About this book
The secrets of regulatory writing for clinical documents in the drug and biologics industry in the 3 major regions of the world (Europe, Japan, and the United States) are revealed in this book. From organizing the writing process through securing the final signatures, the authors describe how to determine which document is needed (developing the target), how to start the process using writer’s tools (templates and style guides), how to write individual documents (protocols, study reports, investigator’s brochures, and integrated summaries, to name a few), and how to navigate review and sign-off. Details of writing each section of a document, and the relationship among documents is discussed, from the perspective of an efficient and timely writing process. Lessons learned are included in each chapter, describing real-life scenarios in the industry.
This book will be helpful for beginning medical writers, as well as writers with more experience who are interested in improving their skills. It is the first comprehensive book of regulatory writing for this industry, covers specific document types, as well as submissions to all major regions of the world, for drugs and biologics, and is written by 2 regulatory writers with more than 20 years experience each.
Value-added features include extensive appendices of sample documents and a comprehensive glossary of terms.
Written for: Regulatory writers and project managers in the pharmaceutical and biotech industry; regulatory affairs professionals; scientific libraries