Developing a target; Regulatory writing tips; Templates and style guides: The nuts and bolts of regulatory documents; Document review; Protocols; Clinical study reports; Investigator's brochures; Investigational medicinal products dossier; Integrated summaries of safety and efficacy; Informed consent forms; Global submissions: The common technical document; Clinical trial procedures and approval processes in Japan; Region-specific submissions: United States of America
Summary
Shows you how to approach the writing task in a logical process that permits rapid completion of writing. This book covers specific documents types, as well as submission to various major regions of the world
