Titel: Targeted Regulatory Writing Techniques : Clinical Documents for Drugs and Biologics
Verlag: Birkh�user
Erscheinungsjahr: 2008
Sprache: Englisch
ISBN-10: 3764383615
ISBN-13: 9783764383619
Einband: Softcover
Zustand: As New

�ber diesen Titel

Inhaltsangabe

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.

Rese�a del editor

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.

��ber diesen Titel� kann sich auf eine andere Ausgabe dieses Titels beziehen.

Anbieterinformationen

SuperBookDeals.com is your top source for finding new books at the absolute lowest prices, guaranteed ! We offer big discounts - everyday - on millions of titles in virtually any category, from Architecture to Zoology -- and everything in between. Discover great deals and super-savings, on professional books, text book titles, the newest computer guides, or your favorite fiction authors. You'll find it all - at HUGE SAVINGS - at SuperBookDeals. Browse through our complete online product catalog today. Serving customers around the world for years, we help thousands find just the books they're looking for -- at incredibly low, bargain prices.

Zur Homepage des Verk�ufers

Unternehmensdaten des Verk�ufers

Expert Trading Limited
9220 Rumsey Road, Suite 101, Columbia, MD, 21045, U.S.A.

Gesch�ftsbedingungen und Versandinformationen

Verkaufsbedingungen

Company Name: GreatBookPrices
Legal Entity: Expert Trading, LLC
Address: 6310 Stevens Forest, suite 200, Columbia MD 21046
Email address: CustomerService@SuperBookDeals.com
Phone number: 410-964-0026
consumer complaints can be addressed to address above
Registration #: 52-1713923
Authorized representative: Danielle Hainsey

Widerrufsbelehrung

Versandbedingungen

Our warehouses across the globe are fully operational without substantial delays. We are working hard and continue to overcome the daily challenges presented by COVID-19. We appreciate your understanding. ****

Internal processing of your order will take about 1-2 business days. Please allow an additional 4-14 business days for Media Mail delivery. We have multiple ship-from locations - MD,IL,NJ,UK,IN,NV,TN & GA

Versandkosten innerhalb von USA

Versandkosten innerhalb von USA
Bestellmenge	8 bis 14�Werktage	5 bis 14�Werktage
Erster Artikel	EUR 2.28	EUR 2.28

Die Versandzeiten werden von den Verk�uferinnen und Verk�ufern festgelegt. Sie variieren je nach Versanddienstleister und Standort. Sendungen, die den Zoll passieren, k�nnen Verz�gerungen unterliegen. Eventuell anfallende Abgaben oder Geb�hren sind von der K�uferin bzw. dem K�ufer zu tragen. Die Verk�uferin bzw. der Verk�ufer kann Sie bez�glich zus�tzlicher Versandkosten kontaktieren, um einen m�glichen Anstieg der Versandkosten f�r Ihre Artikel auszugleichen.