Participate in a BSP Study
Who Can Participate ?
The EDQM invites General European OMCL Network (GEON) members having expertise in the field of a collaborative study to voluntarily participate. Usually all companies whose product(s) are subject of a study, and whose product(s) are commercialised in Europe are invited to participate.
To foster international harmonisation of test methods and reference standards, non-European national control laboratories or interested manufacturers may also be invited to participate. If too many laboratories volunteer to participate, it can be necessary to limit the number of participants.
Participating laboratories are not permitted to subcontract any part of their duties to other laboratories, unless it has been pre-approved by the EDQM.
Act as a Project Leader
The Project Leader is a scientific expert in the field of a given collaborative study and comes generally from an OMCL. His/her role is to provide scientific assistance to the study.
Act as a Scientific Advisor
In cases where an already existing study protocol can be applied (e.g. for replacement batches of biological reference preparations (BRPs), the project is co-ordinated by the EDQM. However, Scientific Advisors can be involved to give advice.
The EDQM approaches manufacturers of biological medicinal products present on the European market and relevant manufacturers' associations for donations of material.
Donated material should be fully documented in terms of quality and safety (e.g. certificates of analysis, detailed batch records, stability data, safety data sheets [SDS]).