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- Define the documents required to support an NDA/MAA submission and be able to describe the fundamental purpose of each of these documents and the key procedural steps required to prepare these documents
- Explain the importance of defining a clear and detailed scientific strategy for a submission and promote practical approaches to agree such strategy with the cross functional submission team
- Evaluate potential risks and pitfalls when planning for a submission, recognize when things are not going to plan during submission preparation, and have strategies in place to deal with deviations from the submission plan