IUCLID for Applicants
One day
Beginner
Course details
The course covers key steps in dossier preparation and submission:
- Introduction to ECHA Cloud Services and IUCLID desktop/server
- IUCLID governance and release schedule
- ECHA accounts and Legal entities
- IUCLID dossiers basic concepts: PPP working contexts and dossier preparation, microorganisms and Table of Contents, datasets, IUCLID documents, making a request for confidentiality and instructions for uploading attachments
- Using validation assistant and actions in case of unresolved rules Report generator, overview of available reports
- Transparency regulation publication requirement
- Create and export dossier – light dossier export explained
- Submission portal
Target audience
This course is suitable for applicants and consultants who are preparing regulatory dossiers in IUCLID format for submission to regulatory authorities in Europe. The focus is on Pesticides dossier but much of the content would be relevant in other sections.
Learning objectives
On successful completion of this course you will be able to:
- Select the correct tools for preparing an IUCLID dossier
- Prepare a dossier for submission to regulatory authorities in Europe
- Use the tools available in IUCLID to check, compare, summarise, filter for dissemination and submit
Offered by
EFSA is an agency of the European Union set up in 2002 to serve as an impartial source of scientific advice to risk managers and to communicate on risks associated with the food chain.
Schedule
- Welcome
- Introduction to ECHA Cloud Services and IUCLID desktop/server
- ECHA accounts and Legal entities
- IUCLID PPP dossiers basic concepts
- Datasets – product, active substance, other product, other substance
- Steps for dossier submission
