: -Pharmacy -Medicine -Nursing -Veterinary medicine -Biology -Environmental Engineering -Forensic sciences Students of Vocational training: -Pharmacy assistant -Nursing assistant -Veterinary assistant -Laboratory technicians Professionals in fields related to toxicology: -Pharmacists -Occupational medicine professionals -Forensics -Supervisory bodies -Police forces General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an English version will be created. Translations into the languages of all involved countries will be the final outcome.

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Topic 5.2: Pulmonar Toxicity (1 ECTS)

Name of the Topic 5.2: Pulmonary Toxicity

Date of release / last update 22.4.2016

Author/s Jana Pourova (CUNI)

Short descriptions The aim of this topic is to understand how the exposure to toxicants (noxious air-borne agents and blood-borne agents) can affect the respiratory system.

Intended learning outcomes The main Learning Objectives: - Facts about respiratory system (both anatomy and physiology) relevant to

toxicology will be explained.

- The main factors affecting the pulmonary toxicity (such as physical state of

noxious agents, size of particles or pattern of breathing) will be discussed.

- The main pathological entities (such a fibrosis, an emphysema, a pulmonary

edema or an acute respiratory distress syndrome) will be explained.

- The most important examples of toxic agents known to produce a lung injury

in humans will be described.

After learning of this module, students will:

- know the main mechanisms and factors involved in pulmonary toxicology.

- know the most common types of toxic respiratory injury and the main

pathological entities.

- know the most important toxic agents producing respiratory injury in

humans.

Audience (possible targets) Students (University, PhD or Master) of degrees:

-Pharmacy

-Medicine

-Nursing

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-Veterinary medicine

-Biology

-Environmental Engineering

-Forensic sciences

Students of Vocational training

-Pharmacy assistant

-Nursing assistant

-Veterinary assistant

-Laboratory technicians

Professionals in fields related to toxicology

-Pharmacists

-Occupational medicine professionals

-Forensics

-Supervisory bodies

-Police forces

General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish

First, an English version will be created. Translations into the languages of all involved countries will be the final outcome.

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Topic 5.3: Renal Toxicity (2 ECTS)

Name of the Topic 5.3: Renal Toxicity

Date of release / last update 22/04/2016

Author/s Ana Isabel Morales Martín (USAL) Marta Prieto Vicente (USAL) Moisés Pescador Garriel (USAL) Laura Vicente Vicente (USAL) Alfredo Ginés Casnova Paso (USAL) Mª Teresa Hernández Sánchez (USAL)

Short descriptions The goal of this topic is to understand how the exposure to toxicants (drugs, drugs of abuse environmental toxicants) can affect the kidney. Another point to learn are the mechanisms involved in this damage in each specific place of renal anatomy (Glomerular injury, proximal-tubular injury, loop of Henle/distal tubule/collecting duct injury, papillary injury). The nephrotoxicity biomarkers used in the detection or measurement of the damage induced by the toxicant also will be explain.

Intended learning outcomes The main Learning Objectives of this topic are: - To introduce the renal pathophysiology - To describe the clinical forms of nephrotoxicity - To define the types of toxic renal injury produced by drugs and metals - To know the nephrotoxicity biomarkers

After learning of this module, students will be able to:

- Know the kidney susceptibility to toxicants and the pathophysiological response to it - Identify the main types of toxic renal injury and indicate concrete examples. - Determine the information provided by each biomarker of kidney damage.

Audience (possible targets) Students (University, PhD or Master) of degrees: -Pharmacy

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-Medicine -Nursing -Veterinary medicine -Biology -Environmental Engineering -Forensic sciences Students of Vocational training: -Pharmacy assistant -Nursing assistant -Veterinary assistant -Laboratory technicians Professionals in fields related to toxicology: -Pharmacists -Occupational medicine professionals -Forensics -Supervisory bodies -Police forces General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Spanish version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Topic 5.4: Liver Toxicity (2 ECTS)

Name of the Topic 5.4: Liver Toxicity

Date of release / last update 18 may 2016

Author/s Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Renata Silva (UPorto) Diana Silva (UPorto) Margarida Araújo (UPorto) Maria João Valente (UPorto)

Short descriptions The goal of this topic is to understand how the exposure to toxicants (drugs, drugs of abuse and environmental toxicants) can affect the liver. Another point to learn are the mechanisms involved in this damage in each specific place of liver anatomy (periportal, midzonal, centrolobular and biliary cells). The hepatotoxic biomarkers used in the detection or measurement of the damage induced by the toxicant also will be explain.

