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Author: Linda Fossati Wood Publisher: Springer Science & Business Media ISBN: 3764383623 Category : Medical Languages : en Pages : 238
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 : 238
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: Miriam F. Williams Publisher: Routledge ISBN: 1351844202 Category : Psychology Languages : en Pages : 157
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
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: Jerry Brito Publisher: Mercatus Center at George Mason University ISBN: 0983607737 Category : Law Languages : en Pages : 128
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: Lisa Schultz Bressman Publisher: Aspen Publishing ISBN: 1543815979 Category : Law Languages : en Pages : 1325
Book Description
The Regulatory State, Third Edition is distinguished by a practical focus on how federal administrative agencies make decisions, how political institutions influence decisions, and how courts review those decisions. With coverage tailored to 1L or upper-level courses on the regulatory state or legislation and regulation, Bressman, Rubin, and Stack use primary source materials drawn from agency rules, adjudicatory orders, and guidance documents to show how lawyers engage agencies. Additionally, this book uses an accessible central example (auto safety) throughout to make the materials cohesive and accessible, and presents legislation with attention to modern developments in the legislative process. The Regulatory State, Third Edition also presents statutory interpretation in useful terms, highlighting the “tools” that courts employ as well as the theories that judges and scholars have offered. New to the Third Edition: Expanded discussion of agency methods of statutory implementation and regulatory interpretation Additional primary source materials Up-to-date examination of political and judicial control of agency action New chapter with a case study of the regulatory process using the main example from the book Professors and students will benefit from: Tools-based approach that highlights the methods of analysis that agencies, courts, and lawyers utilize Use of an accessible central example as a familiar entry point into a complex legal area Primary source materials—agency documents, including notice-and-comment rules, adjudicatory orders, agency guidance, and more Empirical data, normative or theoretical questions, and practical examples
Author: Suzanne Hidi Publisher: BRILL ISBN: 1849508216 Category : Education Languages : en Pages : 346
Book Description
The aim of this volume is to bring together contributions from international research on writing and motivation. It not only addresses the basic question of how motivation to write can be fostered, but also provides analyses of conceptual and theoretical issues at the intersection of the topics of motivation and writing. What emerges from the various chapters is that the motivational aspects of writing represent a rich, productive and partially still unexplored research field. This volume is a step in the direction of a more systematic analysis of the problems as well as an effort to present and compare various models, perspectives and methods of motivation and writing. It addresses the implications of writing instruction based on the 2 main approaches to writing research: cognitive and socio-cultural. It provides systematic analysis of the various models, perspectives, and methods of motivation and writing. It brings together the international research available in this burgeoning field.
Author: Linda Fossati Wood
Author: Linda Fossati Wood
Author: Gloria Hall
Author: Miriam F. Williams
Author: Pieter H. Joubert
Author: Gladys Q. Ramey
Author: Jerry Brito
Author: Lisa Schultz Bressman
Author: Danny Benau
Author: Suzanne Hidi
Author: Mark P. Mathieu