TOXICOLOGIST

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EU and FDA Advance Reduction of Animal Testing in Drug Development

Want to learn how to prepare submission dossiers for EU agencies, or get familiar with the platforms behind real regulatory data? You don’t need an expensive course to get started. There is a growing range of free, official resources — provided directly by ECHA, EFSA, and the EU Academy — that let you practice with the same tools used in real submissions, at no cost.

Below is a curated overview of the tools and courses I’ve used to build up my own regulatory toxicology skills, organized by platform and use case.


1. ECHA Cloud Services — Trial Access to IUCLID 6

ECHA Cloud Services offers a trial version of IUCLID 6, designed for users who want to get familiar with the platform before committing to the full IUCLID Cloud service.

Through the trial, you can also explore a trial version of the ECHA Submission Portal, which gives access to training versions of:

  • CLP Poison Centre Notification
  • SCIP Notification
  • EFSA Application Submission

Important: submissions made in the trial environment are not treated as real data and cannot be used to fulfil legal obligations — this is purely a sandbox for learning the interface and workflow.


2. CHESAR — Chemical Safety Assessment and Reporting Tool

CHESAR (version 3.9.1) is a free application developed by ECHA to support chemical risk assessment and documentation, relevant to both REACH and the Biocidal Products Regulation.

If you want to see how CHESAR integrates with IUCLID Cloud in practice, ECHA has a walkthrough video available here: How to connect CHESAR with IUCLID Cloud


3. OECD QSAR Toolbox

For anyone working with predictive toxicology or read-across approaches, the OECD QSAR Toolbox is freely available and worth exploring alongside the above tools — particularly useful if your work touches on non-animal or NAM-based hazard assessment.


4. ECHA’s YouTube Channel

ECHA maintains an extensive library of webinars covering IUCLID, REACH, and related regulatory topics, organized into playlists: ECHA YouTube — Playlists

This is a good ongoing resource to bookmark, since new webinars are added as regulations and platform features evolve.


5. EU Academy — Free Self-Paced Courses

The EU Academy hosts several free, self-paced courses directly relevant to dossier preparation and evaluation. All include video tutorials and official guidance documents.

IUCLID for Applicants

Course link

Covers the key steps in dossier preparation and submission, including:

  • Introduction to ECHA Cloud Services and IUCLID desktop/server
  • IUCLID governance and release schedule
  • ECHA accounts and legal entities
  • IUCLID dossier basics: PPP working contexts, dossier preparation, microorganisms, Table of Contents, datasets, IUCLID documents
  • Making a request for confidentiality and instructions for uploading attachments
  • Using the validation assistant and resolving validation rule errors
  • Report generator and an overview of available reports
  • Transparency Regulation publication requirements
  • Creating and exporting a dossier (including the “light” dossier export)
  • The Submission Portal

IUCLID for Evaluators

Course link

Focused on dossier admissibility and evaluation:

  • Introduction to ECHA Cloud Services
  • IUCLID dossier basics: dossier structure, working contexts, and crosswalks
  • Dossier components and submission
  • Admissibility, including Notification of Studies obligations
  • Dossier evaluation
  • Using IUCLID tools to check, compare, and review confidentiality claims, and to generate reports

Target audience: professionals working within pesticide regulatory authorities in Europe (Rapporteur/Evaluating Member States, European Commission) involved in the admissibility and/or evaluation of pesticide IUCLID dossiers.

By the end of this course, you’ll be able to:

  • Navigate an IUCLID dossier and locate key information
  • Complete the steps for an admissibility check
  • Use IUCLID’s built-in tools for checking, comparing, and reviewing confidentiality claims, and generating reports

Online Resources for Applicants: The EFSA Toolkit and Application Procedures Webpage

Course link

This course introduces two key EFSA resources for applicants working on food-regulated products:

  • The EFSA Toolkit — guidance on the IT platforms used across different stages of the application process, including Connect EFSA, Open EFSA, and the submission portals ESFC, IUCLID, and Portalino.
  • The Application Procedures webpage — a comprehensive overview of the application process across all food-regulated areas, including applicable regulations, guidance documents, and tools.

Target audience: applicants preparing dossiers in any food-regulated area involving EFSA scientific assessment — particularly useful for SMEs and first-time applicants, but also relevant for experienced applicants, consultants, industry associations, and other stakeholders.

By the end of this course, you’ll be able to:

  • Identify the key EFSA online resources supporting application preparation
  • Understand the role of each platform at different stages of the application process
  • Know when and how to use Connect EFSA for questions and pre-submission advice
  • Understand how Open EFSA is used to follow the life cycle of an application and EFSA’s scientific work
  • Recognise the purpose of ESFC, Portalino, and IUCLID for submitting applications
  • Navigate the Application Procedures section of EFSA’s website for guidance relevant to your regulated area

Quick Reference Table

Tool / CourseProviderBest for
ECHA Cloud Services (IUCLID 6 Trial)ECHAGetting hands-on with IUCLID before real submissions
ECHA Submission Portal (Trial)ECHAPracticing CLP, SCIP, and EFSA submission workflows
CHESARECHAChemical risk assessment under REACH/Biocidal Products Regulation
OECD QSAR ToolboxOECDPredictive toxicology, read-across, NAM-based hazard assessment
ECHA YouTube PlaylistsECHAOngoing training on IUCLID, REACH, and related topics
IUCLID for ApplicantsEU AcademyDossier preparation and submission (applicant perspective)
IUCLID for EvaluatorsEU AcademyDossier admissibility and evaluation (regulator perspective)
EFSA Toolkit & Application ProceduresEU AcademyNavigating EFSA’s submission platforms for food-regulated products

All of the above are free and self-paced, meaning you can build a solid working knowledge of EU regulatory submission tools entirely on your own schedule — no prior enrollment or institutional access required.

Found this useful? Follow along on the Toxicologist for more resources on regulatory toxicology, NAMs, and evidence-based risk assessment.

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