Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

EFSA specialized trainings on certain aspects of food safety risk assessment

LOT 2: Trainings on horizontal scientific assessment methodologies

EFSA is launching several training activities in 2023 to enable the understanding and practical implementation of risk/benefit assessment practices, to strengthen the dissemination of scientific risk assessment Guidance Documents and modeling practices, and to ensure the uptake of Guidance Documents on cross-cutting risk assessment approaches already developed by EFSA. The trainings are intended for members of the EFSA Scientific Committee/Panels, their working groups, EFSA staff, EFSA’s networks, and, if eligible from EFSA’s point of view, other interested parties. 

Training modalities will include on-site training courses at EFSA in Parma (Italy) as well as several virtual trainings such as online seminars, e-learning packages and online tutorials.

If you are interested in making use of this training offer, please register by filling in the corresponding registration form. If EFSA considers you eligible, you will be notified a few days after the registration deadline and will receive further information, such as your log-in data for the e-learning platform, in due time. The online tutorial will be publicly available and requires no registration; the link will be shared here, once the tutorial is online. 

Overview training topics

The following topics will be trained:

1. The EFSA scientific assessment principles and process

  • E-learning: Protocol development
  • Virtual seminar: Protocol development
  • E-learning: Weight of evidence approach
     

2. How to identify, characterize and communicate uncertainties in EFSA’s scientific assessments
 

3. Use of new-approach methodologies (e.g. in-silico and in-vitro tools) in chemical risk assessment

  • E-learning: In-silico models and other relevant modeling approaches
  • Virtual seminar: AOP and approaches for using mechanistic understanding for risk assessment
  • Virtual seminar: Evidence integration in the IATA framework, focusing on the AOP informed IATA approach on NAMs to address the data gaps identified  during the iterative process
     

4. Principles of human health risk-benefit assessment of foods

  • E-learning: The risk-benefit assessment framework 
  • E-learning: Microbiological and toxicological risk assessment
  • E-learning: Risk-benefit assessment outputs, the DALY and perspectives

Upcoming training courses in 2024

More information on upcoming courses and registration.

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  • In-silico models and other relevant modeling approaches

    E-learning under Topic 3: Use of new-approach methodologies (e.g. in-silico and in-vitro tools) in chemical risk assessment

    About this course

    This e-learning training course will introduce the main principles of different structure based in-silico approaches for estimation of mainly human health toxicological endpoints. Statistical and rule base quantitative structure activity models (QSARs) will be introduced and how to assess the outcome of these predictions by using expert review. 

    The second topic is read-across, which is usually applied in case that the toxicological properties of a data poor target compound is predicted from one or several data rich similar source compounds. Recent guidance documents such as the RAAF will be taken into account. The different options for similarity assessments will be outlined as well as the main assessment elements of a read-across assessment. 

    The third concept is TTC (threshold of toxicological concern). This concept is used for unknown compounds occurring at low levels in feed/food.

    Exercises will give the opportunity to train on well-known tools such as the OECD QSAR toolbox or Vega. Three webinars will be offered within the e-learning period to discuss the exercise. 

     

    By the end of the course, participants will be able to:

    • Understand the differences between QSAR, read-across and TTC approaches
    • Understand the applicability domain of different models
    • Apply QSAR models and understand the principle of combining evidence by using different QSAR model types 
    • Understand the principles of expert review to deal with conflicting data
    • Have a first insight into different tools such as the OECD QSAR toolbox and Vega

    Learners will have a two-month period to complete the self-study part of the course (presentations and quizzes). Within the training period three webinars will be offered to discuss the exercises. The course will not be fully completed until the second webinar provided is attended by the learner.

    This course is delivered as a blended learning, a mix of instructor-led activities and e-learnings. It will start and end with a live webinar. Learners will have to complete four e-learnings modules in the meantime.

     

    Who will be admitted?

    This EFSA e-learning is open to members of organisations on the List of Competent Organisations (also known as Article 36 List) that are eligible to receive EFSA’s grants. Registrants from other affiliations are not eligible. EFSA reserves the right to select the trainees from all registered persons. If the number of eligible registrants exceeds the number of available places, the first-come, first served principle will be applied. After the registration deadline, all registrants will be informed, and the selected trainees will receive login data for the e-learning platform.

    Tutors

    • Sylvia Escher (Fraunhofer ITEM)
    • Emiel Rorije (RIVM)
    • Emilio Benfenati (IRFMN)

    Location and date

    Location: online - webinar and e-learnings

    Training period: March 15 - May 15, 2024

    Webinars with tutors: Tbd (dates and times will be communicated to participants in due time)

    Registration and costs

    • Registration is closed.
    • This training is free of charge for those considered eligible by EFSA.

