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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: Kirk V. Shepard
Publisher: CRC Press
ISBN: 1003834019
Category : Medical
Languages : en
Pages : 267
Get Book Here
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: 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: 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: Stephen F. Amato
Publisher: Elsevier
ISBN: 0857099205
Category : Technology & Engineering
Languages : en
Pages : 203
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Book Description
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: 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: 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
Author: Kent Lewandrowski
Publisher: Springer
ISBN: 3319341995
Category : Medical
Languages : en
Pages : 299
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Book Description
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.
