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A dossier containing a testing proposal is automatically considered for dossier evaluation.
To verify the quality and compliance of registrations, REACH introduced the instrument of dossier evaluation.
The dossier evaluation is ongoing and 427 dossiers have been checked for compliance by the end of 2012 [1].
ECHA's current approach in dossier evaluation shifts to a targeted approach, namely selecting specific points of concern.
One element of dossier evaluation is the examination of testing proposals (TPE) received with the registration dossiers.
Quality control processes like dossier evaluation, substance evaluation and regulatory processes like SVHC identification, authorisation and restriction have just started.
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Pharmaceutical manufacturers have to submit a benefit dossier for evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG).
The G-BA decision is based on the manufacturers' dossier, IQWiG evaluation, as well as the results of a public hearing.
To date, the application of chlorpyrifos for biocidal purposes is not allowed because industry did not submit a dossier for evaluation.
Evaluation comprises dossier and substance evaluation to ensure high quality of the registrations, and to remove data gaps and identify risks which need further regulation.
In this article the study designs currently accepted for the nonclinical safety testing of new vaccines are described for single dose, local tolerance, repeat dose toxicity and safety pharmacology studies; these studies together form the basis of a typical nonclinical safety evaluation dossier.
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CEO of Professional Science Editing for Scientists @ prosciediting.com