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Author : Anonim
Publisher : Regulatory Affairs Professional Society
Page : 330 pages
File Size : 54,8 Mb
Release : 2011
Category : Drugs
ISBN : 0982932138
Author : Jamie Austin,Scott Brubaker,Jennifer Cabralda,Rita Casola,Wayne Critchley,Denise David,Michael Dietrich,Caroline Eve,Liz Anne Gillham-Eisen,Karen Grandoni-Rocco,Melanie Groleau,Brenda Gryfe,Raj Gulati,Anita Hammer,Susan Hibbeln,Vesna Janic,Allison Kennedy,Karen Long,John Lucas,Clare McCurley,E. Jane Mitchell,Hetal Mokashi,Nisha Pandya,Pamela Papineau,Michele Richardson,Anthony Ridgway,Kathryn Ronalds,Mary Speagle,Dinar Suleman,Austin Udocor,Richard Vincins,Penny Wilks,Amanda Wong,Audra Woodbeck,Brigitte Zirger
Publisher : Unknown
Page : 128 pages
File Size : 49,7 Mb
Release : 2014-01-05
Category : Electronic
ISBN : 0989802825
Reference book on the laws and regulations governing healthcare products on the Canadian market.
Author : Gloria Hall
Publisher : Unknown
Page : 128 pages
File Size : 40,5 Mb
Release : 2018-07-08
Category : Electronic
ISBN : 1947493132
Author : Gloria Hall,Pamela Anne Jones
Publisher : Unknown
Page : 726 pages
File Size : 55,7 Mb
Release : 2020-07-29
Category : Medical instruments and apparatus
ISBN : 1947493493
Fundamentals of Medical Device Regulations is a compilation of history, medical device and in vitro diagnotic (IVD) medical device information from RAPS' regional publications: Fundamentals of US Regulatory Affairs, Eleventh Edition; Fundamentals of Canadian Medical Device Regulations; Fundamentals of EU Regulatory Affairs, Ninth Edition; Fundamentals of International Regulatory Affairs, Fourth Edition."--Foreword.
Author : Canada. Treasury Board. Regulatory Affairs
Publisher : Unknown
Page : 128 pages
File Size : 42,9 Mb
Release : 1996
Category : Administrative procedure
ISBN : OCLC:54692291
Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 48,5 Mb
Release : 2014-05-23
Category : Electronic
ISBN : 0989802884
Compilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.
Author : Pamela Anne Jones
Publisher : Unknown
Page : 502 pages
File Size : 44,9 Mb
Release : 2018
Category : Electronic
ISBN : 1947493175
Author : David Mantus,Douglas J. Pisano
Publisher : CRC Press
Page : 401 pages
File Size : 51,6 Mb
Release : 2014-02-28
Category : Medical
ISBN : 9781841849201
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 : Javed Ali,Sanjula Baboota
Publisher : Academic Press
Page : 287 pages
File Size : 40,7 Mb
Release : 2021-11-14
Category : Medical
ISBN : 9780128222232
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Author : Malcolm Sparrow
Publisher : Unknown
Page : 144 pages
File Size : 54,5 Mb
Release : 2020-07-30
Category : Electronic
ISBN : 9798670959285
Subject: The modern regulatory world is crowded with ideas about different regulatory approaches including, among others: performance-based regulation, self-regulation, light-touch regulation, right-touch regulation, safety management systems, 3rd party regulation, co-regulation, prescriptive regulation, risk-based regulation, a harm-reduction approach, problem-solving, and responsive regulation. Are these various terms merely rhetorical, or aspirational? Do they signal the political preferences of the times? Which of them actually affect operations? Professional regulators--along with everyone else in the risk-control business--face a complex array of choices when they design (or redesign) their strategies and structures, programs, work-flows, relationships, and day-to-day operations. What regulators choose to do, and how they choose to do it, greatly affects their effectiveness, as well as the quality of life in a democracy. This book tackles five major design issues that affect all regulators (and can be applied by anyone else in the risk-control business). It demystifies the various labels and vogue prescriptions for regulatory conduct, clarifies the options, and generates a range of distinct ideas about what it might mean to be a "risk-based regulator." Audience: This book is designed primarily for regulatory practitioners, but will be relevant for other professionals whose roles include risk-management and harm-reduction. In the public sector, this includes law-enforcement and public-safety organizations, as well as security and intelligence agencies. In the private sector it includes compliance managers, safety officers and risk-managers. In the not-for-profit sector this includes any organization that takes on, or contributes to, harm-reduction missions. Author: Professor Malcolm K. Sparrow, of Harvard's Kennedy School of Government, has been working with senior officials in regulatory and enforcement agencies for over 30 years. Prior to joining Harvard's faculty in 1988, he served ten years with the British Police Service, rising to the rank of Detective Chief Inspector. He has authored eight other books, including The Regulatory Craft (Brookings, 2000) and The Character of Harms (Cambridge University Press, 2008). He chairs Harvard's Executive Program: "Strategic Management of Regulatory & Enforcement Agencies." Contents: This book is designed, in the context of a pandemic, to substitute for five core lectures/discussions that would normally be delivered face-to-face in executive-level courses and workshops. Professor Sparrow offers these lectures here in a comfortably accessible and conversational style. Each chapter describes a different dimension of choice, inviting readers to assess their own organization's history and habits as a precursor to figuring out whether, looking forward, some adjustment is warranted or desirable. Each chapter contains a collection of "Frequently Asked Questions" reflecting practitioners' common queries about the concepts presented, and ends with a "Diagnostic Exercise" (a set of probing questions) that readers can use, perhaps with colleagues in a book-group, to apply the analysis in their own setting. Online Teaching: Individual chapters can be assigned as "asynchronous study assignments" for courses on regulatory practice. Students, feeling "all screened out," may appreciate the availability of the paperback edition.
Author : Jocelyn Jennings,Linda McBride
Publisher : Unknown
Page : 128 pages
File Size : 42,5 Mb
Release : 2021-11-26
Category : Electronic
ISBN : 1947493736
Author : Stephen F. Amato,Robert M. Ezzell Jr
Publisher : Elsevier
Page : 202 pages
File Size : 46,9 Mb
Release : 2014-10-27
Category : Medical
ISBN : 9780857099204
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Author : Maria Cristina Galli
Publisher : Springer Nature
Page : 243 pages
File Size : 50,8 Mb
Release : 2023-08-01
Category : Science
ISBN : 9783031345678
This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, as well as pertinent ‘must-know’ guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: a Global Perspective is part of the American Society of Gene & Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Author : Val Theisz
Publisher : CRC Press
Page : 590 pages
File Size : 50,5 Mb
Release : 2015-08-03
Category : Medical
ISBN : 9789814669115
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
Author : Gloria Hall
Publisher : Unknown
Page : 128 pages
File Size : 48,6 Mb
Release : 2020-07-29
Category : Biologicals
ISBN : 1947493515