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Once agreed upon with CSO Project Team actors (3-6months ahead of M2), the OPCM CSO is the single accountable person for the accuracy of the entered plan and regular updates in the planning tool (Planisware solution). The OPCM CSO ensures that the clinical operational plan reflects the project...

For each assigned therapeutic project (synthetic or biologic molecule) and once agreed with the CMC Project Team actors, the CMC OPCM is the single accountable person for the accuracy of the entered plan and regularly updated in the planning tool (Planisware solution). The CMC OPCM ensures that the...