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Author: Gloria Hall
Publisher:
ISBN: 9781947493551
Category :
Languages : en
Pages :
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493551
Category :
Languages : en
Pages :
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Book Description
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: Lisa Schultz Bressman
Publisher: Aspen Publishing
ISBN: 1543815979
Category : Law
Languages : en
Pages : 1325
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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: Tom Brody
Publisher: Academic Press
ISBN: 0128042583
Category : Medical
Languages : en
Pages : 897
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Book Description
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Author: Mark P. Mathieu
Publisher: Omec
ISBN:
Category : Medical
Languages : en
Pages : 216
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493414
Category :
Languages : en
Pages :
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Book Description
Author: Cristina Hanganu-Bresch
Publisher: Routledge
ISBN: 100052809X
Category : Science
Languages : en
Pages : 515
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Book Description
Given current science-related crises facing the world such as climate change, the targeting and manipulation of DNA, GMO foods, and vaccine denial, the way in which we communicate science matters is vital for current and future generations of scientists and publics. The Routledge Handbook of Scientific Communication scrutinizes what we value, prioritize, and grapple with in science as highlighted by the rhetorical choices of scientists, students, educators, science gatekeepers, and lay commentators. Drawing on contributions from leading thinkers in the field, this volume explores some of the most pressing questions in this growing field of study, including: How do issues such as ethics, gender, race, shifts in the publishing landscape, and English as the lingua franca of science influence scientific communication practices? How have scientific genres evolved and adapted to current research and societal needs? How have scientific visuals developed in response to technological advances and communication needs? How is scientific communication taught to a variety of audiences? Offering a critical look at the complex relationships that characterize current scientific communication practices in academia, industry, government, and elsewhere, this Handbook will be essential reading for students, scholars, and professionals involved in the study, practice, and teaching of scientific, medical, and technical communication.
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: Danny Benau
Publisher:
ISBN: 9780997769753
Category : Documentation
Languages : en
Pages : 234
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Book Description
Author: Harold C. Sox
Publisher: John Wiley & Sons
ISBN: 1118341562
Category : Medical
Languages : en
Pages : 330
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Book Description
Medical Decision Making provides clinicians with a powerful framework for helping patients make decisions that increase the likelihood that they will have the outcomes that are most consistent with their preferences. This new edition provides a thorough understanding of the key decision making infrastructure of clinical practice and explains the principles of medical decision making both for individual patients and the wider health care arena. It shows how to make the best clinical decisions based on the available evidence and how to use clinical guidelines and decision support systems in electronic medical records to shape practice guidelines and policies. Medical Decision Making is a valuable resource for all experienced and learning clinicians who wish to fully understand and apply decision modelling, enhance their practice and improve patient outcomes. “There is little doubt that in the future many clinical analyses will be based on the methods described in Medical Decision Making, and the book provides a basis for a critical appraisal of such policies.” - Jerome P. Kassirer M.D., Distinguished Professor, Tufts University School of Medicine, US and Visiting Professor, Stanford Medical School, US
