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This short course will provide a practical overview of the key requirements and processes involved in delivering a regulatory submission package for a New Drug Application (NDA) and/or Marketing Authorization Application (MAA). In addition to presenting an overview of the fundamental regulatory document requirements (Clinical Summaries, Clinical Overview, etc.), the course will recommend ‘best practice’ processes and discuss the importance of agreeing a clear submission plan and scientific strategy. However, even when regulatory requirements are fully understood and ‘best practice’ approaches are followed, submissions may often deviate from the initial plan and strategy. Therefore, this course will also present a number of anonymized case studies to illustrate the challenges that may be faced and allow delegates to discuss approaches to avoid – or at least to mitigate and manage – such challenges. Although delivered from the perspective of a medical writer, this course will also be of relevance to regulatory professionals, clinical project managers, and other members of the clinical/regulatory team involved in submission delivery.
At the conclusion of this short course, participants should be able to:
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