Training courses offer

SK-NETVAL Practical Training Programme

Hands-on Training in Regulatory NAMs: Cell Culture, 3D Tissue Models and OECD/ISO Test Methods

  1. work with cell lines and reconstituted 3D tissue cultures – handling the cultures
  2. training for conducting studies according to OECD TG 431 – skin corrosion
  3. training for conducting studies according to OECD TG 439 – skin irritation
  4. training for conducting studies according to OECD TG 492 – eye irritation
  5. training for conducting studies according to OECD TG 432 – phototoxicity, cell lines
  6. training for conducting studies according to OECD TG 498 – phototoxicity, 3D models
  7. training for conducting studies according to ISO 10993-5 – biocompatibility tests, cell cultures
  8. training for conducting studies according to ISO 10993-23 – biocompatibility tests, 3D models
  9. training for conducting local tolerance studies of preparations – 3D skin and corneal model
  10. training for ELISA tests and determinations of IL1-a and TNF for the above-mentioned tests

Certificate and course combination:

Each training course module concludes with a Certificate of Completion. Depending on the participants’ needs, background and training objectives, selected courses may be combined into a tailored training programme. The most appropriate combination, scope and duration of the training should be discussed and agreed with the organisers in advance.

For more information please do not hesitate to contact the coordinator of the SK-NETVAL training:
Dr. Helena Kanďárova, ERT, helena.kandarova@savba.sk

Details of the courses and learning objectives

1. Handling of Cell Lines and Reconstructed 3D Tissue Models

Duration: 1 day
Learning objectives:
Upon completion of the course, participants will be able to:

  • apply good cell and tissue culture practices for routine handling of cell lines and reconstructed 3D tissue models;
  • perform appropriate culture maintenance, media preparation, feeding, passaging and tissue handling;
  • recognize common sources of contamination, variability and culture failure;
  • document culture conditions and procedures in accordance with good laboratory practice and GIVIMP principles.

2. OECD TG 431 – In Vitro Skin Corrosion

Duration: 1,5 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • explain the scientific principle and regulatory purpose of OECD TG 431;
  • prepare reconstructed human epidermis models and test materials for skin corrosion testing;
  • conduct the assay according to OECD TG 431, including exposure, washing, viability assessment and controls;
  • calculate, interpret and report results and determine the appropriate skin corrosion classification.

3. OECD TG 439 – In Vitro Skin Irritation

Duration: 3 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • understand the biological basis and regulatory application of OECD TG 439;
  • perform skin irritation testing using reconstructed human epidermis models;
  • conduct test substance application, post-exposure incubation and tissue viability measurements;
  • evaluate assay acceptance criteria and interpret results for hazard classification.

4. OECD TG 492 – Reconstructed Human Cornea-like Epithelium Test Method for Eye Irritation

Duration: 2,5 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • explain the principles and applicability domain of reconstructed human cornea-like epithelium models for eye irritation testing;
  • correctly handle corneal epithelial tissues and perform exposure and post-exposure procedures;
  • conduct viability measurements and assess assay validity;
  • interpret and report results in accordance with OECD TG 492 requirements.

5. OECD TG 432 – In Vitro 3T3 NRU Phototoxicity Test

Duration: 3 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • explain the mechanisms underlying chemically induced phototoxicity and the principle of the 3T3 NRU phototoxicity test;
  • perform cell-based phototoxicity testing under appropriate irradiation and non-irradiation conditions;
  • measure neutral red uptake and generate concentration-response data;
  • evaluate and interpret phototoxicity using appropriate parameters, including PIF and MPE.

6. OECD TG 498 – Phototoxicity Testing Using Reconstructed Human Epidermis

Duration: 3 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • explain the principles and regulatory context of phototoxicity assessment using reconstructed human skin models;
  • prepare and expose 3D tissues to test substances under controlled irradiation conditions;
  • assess tissue viability and relevant assay controls and acceptance criteria;
  • analyse and interpret results according to OECD TG 498 and prepare appropriate study documentation.

7. ISO 10993-5 – In Vitro Cytotoxicity Testing of Medical Devices

Duration: 3 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • understand the role of in vitro cytotoxicity testing within the biological evaluation of medical devices;
  • select and prepare appropriate test samples and extracts according to relevant ISO requirements;
  • perform cytotoxicity testing using cell cultures and suitable viability endpoints;
  • evaluate, interpret and document results according to ISO 10993-5.

8. ISO 10993-23 – Irritation Testing Using Reconstructed 3D Models

Duration: 3 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • understand the principles of irritation assessment of medical devices according to ISO 10993-23;
  • prepare medical device extracts and appropriately handle reconstructed 3D tissue models;
  • conduct irritation testing, including exposure, incubation and viability measurements;
  • assess assay validity, interpret results and prepare study documentation suitable for biological evaluation.

9. Local Tolerance Assessment Using 3D Skin and Corneal Models

Duration: 3 days
Learning objectives:
Upon completion of the course, participants will be able to:

  • understand the principles of local tolerance assessment for pharmaceutical, cosmetic or other formulations;
  • select an appropriate reconstructed skin or corneal model based on the intended route of exposure and study objective;
  • design and conduct local tolerance studies using relevant viability, barrier integrity, morphological and inflammatory endpoints;
  • integrate multiple endpoints to assess local effects and interpret the biological relevance of the findings.

10. ELISA and Determination of IL-1α and TNF-α

Duration: 1 day
Learning objectives:
Upon completion of the course, participants will be able to:

  • explain the principles of ELISA-based cytokine quantification and its application in in vitro toxicology;
  • appropriately collect, process, store and prepare samples from cell and 3D tissue culture studies;
  • perform ELISA assays for IL-1α and TNF-α, including preparation of standards, controls and calibration curves;
  • calculate cytokine concentrations, assess assay quality and interpret inflammatory responses in combination with other study endpoints.