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EMA
Managing a Global Publishing Strategy
Having an electronic submission strategy in place is critical in supporting the transition to eCTD. Advanced planning and an understanding…
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Paediatric
Paediatric Investigation Plan: Requirements, process, and comparison with US PSP
A Paediatric Investigation Plan is on the critical path to obtain market approval in Europe, even if the condition does…
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Clinical Trials
Initiating Clinical Trials in the EU: Current Scenario and Upcoming Changes
With 28 member states and associated countries, initiating a clinical trial in the EU is perceived by many in the…
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