INFORMATION, PRE-REGISTRATION AND REGISTRATION
Telephone: 91 488 70 40
Academic direction: Yolanda Valcarcel Rivera
The fundamental objective of this course is to familiarize the student with the conceptual framework of the risk assessment process (RE) for both health and the environment, derived from exposure to a chemical compound or mixture of compounds.
This procedure is framed in a harmonized process regulated by the European Union, through European Agencies. The member countries of the European Union, such as Spain, participate in this risk assessment process by designating competent Authorities, which have teams of experts in this discipline.
With the departure of the United Kingdom from the European Union, the workload for the rest of the countries has increased, generating the need for experts to cover this demand for work. In addition, the work of risk assessment is not only necessary in the competent Authorities of each country or European Agencies -regulatory level-, but it is also generated in the cabinets of the Industry that prepare the informative dossiers. Consequently, there is a high demand for experts in the discipline of risk assessment. This demand is not covered in the different grades, so it is necessary to cover it with specialized courses. This course, therefore, creates an opportunity and professional opportunity for students and graduates, already verified by the demand it has had when it has been taught as training within the environmental toxicology degree itself. Currently there is a great demand from companies in the chemical sector, in which we train students and workers in this field.
In Module 2, they will acquire the knowledge acquired to carry out a health risk assessment, a methodology totally different from the evaluation of environmental risks. Students will learn the regulations required by the authorities to allow the marketing and use of certain chemical substances. To do this, students will learn the concepts and methodology of the health risk assessment process of a chemical substance already on the market, and which is available to anyone, both for personal use and to improve quality of life (handling of pests, antiseptics, cosmetics...) as well as learn the applicable regulations in the procedure. Students will become familiar with hazard identification procedures through toxicological tests with experimental animals and alternative methods to animal experimentation. Subsequently, students will acquire expertise in the use of deterministic models for the evaluation of exposure.
Students will be introduced to the concept of biomonitoring of chemical contaminants in humans, both in the general population and in the workplace. The classes will be theoretical-practical, where students will put into practice the knowledge acquired to carry out a health risk assessment derived from the use and/or application of chemical substances, with cases applied to the theoretical part.
All this encompassed in the European regulation REACH: Registration, Evaluation, Authorization and Restriction of chemical substances.
Module 2. This subject aims, as a general objective, to introduce students to the discipline of health risk assessment of chemical substances already on the market and widely used by the population: deodorants, biocides, cosmetics, phytosanitary products…. More specifically, the objectives are:
1.-Learn the concepts and methodology of the chemical substance risk assessment process, within the current REACH regulations; authorization and management of this type of substance.
2.-To become familiar with the procedures for hazard identification through toxicological tests with experimental animals and alternative methods to animal experimentation.
3.-Acquire expertise in the use of deterministic models for the evaluation of exposure
4.-Know the biosurveillance tools, both in the occupational population and in the sectors of the general population that could be affected.
5.-Put into practice the knowledge acquired to carry out a health risk assessment derived from the use and/or application of chemical substances.
- Students would acquire the knowledge and practical skills necessary to carry out a health risk assessment of chemical substances, already marketed, or that are to be marketed, applying the current European REACH regulation, which is what companies are going to request from them.
- Learn the applicable regulations in the risk assessment procedure (application of the REACH regulation, application and interpretation of the CLP, and the chemical safety data sheets).
- Knowledge of the main animal experimentation trials that are carried out, and interpret the data published on them, such as lethal dose, toxic dose, NOAEL...
- Apply the health risk assessment methodology to determine if a substance already marketed or to be marketed is harmless to human health.
- Know what biomonitoring is and learn about the main biomonitoring studies (seroprevalence) of chemical substances that have been and are being carried out.
MODULE 2. HEALTH RISK ASSESSMENT.
Topic 1. Specific toxicological concepts in the field of knowledge of health risk assessment.
Topic 2. Legislation applied to the health risk assessment process: Applicable Regulations and Directives.
Topic 3. Management of specific toxicological databases and applicable acceptance criteria in the health risk assessment process.
Topic 4. Description of toxicological tests in mammals, relevant information contained and implementation in the health risk assessment process.
- 4.1 Toxicokinetics and metabolism.
- 4.2 Acute toxicity (oral, inhalation, dermal).
- 4.3 Subchronic toxicity.
- 4.4 Chronic toxicity and carcinogenesis.
- 4.5 Reproductive and developmental toxicity.
- 4.6 Neurotoxicity.
- 4.7 Other complementary studies.
Topic 5. Human studies.
- 5.1. Main measures of “risk” in humans
- 5.2. Epidemiological studies. Objectives and purposes
- 5.3. descriptive studies. Concept of “biosurveillance” studies.
- 5.4. analytical studies
- 5.5. clinical trials
Topic 6. What is biomonitoring?
- 6.1. Biomonitoring programs in Europe.
