eCTD Life Cycle Management - National and Global - Integration of national requirements in global life cycle management

This seminar will address peculiarities both in developing and submitting an eCTD within the ICH region and in global eSubmission requirements. It will make you aware of the duties involved in applying for a marketing authorisation in the ICH region and in LATAM, ASEAN, the Middle East and Africa.


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It will also make you especially knowledgeable of your life cycle management duties and provide best-practice tips on how to integrate national requirements in your global life cycle management.


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Ultimately, it will show you how to optimise your regulatory operations and IT support.