Intended learning outcomes At the end of this topic, the learner should be able to: ● Describe the main characteristics of vulnerability to toxicity of liver

● Differentiate the main damage types induced by hepatotoxic compounds

● Explain the main mechanisms by which xenobiotics can induce hepatotoxic

effects

● Recognize the main hepatotoxic drugs and other xenobiotics

● Interpret the main bioactivation processes as hepatotoxic effects

● identify and interpret the main biomarkers of hepatotoxicity

Audience (possible targets) Students (University, PhD or Master) of degrees: -Pharmacy

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-Medicine -Nursing -Veterinary medicine -Biology -Environmental Engineering -Forensic sciences Students of Vocational training -Pharmacy assistant -Nursing assistant -Veterinary assistant -Laboratory technicians Professionals in fields related to toxicology -Pharmacists -Occupational medicine professionals -Forensics -Supervisory bodies -Police forces General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Portuguese version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Topic 5.5: Nervous System Toxicity (1 ECTS)

Name of the Topic 5.5: Nervous System Toxicity

Date of release / last update 22/04/2016

Author/s

Ana Isabel Morales Martín (USAL) Marta Prieto Vicente (USAL) Moisés Pescador Garriel (USAL) Laura Vicente Vicente (USAL) Alfredo Ginés Casnova Paso (USAL) Mª Teresa Hernández Sánchez (USAL)

Short descriptions The goal of this topic is to understand how the exposure to toxicants can affect the nervous system, especially in the synapse, and to learn the main clinical forms of neurotoxicity (Neuronopathies, Axonopathies, Myelinopathies, Neurotransmission-associated neurotoxicity). Another objective of this topic is to identify the toxicants involved in the neurodegenerative processes.

Intended learning outcomes The main Learning Objectives of this topic are: - To introduce the nervous system pathophysiology - To describe the clinical forms of neurotoxicity - To define the neurodegenerative processes of toxic origin

After learning of this module, students will be able to: - Know the major targets affected by neurotoxic agents: neuron, axon, the myelinating cell system neurotransmitters - Identify the main neurological manifestations (neuronopathies, axonopathies, myopathy, myopathy, vascular disease) and associate them to concrete examples of neurotoxic agents.

Audience (possible targets) Students (University, PhD or Master) of degrees: -Pharmacy -Medicine -Nursing

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-Veterinary medicine -Biology -Environmental Engineering -Forensic sciences Students of Vocational training -Pharmacy assistant -Nursing assistant -Veterinary assistant -Laboratory technicians Professionals in fields related to toxicology -Pharmacists -Occupational medicine professionals -Forensics -Supervisory bodies -Police forces General audience interested in toxicology

Available languages English, Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian, Finnish First, an Spanish version will be created. Translations into the languages of all involved countries and English will be the final outcome.

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Module 6: Environmental Toxicology (7 ECTS)

Topic 6.1: European and National Regulations related to Environmental Quality (2 ECTS)

Name of the Topic 6.1: European and National Regulations Related to Environmental Quality

Date of release / last update 12.5.2016 / 17.02.2017

Author/s Camelia Draghici (UTBv) Cristina Rotaru Salca (UTBv) Ana Isabel Morales Martín (USAL) Marta Prieto Vicente (USAL) Laura Vicente Vicente (USAL) Moisés Pescador Garriel (USAL) Alfredo Ginés Casanova Paso (USAL) Mª Teresa Hernández Sánchez (USAL) Fernando Remião (UPorto) Maria de Lourdes Bastos (UPorto) Helena Carmo (UPorto) Renata Silva (UPorto) Diana Silva (UPorto) Margarida Araújo (UPorto) Maria João Valente (UPorto) Luca Ferrari (UniBo) Stefano Girotti (UniBo) Luigi Guerra (UniBo) Roberto Mandrioli (UniBo) Laura Mercolini (UniBo) Michele Protti (UniBo) Premysl Mladenka (CUNI) Jana Pourova (CUNI) Marie Voprsalova (CUNI) Lubomir Simeonov (SRTI-BAS)

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Yordan Simeonov (SRTI-BAS) Merja Mäkelä (XAMK)

Short descriptions This topic summarizes the regulations of authorities. Following national guidelines will be given:

● accepted limits of toxic pollutants in air, water and soil (emissions and

imissions)

● integrated pollution prevention and control

● environmental monitoring

● environmental impact assessment

Learning objective: After learning this topic, students will be able to ● to evaluate personal and authoritative rights and duties with toxic pollutants.

