Targeted regulatory writing techniques: clinical documents for drugs and biologics

The secrets of regulatory writing for clinical documents in the drug and biologics industry in 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, how to start the process using writer’s tools like templates and style guides, how to writeindividual documents, and how to navigate review and sign-off. Details of writing each section of a document and the relationship among documents are discussed. Lessons learned are included in each chapter, describing real-life scenarios in the industry. This book is 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, covering specific document types, as well as submissions to all major regions of the world. Itis written by two regulatory writers with more than 20 years experience each.Covers specific document types and submissions for drugs and biologics in Europe, Japan and the US Extensive appendices of sample documents Comprehensive glossary of terms Written by two regulatory writers with more than 20 years experience each INDICE: Introduction.- Worldwide regulatory environment (US, Europe, Japan).- General submission principles.- Product classification.- Phases of productdevelopment.- Content.- Getting started.- Integrated documents.- Source documents.- Appendices.

• ISBN: 978-3-7643-8361-9
• Editorial: Birkhaüser
• Encuadernacion: Rústica
• Páginas: 300
• Fecha Publicación: 01/10/2008
• Nº Volúmenes: 1
• Idioma: Inglés