  • Evidence integration in the IATA framework, focusing on the AOP informed IATA approach on NAMs to address the data gaps identified during the iterative process

    Virtual seminar under topic 3: Use of new-approach methodologies (e.g. in-silico and in-vitro tools) in chemical risk assessment

    About this course

    The virtual seminar will introduce the concept of IATA and AOP informed IATA and the role of NAMs to fill the data gaps. Furthermore, some specific new approach methods will be introduced in more detail, including QIVIVE, physiologically based kinetic (PBK) and in-vitro biokinetic modelling approaches, which are in use for in-vitro to in-vivo extrapolation (IVIVE). NAMs will be used to show how they best fit for AOP quantification. In addition, the applicability of in-silico approaches to inform the IATA will be presented as a topic. As integration of data is one main assessment element, the concept of weight of evidence and uncertainty analyses will be introduced and trained using examples. Each of these topics will be presented by means of theoretical lectures, examples and hand-on training for the trainees to gain first own experiences.

     

    Learning objectives

    By the end of this course the participant will

    • have understood
      • how to integrate different NAM data in the AOP informed IATA framework
      • the concept of QIVIVE and the underlying assumptions 
      • limitations and uncertainties
    • be able to understand the current status of NGRA, assess the reliability and relevance of a NAM based hazard assessment and the critical elements to be considered to contextualize NAMs in the iterative IATA process.

     

    Who will be admitted?

    The EFSA virtual seminar is open to members of the EFSA Scientific Committee and Panels as well as to Working Group members, Network members and EFSA staff, furthermore to members of other European agencies or European institutions. Registrants from other affiliations are not eligible. EFSA reserves the right to select the trainees from all registered persons. If the number of eligible registrants exceeds the number of available places, the first-come, first served principle will be applied. After the registration deadline, all registrants will be informed, and the selected trainees will receive login data for the e-learning platform.

    Tutors

    • Sylvia Escher (Fraunhofer ITEM)
    • Emiel Rorije (RIVM)
    • Mirjam Luijten (RIVM)

    Location and date

    • Location: online - virtual seminar
    • Training period: May, 21-24, 2024

    Registration and costs

    • Registration deadline: April 30, 2024. 
    • This training is free of charge for those considered eligible by EFSA.
    • Please click here to get to the registration form of this training.

  • AOP and approaches for using mechanistic understanding for risk assessment

    Virtual seminar under topic 3: Use of new-approach methodologies (e.g. in-silico and in-vitro tools) in chemical risk assessment

    About this course

    Next generation risk and hazard assessment will rely more heavily on mechanistic data and the inclusion of such data in the AOP conceptual framework, or the use of constructs for the systematic review and evaluation of mechanistic evidence. Participants will be trained, using lectures, demonstrations and hands-on examples on why and how AOP should be developed and used in the regulatory context. The training will end by showing some recent examples how AOPs have been already included into regulatory hazard assessment.

     

    Learning objectives

    By the end of this course the participant will

    • have understood
      • the role of the AOPs conceptual frameworks and of other constructs for the integration of NAM data into hazard assessment
      • challenges of quantitative AOPs 
    • be able to
      • use common sources of information like AOP Wiki
      • use NAMs to parameterize AOPs
      • develop and asses AOPs

     

    Who will be admitted?

    The EFSA virtual seminar is open to members of the EFSA Scientific Committee and Panels as well as to Working Group members, Network members and EFSA staff, furthermore to members of other European agencies or European institutions. Registrants from other affiliations are not eligible. EFSA reserves the right to select the trainees from all registered persons. If the number of eligible registrants exceeds the number of available places, the first-come, first served principle will be applied. After the registration deadline, all registrants will be informed, and the selected trainees will receive login data for the e-learning platform.

    Tutors

    • Mirjam Luijten (RIVM)
    • Emiel Rorije (RIVM)
    • Sylvia Escher (Fraunhofer ITEM)

    Location and date

    • Location: online - virtual seminar
    • Training period: 
      • June 4, 2024: 2:00 p.m. - 5:30 p.m.
      • June 5-7, 2024: 9:00 a.m. -12:30 p.m.

    Registration and costs

    • Registration deadline: April 30, 2024. 
    • This training is free of charge for those considered eligible by EFSA.

    Please click here to get to the registration form of this training.

Your contacts at Fraunhofer ITEM

Please do not hesitate to contact us, if you have any questions.

Sylvia Escher

Contact Press / Media

Dr. Sylvia Escher

Training coordinator

Phone +49 511 5350-330

Judith Oumard

Contact Press / Media

Judith Oumard

Contact person for organizational questions

Phone +49 511 5350-135