Regulatory information – A new operating model for procedure management to improve support for evalu
The Agency is introducing a new operating model for the management of evaluation procedures. With the new model procedure managers and procedure assistants will be allocated per product, rather than per procedure, in order to improve the co-ordination of regulatory activities with a product, particularly where multiple regulatory procedures are run in parallel for the same product. The strong procedural focus that has already been achieved with the current model will be maintained and strengthened through the creation of process-focused communities that comprise EMA staff specialising in specific procedures.
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