Webinar on historical control data for regulatory studies
Background
Historical Control Data (HCD) are data from studies conducted under the same or similar conditions as the toxicity study under assessment. The provision of HCD is a data requirement for pesticides, as established by the European legislation, however their collation, presentation and use are not harmonised. A Scientific Opinion on the ‘Use and reporting of HCD for regulatory studies’ has been developed by the EFSA Panel on Plant Protection Products and their Residues (PPR) with the aim to:
- elucidate the requirements for the use of HCD for interpretation of studies used for regulatory purposes,
- clarify how HCD should be compiled as part of the regulatory dossier and
- assist the interpretation of HCD in the context of the evaluation of regulatory studies.
Objectives of the meeting
The event aimed to introduce the stepwise, quantitative approach developed for the collation, evaluation, and use of HCD. The session also included practical examples illustrating the implementation of this approach, along with the presentation of templates designed to promote harmonisation in data submission.
Contact
Do not hesitate to contact the organising committee at webinars [at] efsa.europa.eu (webinars[at]efsa[dot]europa[dot]eu) for more information.
Documents
Recording
