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Targeted Regulatory Writing Techniques
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Table of Contents

Regulatory writing fundamentals.- Developing a target.- Getting started.- Regulatory writing tips.- Templates and style guides: The nuts and bolts of regulatory documents.- Document review.- Source documents.- Protocols.- Clinical study reports.- Integrated documents.- Investigator's brochures.- Investigational medicinal products dossier.- Integrated summaries of safety and efficacy.- Informed consent forms.- Regulatory submissions.- Global submissions: The common technical document.- Clinical trial procedures and approval processes in Japan.- Region-specific submissions: United States of America.

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