External Auditor Required for Bovine TB Vaccine Field Trials Phase 3
The requirement is for the current external auditor to be based on the extended field work to complete Phase 3 of the field trials. Defra have invested in the development of a vaccine and companion DIVA test for bovine TB and it is expected that these will be a key tool in the control of this disease. For granting of a…
Source ID: UK-ocds-b5fd17-b362e58a-9a59-436a-a458-95a271f9df95
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Scope overview
The requirement is for the current external auditor to be based on the extended field work to complete Phase 3 of the field trials. Defra have invested in the development of a vaccine and companion DIVA test for bovine TB and it is expected that these will be a key tool in the control of this disease.
For granting of a Marketing Authorisation (MA) by VMD a field trial of both diagnostics demonstrating safety and specificity must be run in the field. The external auditor will ensure that the field trial complies with GCPvet by performing audits as well as providing consultancy as and when required. Any significant deviation from GCPvet would risk granting of the MAs, and the field trial having to be repeated.
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