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PBPK Modeling and quantitative in vitro-in vivo extrapolations

Physiologically based pharmacokinetic (PBPK) modelling plays a crucial role in next generation (non-animal) risk evaluations to inform the design of in vitro studies and to convert the data obtained with in vitro models into human dose−response or potency information. The goal of the course is to acquaint participants with setting up PBPK models based on non-animal input parameters and to subsequently use these models to extrapolate in vitro bioassay data to human dose-response or potency information.

The course consists of:

– Lectures that cover the basic principles of PBPK model-development and the application of PBPK modelling in different fields (e.g. safety evaluations of pharmaceuticals and industrial chemicals, development of alternatives to animal testing).

– Hands-on experience focussing on how to derive adequate chemical-specific input parameters.

– Hands-on experience with developing PBPK models in Berkeley Madonna software.

– Hands-on experience with developing PBPK models with Simcyp’s Population-based Simulator.

– Use of the models to extrapolate in vitro bioassay results to human dose-response or potency information

The training will only take place if minimum of 8 participants is reached.

The training will start with 0.5 day lectures and will be followed by 1.5 days of practical training (Hands on-training) where participants, divided in small groups will get the chance to discuss and interact with the experts. This is a perfect way to quickly approach a software, as well as data analysis and interpretation.

Registration fee includes the participant booklet, catering and social dinner.

Novel In Silico Models for Assessment of Cosmetics - Practical Applications

The course will introduce the use of models relevant for cosmetic ingredients, addressing properties like mutagenicity (Ames test and micronucleus), skin sensitizations, NOAEL, and others for human toxicity. The course will address hazard and exposure, such as skin permeation. New models, developed in the last year, will be also presented.

Questions addressed within the course will be:

  • How to evaluate the reliability of the models?
  • How to compare results from different models?
  • How to identify relevant chemicals for read-across?
  • How to integrate the results from in silico models and read-across?

Besides Mario Negri’s experts, speakers for this training are:

  • Judith C Madden, Liverpool John Moores University talking about “Prediction of Skin Metabolism and its Implication in Toxicity Assessment-Computational”
  • Tao Chen, University of Surrey talking about “in silico modelling of skin permeation”

The training will only take place if a min. of 4 participants is reached

Registration fee includes the participant booklet, catering and social dinner.

The training will start with 0.5 day lectures and will be followed by 1.5 days of practical training (Hands on-training) where participants, divided in small groups will get the chance to discuss and interact with the experts. This is a perfect way to quickly approach a software, as well as data analysis and interpretation.

Registration fee includes the participant booklet, catering and social dinner.

In Vitro Assays Development & Good In Vitro Method Practices

This training will illustrate various aspects of the OECD Good In Vitro Methods Practices (GIVIMP) guidance document (STA 286) using assays/techniques/test systems that have been developed recently by the different trainers. It aims to provide the participants with hands-on, practical skills in how to apply GIVIMP in their daily work in the laboratory, and at the same time learn about modern techniques used for in vitro testing.

Among trainers besides RISE (a polytechnic research institute and member of EU-NETVAL), there will be acCELLerate (a specialist for Assay Ready Cells and Cell Banking), Evercyte and SenzaGen.

Participants will learn among other things:

  • Evaluate robustness of test systems and quality control procedures (AcCELLerate and Evercyte)
  • Choice of test, reference, and control items; solubility verification; development of acceptance criteria (SenzaGen)
  • Method performance and SOP development (RISE)

The training will start with 0.5 day lectures and will be followed by 1.5 days of practical training (Hands on-training) where participants, divided in small groups will get the chance to manipulate and see the critical steps of the methods with the experts. This is a perfect way to quickly approach a method, as well as data analysis and interpretation.

Draft Agenda will be available soon or contact us nathalie.belot@altertox.be

Registration fee includes the participant booklet, catering and social dinner.

In Vitro Lungs Model

This two days hands-on training hosted by Epithelix will cover practical use of respiratory in vitro 3D tissues and exposure devices to evaluate acute and repeated dose inhalation toxicity. To mimic systemic context, interconnection strategies of lung tissues will be presented.

The training will only take place if minimum of 8 participants is reached.

