Aim of the course
This new course is intended for (registered) toxicologists who would like to keep up to date on the latest developments in the field of toxicology. In 1.5-day, new insights and perspectives in key current topics in toxicology will be presented. The novelty of this course is that new topics will be covered each year, aiming to make the course a reference amongst toxicologists seeking to keep up to date within the different areas of toxicology.
Content and outcomes of the course
To assure that all participants have the required basic knowledge in the topics, literature will be shared before the beginning of the course. The course will consist of 3-dayparts, namely an afternoon and subsequent evening and morning. The first day part will focus on New Developments in Human Based Models and the evening program will focus on Endocrine Disruptors. The last daypart in the morning of the second day will be entitled Safe-by-Design, focusing on the testing for safety of compounds/materials during the development process. An overview of the schedule and program is given below.
Day 1: December 2nd, 2021
12:00 – 13:15 Lunch
13:15 – 17:00 Topic 1: New Developments in Human Based Models
17:00 – 18:00 Drinks & networking
18:00 – 20:00 Dinner
20:00 – 22:00 Topic 2: Endocrine Disruptors
Day 2: December 3rd, 2021
07:30 – 08:45 Breakfast
08:45 – 12:30 Topic 3: Safe-by-Design
12:30 – 13:00 Lunch in the room
Topic 1: New Developments in Human based Models
Presenter: Prof. dr. Roos Masereeuw (Utrecht University)
Aim: To teach participants the state-of-the art in advanced in vitro models that allow to study human toxicology.
Overview/Content: Societal and scientific pressures demand for careful consideration and revision of the current animal experimentation used for toxicological hazard and risk assessment purposes. With this in mind, researchers have developed a large variety of novel models with the aim to mimic human physiology. These models range from simple, one cell cultures to complex, multiorgan systems cultured under flow conditions. Although scientifically advanced, their broader use is still limited. This is in part because market introduction is not always a researcher’s primary focus, but also because a lack of knowledge on validation and implementation gaps market introduction. In addition, regulatory frameworks need to adapt their guidelines and acquire trust in novel models. Here, challenges in development, and validation of advanced in vitro models and their potential to contribute to the 3R’s (reduction, refinement and replacement) will be addressed, particularly in the context of hazard and risk assessment requirements.
Method: After an introduction into the state-of-the-art of human based models, the participants will have a working group assignment in which several aspects around validation and implementation of a recently developed model by stakeholders will be discussed.
Outcome: At the end of the workshop the participants will have an overview of current developments in advanced in vitro modelling for replacement of animal studies.
Topic 2: Endocrine Disruptors
Presenter: Prof. dr. ir. Juliette Legler (Utrecht University)
Overview/Content: The possible negative effects to human and environmental health of exposure to endocrine disruptors is a growing concern in the EU and worldwide. European legislation aimed at phasing out endocrine disruptors in water, industrial chemicals, plant protection products and biocides has been introduced. For some legislation, the Commission has developed science-based criteria to identify endocrine disruptors, based on a chemical’s endocrine mode of action and related adverse effects relevant for human health. The current test methods to identify EDCs have focused mainly on well-studied endocrine pathways in the estrogen, androgen and thyroid systems. However, there are no regulatory in vivo or in vitro tests to identify other endocrine effects, such as effects on insulin regulation or neurodevelopment. The absence of harmonised criteria and comprehensive testing strategies poses challenges for the identification of endocrine disruptors across sectors. Furthermore, the use of hazard-based criteria for identifying endocrine disruptors within a hazard-based vs a risk-based approach to decision making is still disputed.
Method: After a brief introduction to the topic, we will organise a debate on endocrine disruptors, in which the role of different stakeholders, including representatives from business associations, academic institutions, public and authorities and citizens, will be examined.
Outcome: At the end of the session, participants will have a better understanding of the most relevant current topics in ED testing and regulation.
Topic 3: Safe-by-Design
Presenter: Dr. Margriet Park (RIVM)
Aim: To teach participants the basics of creating societal robust and safe innovative products.
Overview/Content: Advanced technologies such as biotechnology and nanotechnology create exciting new opportunities for product development in many branches of industry. For example, biotechnology offers possibilities to produce renewable raw materials for chemicals and fuels while nanomedicine provide better options for diagnosis and treatment of diseases.
A critical success factor in the implementation of any type of new technology is that its safety for society, human health and the environment is adequately governed. However, the potential risks of a new chemical or material are generally addressed only in a relatively late stage of the research and development process, when the product is already close to market. In addition, regulatory frameworks need time to adapt their governance of novel products, especially if the innovation leads to large uncertainties in societal, human and environmental health risks.
Method: After an introduction into the (developing) concepts of Safe-by-Design and Safe Innovation, the participants will play an interactive Serious Game, revolving around a fictive case of an innovative product.
Outcome: At the end of the workshop, participants have learnt what potential risks need to be considered and how they can be addressed at an early stage of product research and development.
Coordinator: Prof. dr. ir. Juliette Legler and Prof. Dr. Flemming R. Cassee, Utrecht University
Duration: 1.5 days
Credits: 3 CPD credits (Continuing Professional Development)
Fee: € 750,- including overnicht stay, breakfast, 2x lunch and dinner or € 690,- without overnicht stay and breakfast.
Location: Congress Centrum Woudschoten, Zeist