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Author: Linda Fossati Wood
Publisher: Springer Science & Business Media
ISBN: 3764383623
Category : Medical
Languages : en
Pages : 235
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Book Description
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.
Author: Linda Fossati Wood
Publisher: Springer Science & Business Media
ISBN: 3764383623
Category : Medical
Languages : en
Pages : 235
Get Book Here
Book Description
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.
Author: Gloria Hall
Publisher:
ISBN: 9781947493551
Category :
Languages : en
Pages :
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Book Description
Author: Miriam F. Williams
Publisher: Routledge
ISBN: 1351844202
Category : Psychology
Languages : en
Pages : 157
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Book Description
First Published in 2017. This book examines Texas regulations dating as far back as the Texas Black Codes of 1866 to contemporary Texas Child Care Licensing regulations. It presents case studies that test contemporary African American perceptions of various styles of regulatory writing.
Author: Pieter H. Joubert
Publisher: Springer
ISBN: 3662483165
Category : Medical
Languages : en
Pages : 147
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Book Description
A document may be based on accurate medical and scientific information, follow guidelines precisely, and be well written in clear and correct language, but may still fail to achieve its objectives. The strategic approach described in this book will help you to turn good medical and scientific writing into successful writing. It describes clearly and concisely how to identify the target audience and the desired outcome, and how to construct key messages for a wide spectrum of documents. Irrespective of your level of expertise and your seniority in the pharmaceutical, regulatory, or academic environment, this book is an essential addition to your supporting library. The authors share with you many years of combined experience in the pharmaceutical and academic environment and in the writing of successful outcome-driven documents.
Author: Gladys Q. Ramey
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 112
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Book Description
Author: Jerry Brito
Publisher: Mercatus Center at George Mason University
ISBN: 0983607737
Category : Law
Languages : en
Pages : 128
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Book Description
Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.
Author: Mark P. Mathieu
Publisher: Omec
ISBN:
Category : Medical
Languages : en
Pages : 216
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Book Description
Author: Cary Coglianese
Publisher: University of Pennsylvania Press
ISBN: 0812207491
Category : Political Science
Languages : en
Pages : 290
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Book Description
Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.
Author: David Mantus
Publisher: CRC Press
ISBN: 1841849200
Category : Medical
Languages : en
Pages : 401
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Book Description
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Author: John Krige
Publisher: University of Chicago Press
ISBN: 022660599X
Category : Science
Languages : en
Pages : 453
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Book Description
Knowledge matters, and states have a stake in managing its movement to protect a variety of local and national interests. The view that knowledge circulates by itself in a flat world, unimpeded by national boundaries, is a myth. The transnational movement of knowledge is a social accomplishment, requiring negotiation, accommodation, and adaptation to the specificities of local contexts. This volume of essays by historians of science and technology breaks the national framework in which histories are often written. Instead, How Knowledge Moves takes knowledge as its central object, with the goal of unraveling the relationships among people, ideas, and things that arise when they cross national borders. This specialized knowledge is located at multiple sites and moves across borders via a dazzling array of channels, embedded in heads and hands, in artifacts, and in texts. In the United States, it shapes policies for visas, export controls, and nuclear weapons proliferation; in Algeria, it enhances the production of oranges by colonial settlers; in Vietnam, it facilitates the exploitation of a river delta. In India it transforms modes of agricultural production. It implants American values in Latin America. By concentrating on the conditions that allow for knowledge movement, these essays explore travel and exchange in face-to-face encounters and show how border-crossings mobilize extensive bureaucratic technologies.