Registration fee includes the participant booklet, catering and social dinner.

The training will start with 0.5 day lectures and will be followed by 1.5 days of practical training (Hands on-training) where participants, divided in small groups will get the chance to manipulate and see the critical steps of the methods with the experts. This is a perfect way to quickly approach a method, as well as data analysis and interpretation.

Registration fee includes the participant booklet, catering and social dinner.

Acute and chronic cardiotoxicity

The course is a two-day laboratory workshop in Leiden. This training instructs the attendee in best practices procedures for in silico and in vitro assays related to acute and chronic cardiotoxicity.

Participants will learn among other things:

  • Regulatory context to apply these methodologies as well as strengths, weaknesses and future prospects (UCB – Dr Delaunois)
  • Cell handling of human iPSC-derived cardiomyocytes (e.g. thawing procedure, cells seeding) (NCardia)
  • Preparation of cryopreserved hiPSC-derived cardiomyocytes in 48/96 or 348 well plates (NCardia)
  • Exposure of cells with cardiotoxic compounds using different readouts such as CiPA-like MEA (Micro-electrode array) and calcium flux assay (NCardia)
  • Risk Assessment, validation, analysis interpretation and decision making using hiPS-cells for early drug discovery and development (Jannsen Pharma – Dr. Kreir)
  • In silico assessment of the effects of various compounds in MEA/hiPSC-CM assays: modelling and numerical simulations (inria)

The training will start with half day lectures and will be followed by 1.5 days of practical training (Hands on-training) where participants, divided in small group will get the chance to manipulate and see the critical steps of the methods with the experts. This is a perfect way to quickly approach a method, as well as data analysis and interpretation.

Draft Agenda will be soon available.

The training will only take place if a minimum of 4 participants is reached.

Registration fee includes the participant booklet, catering and social dinner.

Evaluation du potentiel irritant oculaire in vitro des ingrédients et produits cosmétiques finis en Europe: les tests valides et validés.

  • Fee-based
  • 21 novembre 2019
  • Lyon, France
  • Aborder la procédure générale de l’évaluation du risque
  • Présenter le statut actuel de la validation des méthodes alternatives en Europe (Règlement CE 1223/2009) et les recommandations internationales (OECD Test Guidelines)
  • Présenter les tests validés pour les ingrédients cosmétiques et les tests valides pour les produits cosmétiques
  • Appréhender les avantages, les inconvénients et les limites de chaque méthode d’essai

La formation aura lieu s’il y a au moins 5 participants inscrits.

Skin Sensitization

At this two-days training, experts will put emphasis on sensitization models and skin sensitization quantitative risk assessment. Introduction and application of validated methods (DPRA, LuSens), a coculture model (COCAT), in silico integrating tools and their application in risk assessment will be demonstrated. The training will focus on data assessment, testing strategies and their use in skin sensitization quantitative risk assessment.

Among future trainers besides Trier University, there will be BASF, Coty (to be confirmed), Edelweiss Connect.

The participants will learn among other things:

  • Alternatives to animal testing to assess sensitization potential and potency (Dr B. Blömeke – Trier University)
  • Introduction to skin sensitization validated methods (OECD TG 442C, TG 442D and TG 442E) (BASF)
  • COCAT – A HaCaT/THP-1 coculture model to estimate skin sensitization potential and potency in vitro (Trier University)
  • Quantitative risk assessment-case study (Coty)

The training will start with half day lectures and will be followed by 1.5 days of practical training (Hands on-training) where participants, divided in small groups will get the chance to manipulate and see the critical steps of the methods with the experts. This is a perfect way to quickly approach a method, as well as data analysis and interpretation.

Draft Agenda will be soon available.

Registration fee includes the participant booklet, catering and social dinner.

Evaluation du potentiel irritant oculaire in vitro des ingrédients et produits cosmétiques finis en Europe: les tests valides et validés.

  • Fee-based
  • 19 Mars 2020
  • Lyon, France

https://www.eventbrite.com/e/evaluation-du-potentiel-irritant-oculaire-in-vitro-des-ingredients-et-produits-cosmetiques-finis-en-tickets-65413133443

contact us for more info

+32 (0)485 52 39 45