Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

• Corporate Author: SpringerLink (Online service)
• Other Authors: Wood, Linda Fossati (Editor), Foote, MaryAnn (Editor)
• Format: Electronic eBook
• Language: English
• Published: Basel : Birkhäuser Basel, 2009.
• Subjects: Medicine.; Pharmacy.; Pharmacology.; Biotechnology.; Biomedicine.; Pharmacology/Toxicology.

This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy th...

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.