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The Participants
The EDQM invites members of the OMCL network having expertise in the field of interest to be participants in a collaborative study on a voluntary basis. In addition, usually all companies whose product(s) are subject of the project, and whose product(s) is (are) commercialised in Europe are invited to participate in the collaborative trial.
Non-European national control laboratories or interested manufacturers might also be invited to participate to foster international harmonisation of methods and reference materials. If too many laboratories volunteer to participate, it might be necessary to limit the number of participants.
The Project Leader
The Project Leader is a scientific expert in the field, generally from an OMCL. In general, his/her role is to provide scientific assistance to a specific BSP project.
The Donators of Materials
The EDQM/ DBO approaches manufacturers of suitable products (i.e. products present on the European market) for donation of materials (e.g. candidate BRP batches, reagents, samples) and any relevant information on the quality and safety of these materials (e.g. certificate of analysis, detailed batch records, stability data, material safety data sheet). If requested by the manufacturer, EDQM provides a Council of Europe document which allows the manufacturer to re-claim national taxes (e.g. VAT).
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