Corso organizzato in collaborazione con Die Akademie Fresenius
2-3 novembre 2023
IUCLID per prodotti fitosanitari: una guida pratica
Presentation of the course:
This training will provide you with the basic knowledge on how to make PPP-related submissions in IUCLID. You will learn about the basic characteristics and functions of the IUCLID Software, how to use IUCLID for submissions in the working context of PPPs and how to complete a study record for each IUCLID Section.
This course is aimed at professionals working in the fields of Regulatory affairs, Registration, Exposure assessment, Risk assessment and Toxicology in the sector of Plant protection industry and Scientific and regulatory consultancies
Programme:
The course will cover the following topics:
- Basic and general characteristics of the IUCLID software: Scope of the software, download, differences in local, server and cloud instalments, User, legal entity, rights, General elements of the software, meaning of the different entities:
- Substance
- Dossier
- Mixture/Product
- Reference substance
- Test material
- Templates
- Literature
- Overview of guidance and manuals (IUCLID for PPP)
- IUCLID – Basic functions
- Creation of the different entities: mandatory and optional fields
- Difference and compilation of the different sections between endpoint and summaries
- Key study, supporting study
- QSAR, QMRF, QPRF
- Data waiving
- Importing, exporting and backups
- IUCLID for the different submissions
- Working contexts for PPPs
- Confidentiality and sanification
- Reports
- Validations
- Attachments, LoA and other documents
- Creation and submission of the dossier
- Practical case
- Compilation of a study record for each IUCLID section
- Tips and tricks
