Clinical Affairs

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.15/5 ( download)

DOWNLOAD NOW!

Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 1003834019
Total Pages : 267 pages
Book Rating : 4.14/5 ( download)

DOWNLOAD NOW!

Download or read book Medical Affairs written by Kirk V. Shepard and published by CRC Press. This book was released on 2024-01-30 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 guideance 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 practic 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 13 :
Total Pages : 640 pages
Book Rating : 4.78/5 ( download)

DOWNLOAD NOW!

Download or read book Department of Veterans Affairs Publications Index written by United States. Department of Veterans Affairs. Publications Service and published by . This book was released on with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Dr Peter Kruse
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781519629012
Total Pages : 106 pages
Book Rating : 4.1X/5 ( download)

DOWNLOAD NOW!

Download or read book Medical Affairs in the Healthcare Industry written by Dr Peter Kruse and published by Createspace Independent Publishing Platform. This book was released on 2015-12-03 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527644717
Total Pages : 304 pages
Book Rating : 4.11/5 ( download)

DOWNLOAD NOW!

Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Commission on the Future Structure of Veterans Health Care
Publisher :
ISBN 13 :
Total Pages : 1190 pages
Book Rating : 4.21/5 ( download)

DOWNLOAD NOW!

Download or read book Proceedings of the Commission on the Future Structure of Veterans Health Care written by United States. Commission on the Future Structure of Veterans Health Care and published by . This book was released on 1991 with total page 1190 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : University of Michigan
Publisher :
ISBN 13 :
Total Pages : 600 pages
Book Rating : 4.06/5 ( download)

DOWNLOAD NOW!

Download or read book The President's Report to the Board of Regents for the Academic Year ... Financial Statement for the Fiscal Year written by University of Michigan and published by . This book was released on 1971 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : United States. Department of Veterans Affairs
Publisher :
ISBN 13 :
Total Pages : 44 pages
Book Rating : 4.85/5 ( download)

DOWNLOAD NOW!

Download or read book VA Catalog of Recurring Publication Code Numbers written by United States. Department of Veterans Affairs and published by . This book was released on 1994 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Kent Lewandrowski
Publisher : Springer
ISBN 13 : 3319341995
Total Pages : 303 pages
Book Rating : 4.96/5 ( download)

DOWNLOAD NOW!

Download or read book Utilization Management in the Clinical Laboratory and Other Ancillary Services written by Kent Lewandrowski and published by Springer. This book was released on 2016-11-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first comprehensive text on utilization management in the clinical laboratory and other ancillary services. It provides a detailed overview on how to establish a successful utilization management program, focusing on such issues as leadership, governance, informatics, and application of utilization management tools. The volume also describes ways to establish utilization management programs for multiple specialties, including anatomic pathology and cytology, hematology, radiology, clinical chemistry, and genetic testing among other specialties. Numerous examples of specific utilization management initiatives are also described that can be imported to other heath care organizations. A chapter on utilization management in Canada is also included. Edited by an established national leader in utilization management, Utilization Management in the Clinical Laboratory and Other Ancillary Services is a valuable resource for physicians, pathologists, laboratory directors, hospital administrators, and medical insurance professionals looking to implement a utilization management program.

Author : United States. Veterans Administration
Publisher :
ISBN 13 :
Total Pages : 398 pages
Book Rating : 4.84/5 ( download)

DOWNLOAD NOW!

Download or read book Veterans Administration Publications Index written by United States. Veterans Administration and published by . This book was released on 1989 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: