Sentence examples for dossier quality from inspiring English sources

Exact(1)

It has been almost a year since I have been working as a scientist in RA, and as the lead clinical RA specialist, I have found a healthy mix of being connected with the research as well as being exposed to and responsible for project delivery, dossier quality, and response to questions by various regulatory agencies (e.g., the Food and Drug Administration and Health Canada).

Similar(58)

Individual stakeholders generally putting into question the quality of dossiers are rather counterproductive in this joint learning process.

If that is the case, many orphan drugs will not reach the market because the sponsor will not be able to show evidence of favourable characteristics of the product due to the poor quality of the dossier.

Although we, and also ECHA [2] are not completely satisfied with the quality of many dossiers and the way the information requirements were interpreted, we'd like to congratulate the world-wide chemical industry for managing this challenge in time.

Quality control processes like dossier evaluation, substance evaluation and regulatory processes like SVHC identification, authorisation and restriction have just started.

Registrants are requested to take over their responsibility for compliance and quality of the registration dossiers and the assessments.

The focus of industry may shift to improving the quality of the registration dossiers and SDS when these more time-consuming processes are completed.

To assure a safe use of chemicals, manufacturers, importers and downstream users need to take over the responsibility for compliance and quality of the registration dossiers and the assessments including risk management.

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 an interview, Mr. Gharani's lawyer, Clive Stafford Smith, called the quality of the information in the dossier "drivel".

Areas where support was requested included dossier evaluation and review, development of protocols and Standard Operating Procedures, quality management systems and post market monitoring and surveillance.

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