Intended learning outcomes After learning of this module, students will be able to ● compare the level of toxic pollutants evacuated in the environment, with the

related concentration limits, according to specific national regulations.

Audience (possible targets) ● Bachelor, Master and Doctor students of energy and environmental technology

● Power plants, industry, agricultural and other operators, project and maintenance

engineers

● Authorities in energy and environmental sector

● Environmentally aware citizens

Available languages First in English by authors, then in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish by partners.

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Topic 6.2: Control of Emissions from Anthropogenic Activities and Safety (2 ECTS)

Name of the Topic 6.2: Control of Emissions from Anthropogenic Activities and Safety

Date of release / last update 12.6.2016 / 17.3.2017

Author/s Merja Mäkelä (XAMK)

Short descriptions This topic concentrates on the methods how to affect the toxic compounds (gases, liquids and particulate matter) coming from

● extractive activities and natural resources processing (solid minerals, oil,

natural gases)

● power production based on the combustion of fossil fuels (coal, oil, natural

gas) and renewable fuels (biomass, municipal waste), and on the use of

radioactive materials

● industrial activities

● agricultural activities

● transport (roads, railways, maritime, air traffic)

● wastewater treatment

● different deposits (waste, ash, sludge)

In addition, safety related issues are discussed.

Intended learning outcomes Learning objectives: The main learning topic are:

● toxic emissions coming from power production

● measurement, monitoring and control of emissions in power production

● safety with emissions

Learning outcomes: After learning this topic, students will be able to

● explain how to measure and monitor emissions in power production

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● describe and analyze basic methods how to affect the production processes

generating toxic emissions, using, process flow charts and diagrams

● assess safety conditions and apply related safety guidelines when dealing

with toxic substances.

Audience (possible targets) ● Bachelor, Master and Doctor students of energy and environmental

technology

● Power plant, industry, agricultural and other operators, project and

maintenance engineers

● Authorities in energy and environmental sector

● Environmentally aware citizens

Available languages First in English by authors, then in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish by partners.

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Topic 6.3: Introduction to the Environmental Quality Monitoring System

Name of the Topic

6.3: Introduction to the Environmental Quality Monitoring System

Date of release / last update 12.6.2017

Author/s Camelia Draghici (UTBv)

Short descriptions This topic discusses the monitoring systems ● general environmental monitoring scheme and related activities ● principles of sampling and sample pre-treatment ● analytical methods applicable for pollutants measurements in environment;

quality requirements for analytical measurements ● data collection, processing and reporting.

Learning objectives: After learning this topic, students will be able to:

● to understand the structure of monitoring systems (flow scheme and related activities)

● to understand the necessary activities to undergo for the pollutants measurements from environmental samples (air, waters and soils)

Bibliography Glossary

Intended learning outcomes Learning outcomes: After learning of this topic, students will be able to:

● identify and describe the standard methods available for pollutants measurements

● organize and analyze the information from environmental monitoring, using tables, figures/diagrams, messages or online displays

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Audience (possible targets) ● Bachelor, Master and Doctor students of energy and environmental

technology

● Power plants, industry, agricultural and other operators, project and

maintenance engineers

● Authorities in energy and environmental sector

● Environmentally awared citizens

Available languages First in English by authors, then in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish by partners.

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Topic 6.4: Monitoring the Environmental Quality - Air, Water, Soil (2 ECTS)

Name of the Topic

6.4: Monitoring the Environmental Quality - Air, Water, Soil

Date of release / last update 17.2.2017

Author/s Camelia Draghici (UTBv)

Short descriptions This topic discusses the monitoring systems for air, water and soil quality

● European and national monitoring systems (information needed from all

partners)

● sampling and sample pretreatment

● standard analytical methods available for xenobiotic measurements in

environment

● data collection, processing and reporting Learning objectives: After learning this topic, students will be able to

● to understand the structure of monitoring systems and information flow in

them

● to evaluate the environmental impact of toxic compounds emissions and

imissions in the environment.

