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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologi
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Located in: Carrollton, Texas, United States
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eBay item number:335290021599
Item specifics
- Condition
- Book Title
- Targeted Regulatory Writing Techniques: Clinical Documents for Dr
- ISBN
- 9783764383619
- Publication Year
- 2008
- Type
- Textbook
- Format
- Trade Paperback
- Language
- English
- Publication Name
- Targeted Regulatory Writing Techniques : Clinical Documents for Drugs and Biologics
- Item Length
- 9.6in
- Publisher
- Springer Basel A&G
- Item Width
- 6.7in
- Item Weight
- 31.7 Oz
- Number of Pages
- X, 238 Pages
About this product
Product Information
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 that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef'ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product's characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Product Identifiers
Publisher
Springer Basel A&G
ISBN-10
3764383615
ISBN-13
9783764383619
eBay Product ID (ePID)
70003383
Product Key Features
Publication Name
Targeted Regulatory Writing Techniques : Clinical Documents for Drugs and Biologics
Format
Trade Paperback
Language
English
Publication Year
2008
Type
Textbook
Number of Pages
X, 238 Pages
Dimensions
Item Length
9.6in
Item Width
6.7in
Item Weight
31.7 Oz
Additional Product Features
Number of Volumes
1 Vol.
Lc Classification Number
Rm300-666
Table of Content
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.
Copyright Date
2009
Target Audience
Scholarly & Professional
Topic
Biotechnology, Pharmacy, Law Enforcement, Pharmacology, Technical Writing
Illustrated
Yes
Genre
Technology & Engineering, Science, Medical, Political Science
Item description from the seller
Seller assumes all responsibility for this listing.
eBay item number:335290021599
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