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Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.

transfer of the analytical methods for those tests that will be performed by the OMCL. Regarding the set of the tests to be performed by the OMCL, this is finally decided by EDQM and depends whether or not ...

Future use of Micro-arrays in enforcement

Publication Type: Scientific poster, presentation or proceeding Authors: Marc Van den Bulcke Source: Trace meeting: TRACE DISSEMINATION WORKSHOP ON "MOLECULAR BIOLOGY METHODS FOR TRACEABILITY ...

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.

responsibility to choose an OMCL belonging to the OMCL network. This choice, which is free, should be made before filing of the MA application. The initial process involves the transfer of the analytical methods ...

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