Download or read book Fundamentals of EU Regulatory Affairs Eighth Edition written by Gloria Hall and published by . This book was released on 2017-12-15 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Fundamentals of EU Regulatory Affairs 9th Edition written by Gloria Hall and published by . This book was released on 2020-06-26 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book HealthTech written by Jelena Madir and published by Edward Elgar Publishing. This book was released on 2020-10-30 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.

Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Fundamentals of EU Regulatory Affairs written by Raps and published by . This book was released on 2002-06-30 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Fundamentals of EU Regulatory Affairs written by and published by . This book was released on 2015 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Fundamentals of US Regulatory Affairs Eighth Edition written by Alix E. Alderman and published by . This book was released on 2013-06-30 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Fundamentals of EU Regulatory Affairs Sixth Edition written by Mujadala Abdul-Majid and published by . This book was released on 2012-06-28 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Fundamentals of EU Regulatory Affairs Fourth Edition written by Regulatory Affairs Professionals Society and published by . This book was released on 2008-06-01 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Skin Aging Handbook written by Nava Dayan and published by William Andrew. This book was released on 2008-10-17 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: Anti-aging products are undergoing exceptional growth in the cosmetics industry far beyond that of general cosmetics. This book is the only available text that assembles the key pieces developers need to produce new breakthroughs for a growing market that demands quicker and more effective results. It also focuses much needed attention on the biochemical and clinical differences between Caucasian and other skin types.Beginning with detailed descriptions of the forces driving the anti-aging market, this unique book provides readers with all the tools necessary to further research, develop, market, and sell novel products. Recent discoveries on the molecular level and novel methods of skin aging assessment are detailed as well as the state of the rapidly changing global regulatory environment. The formulation approaches of major cosmetics companies are presented as are their techniques for measuring skin aging in vitro and in vivo, both on the molecular and clinical levels. - Provides philosophical perspective on the growth of the anti-aging market - Covers skin types beyond Caucasian - Provides key pieces for developing and selling new breakthrough products - Includes technology from major cosmetic companies such as Chanel, Avon, Estee lauder and others

Download or read book Fundamentals of Us Regulatory Affairs 2005 written by Mika Reinikainen and published by . This book was released on 2005-01-01 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Directives and regulations governing healthcare products in the EU.

Download or read book Fundamentals of EU Regulatory Affairs written by and published by . This book was released on 2004 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Download or read book Cell and Gene Therapies written by Miguel-Angel Perales and published by Springer. This book was released on 2018-11-27 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this book, experts in the field express their well-reasoned opinions on a range of complex, clinically relevant issues across the full spectrum of cell and gene therapies with the aim of providing trainee and practicing hematologists, including hematopoietic transplant physicians, with information that is relevant to clinical practice and ongoing research. Each chapter focuses on a particular topic, and the concise text is supported by numerous working tables, algorithms, and figures. Whenever appropriate, guidance is provided regarding the availability of potentially high-impact clinical trials. The rapid evolution of cell and gene therapies is giving rise to numerous controversies that need to be carefully addressed. In meeting this challenge, this book will appeal to all residents, fellows, and faculty members responsible for the care of hematopoietic cell transplant patients. It will also offer a robust, engaging tool to aid vital activities in the daily work of every hematology and oncology trainee.

Download or read book Fundamentals of Us Regulatory Affairs 2007 written by Nardone and published by . This book was released on 2007-08-01 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Fundamentals of US Regulatory Affairs written by and published by . This book was released on 2013 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Regulatory Theory written by Peter Drahos and published by ANU Press. This book was released on 2017-02-23 with total page 820 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.