Bibliography Glossary

Intended learning outcomes Learning outcomes: After learning of this topic, students will be able to

● describe and analyze the information of monitoring systems using online

displays, tables and messages

● compare the level of toxic pollutants evacuated in the environment, with the

related concentration limits, according to specific regulations

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● make basic operation recommendations based on the information of

monitoring systems.

Audience (possible targets) ● Bachelor, Master and Doctor students of energy and environmental

technology

● Power plants, industry, agricultural and other operators, project and

maintenance engineers

● Authorities in energy and environmental sector

● Environmentally aware citizens

Available languages First in English by authors, then in Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and Finnish by partners.

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Module 7: Patents and Patent Application (2 ECTS)

Topic 7.1 - European legislation, Patentability, Structure of patents, Forensic applications of

patents (2 ECTS)

Name of the Topic 7.1 - European legislation, Patentability, Structure of

patents, Forensic applications of patents

Date of release / last update 10.05.2016

Author/s Simone Mangini (Unibo)

Short description Examples of patents are provided.

The requirements for patentability will be presented including novelty and inventive

step. Also formal requirements (such as sufficiency of disclosure) will also be

discussed.

The priority right, its relevance and the conditions to take advantage of such a tool

will be discussed.

Typical issues relating to patents and patentability in the fields of chemistry,

pharmacy and biotechnology will be presented. For example, protection for new

uses of known substances, general formulas, exclusion of patentability on the basis

of being contrary to the morality. The patentability of polymorphisms will be

considered with particular accuracy.

The procedure for filing and prosecuting European patent applications will be

presented.

The procedure for filing and prosecuting International patent applications will be

presented.

Economic and statistical data relating to patents and IP in general will presented.

How litigation is carried out in the patent field will be presented. Also examples will

be discussed. Particular systems will be analyzed more in depth.

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Intended learning outcomes The students should be able to:

- understand that patents are varied. Some of them may relate to funny things, many

contain important technical and scientific information. Patent databases may be

used may be use for scientific/technical and industrial purposes

- identify the main issues about patentability and when something is plainly not

patentable

- understand the advantages provided by the priority right. Procedural and strategic

use of the priority right should be understood

- understand that particular issues apply in the field of life sciences

- understand how the examination of applications is carried out and which are the

advantages and disadvantages of the European patent system

- understand how the PCT works

- understand the importance of the pantent system and how patents can be an

indication of technical ed economical development

- understand the complexity of patent litigation

Audience (possible targets) ­ Bachelor, Master and PhD students in the life scince field (e.g. chemistry, biotech,

pharmacy etc.)

­ Managers of private and public companies that deal with innovation

- People working in R&D

­ People interested in filed (a technical knowledge in life science would be

preferable).

Available languages Italian, English readings

Italian audio + English subtitles

Then Italian audio +Spanish, Portuguese, Italian, Czech, Romanian, Bulgarian and

Finnish subtitles

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List of authors

University of Salamanca (USAL) Ana Isabel Morales Martín Marta Prieto Vicente Laura Vicente Vicente Moisés Pescador Garriel Alfredo Ginés Casanova Paso Mª Teresa Hernández Sánchez

University of Bologna (UniBo) Luca Ferrari Stefano Girotti Luigi Guerra Roberto Mandrioli Laura Mercolini Michele Protti

Simone Mangini

University of Porto (UPorto) Fernando Remião Maria de Lourdes Bastos Helena Carmo Renata Silva Diana Silva Margarida Araújo Maria João Valente

Félix Carvalho

Charles University (CUNI) Premysl Mladenka Jana Pourova Marie Voprsalova

University Transilvania of Brasov (UTBv) Camelia Draghici Dana Perniu Ileana Manciulea Lucia Dumitrescu Cristina Rotaru Salca

South-Eastern Finland University of Applied Sciences (XAMK) Merja Mäkelä (XAMK) Mirva Pilli-Sihvola (XAMK) Kim-Laura Kern (XAMK)

Space Research and Technology Institute - Bulgarian Academy of Sciences (SRTI-BAS) Lubomir Simeonov

Yordan Simeonov

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