- 6.2. Qualities and selection of populations in HBM studies.
- 6.3. Types, characteristics and qualities of the biological matrices used in human biomonitoring studies.
- 6.4. Biomarker selection criteria in HBM studies.
- 6.5. Aspects related to the analytical determination of the main compounds addressed in HBM studies in the general population.
- 6.6. Data analysis, interpretation and communication of results of HBM studies.
- 6.7. Quality assurance programs in HBM studies.
Practical case (Not evaluable, yes advisable)
- Higher university graduates with a level equivalent to a Bachelor's or Bachelor's degree in a discipline such as Environmental Sciences, Environmental Engineering, Chemistry, Biochemistry, Forestry Engineering, Geologists, Veterinary Medicine, Biology, or another discipline with comparable training.
- Knowledge of English in both reading comprehension and writing, equivalent to a First level (B2)
Exceptionally, students who are missing up to 30 credits to finish their Degree and/or who are only missing the TFG may be accepted. In this regard, the director of the course will decide whether or not to accept these students, based on their academic record (above 7.00). Besides, The final title of the course will be delivered when they have obtained the degree.
Each module can be done independently. The title of SUPERIOR UNIVERSITY COURSE OF RISK ASSESSMENT OF CHEMICAL SUBSTANCES FOR THE ENVIRONMENT AND HEALTH will be obtained once the modules that the title consists of have been passed.
To carry out the course, the virtual platform (Moodle) of the Rey Juan Carlos University will be available. Students will have the platform forum to communicate their doubts to the teachers who teach the course, or any question that arises during the delivery of the course.
They will also be able to communicate via email with the teachers who participate in it.
Academic Management and Faculty
Academic secretary: Mr. Jesús García-Cambero. Spanish Medicines Agency.
Teresa Gomez Martin. Spanish Medicines Agency.
Celia Cerrato Rivera. I'm waiting on Health Risk Assessment.
Dr. Marta Esteban López. Carlos III Health Institute.
Nadia Martin Blanco. Expert in Health Risk Assessment.
Juan Jose Ramos. Carlos III Health Institute
Miguel Angel Lucena. Carlos III Health Institute.
Duration and development
Modality: Remote (URJC's Moodle platform, and prior agreement with the students, a session may be held with the Teams platform or similar)
Total ECTS: 3
Remote hours: 30h (each module)
Platform or virtual environment (URJC or others): MOODLE
Start: June 15, 2021 End: June 28, 2021 (Module 2)
Reservation of place and enrollment
Pre-registration period from March 15 to May 24, 2021
Registration period from June 1 to 4, 2021
Start and end date: from 15 to 28 June 2021
Title price: €280
In the event that the number of applications exceeds the number of places offered, a selection will be made based on the following criteria:
- KNOWLEDGE OF ENGLISH (priority will be given to the admission of the student with the highest level, and who can prove it).
- ACADEMIC RECORD
The start of the course depends on the number of students enrolled.
Documentation to attach, forms and place of delivery
the applicants they will present all the scanned documentation, in the formats allowed through the telematic self-registration application at the time of applying for admission to own degrees. They must compulsorily attach to their request the declaration of the person responsible for the veracity of the data provided in digital format.
At any time, both the Program Management and the Own Teaching Service may request the applicants to submit said certified/collated documentation through the General Registry, located on the Móstoles Campus, or in any of the registries assistants located in the different campuses of the Rey Juan Carlos University, or by sending it through Certified Mail to: Rey Juan Carlos University. General Registry. Avda. Tulipán s/n. 28933. Mostoles. Madrid
The student is responsible for the veracity and correctness of the data provided, exonerating the Rey Juan Carlos University from any responsibility and guaranteeing and being responsible for its accuracy, validity and authenticity.
Students with a degree obtained from a Spanish university or a Higher Education Institution belonging to another Member State of the European Higher Education Area that authorizes access to own postgraduate degrees must present the following documentation:
- National Identity Document or equivalent
- University degree of the studies that give access to the requested postgraduate degree.
- Curriculum vitae
- Responsible declaration of veracity of the data provided in digital format
- Any other document that the Director of the Own Title specifically requires for its acceptance
Students with a foreign degree must present the following documentation:
- Passport or Residence Card
- Foreign Higher Education Degree (Graduate, Graduate, Architect, Engineer Doctor...) that give access to own postgraduate degree studies.
- Certificate certifying that the studies carried out give access to an Official Postgraduate Degree in your country of origin, issued by the University of origin
- Curriculum vitae
- Declaration of the person responsible for the veracity of the data provided in digital format
- Any other document that the Director of the Own Title specifically requires for its acceptance
Applicants with studies completed in foreign University Centers may be requested at any time a certificate of verification of these studies and centers, issued by an authorized Institution.
All documentation provided must be legalized in accordance with Spanish law and translated by an official translator.