Author: Jack Wong
Publisher: CRC Press
ISBN: 1000440516
Category : Medical
Languages : en
Pages : 806
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Book Description
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Author: Kirk V. Shepard
Publisher: CRC Press
ISBN: 1003834019
Category : Medical
Languages : en
Pages : 267
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Book Description
Medical Affairs is one of the three strategic pillars of the pharmaceutical and MedTech industries, but while clear career paths exist for Commercial and Research and Development, there is no formal training structure for Medical Affairs professionals. Medical and scientific expertise is a prerequisite for entry into the function, and many people transitioning into Medical Affairs have advanced degrees such as PhD, MD, or PharmD. However, these clinical/scientific experts may not be especially well-versed in aspects of industry such as the drug development lifecycle, crossfunctional collaborations within industry, and digital tools that are transforming the ways Medical Affairs generates and disseminates knowledge. This primer for aspiring and early-career Medical Affairs professionals equips readers with the baseline skills and understanding to excel across roles. Features: Defines the purpose and value of Medical Affairs and provides clear career paths for scientific experts seeking their place within the pharmaceutical and MedTech industries. Provides guidance and baseline competencies for roles within Medical Affairs including Medical Communications, Evidence Generation, Field Medical, Compliance, and many others. Specifies the "true north" of the Medical Affairs profession as ensuring patients receive maximum benefit from industry innovations including drugs, diagnostics and devices. Presents the purpose and specific roles of Medical Affairs roles across organization types including biotechs, small/medium/large pharma and device/diagnostic companies, taking into account adjustments in the practice of Medical Affairs to meet the needs of developing fields such as rare disease and gene therapy. Leverages the expertise of over 60 Medical Affairs leaders across companies, representing the first unified, global understanding of the Medical Affairs profession.
Author: United States. Department of Veterans Affairs. Publications Service
Publisher:
ISBN:
Category : Veterans
Languages : en
Pages : 640
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Book Description
Author: Dr Peter Kruse
Publisher: Createspace Independent Publishing Platform
ISBN: 9781519629012
Category : Business & Economics
Languages : en
Pages : 106
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Book Description
Peter Kruse MD, PhD, has divided a nearly 30 year professional career as a physician, scientist and working for the healthcare industry for global drug, biologics and medical device companies. This introduction to Medical Affairs gives a quick overview of this unique role that provides "the bridge" between Science and Business. Dr. Kruse shares his experience and some tricks of the trade - easy and to the point - for anyone working already in the Medical Affairs field or wishes to join it.
Author: Peter Kruse, M.D.
Publisher: Createspace Independent Publishing Platform
ISBN: 9781544254180
Category :
Languages : en
Pages : 102
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Book Description
Medical Affairs is of growing importance to the Healthcare Industry. To be able to provide optimal support to your Medical Affairs role you will need to "master" different tools. Your goal is to strive for excellence in Medical Affairs. This book gives an overview of one of the fundamental and important tools in The Medical Affairs Toolbox: Publication Planning. The art of ensuring that scientific and clinical data are generated in the development of a healthcare product to the right time and audience while adhering to best standards and guidelines. The author shares his experience and some tricks of the trade on effective Publication Planning both for larger and smaller companies. This book has its own living facebook page: https: //www.facebook.com/Publicationplanning/This is book 3 of the series "Healthcare Industry Excellence". Other books in this series are: Want a career in the Healthcare Industry? https: //www.amazon.com/gp/product/1530160421/ref=dbs_a_def_rwt_bibl_vppi_i2Medical Affairs an introductionhttps: //www.amazon.com/gp/product/151962901X/ref=dbs_a_def_rwt_bibl_vppi_i0
Author: United States. Commission on the Future Structure of Veterans Health Care
Publisher:
ISBN:
Category : Health planning
Languages : en
Pages : 1190
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Book Description
Author: University of Michigan
Publisher:
ISBN:
Category :
Languages : en
Pages : 600
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Book Description
Author: John J. Tobin
Publisher: John Wiley & Sons
ISBN: 3527644717
Category : Science
Languages : en
Pages : 304
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Book Description
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Author: United States. Department of Veterans Affairs
Publisher:
ISBN:
Category :
Languages : en
Pages : 44
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Book Description
Author: United States. Veterans Administration
Publisher:
ISBN:
Category : Government Publications
Languages : en
Pages : 398
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Book Description
