Clinical Affairs

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Medical Affairs

Author : Kirk V. Shepard
Publisher : CRC Press
ISBN 13 : 1003834019
Total Pages : 267 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Medical Affairs by : Kirk V. Shepard

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 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.

Medical Regulatory Affairs

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Medical Regulatory Affairs by : Jack Wong

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.

Medical Affairs in the Healthcare Industry

Author : Dr Peter Kruse
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781519629012
Total Pages : 106 pages
Book Rating : 4.6/5 (29 download)

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Book Synopsis Medical Affairs in the Healthcare Industry by : Dr Peter Kruse

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.

Calming America

Author : Dennis S. O’Leary MD
Publisher : iUniverse
ISBN 13 : 166323292X
Total Pages : 882 pages
Book Rating : 4.6/5 (632 download)

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Book Synopsis Calming America by : Dennis S. O’Leary MD

Download or read book Calming America written by Dennis S. O’Leary MD and published by iUniverse. This book was released on 2022-09-16 with total page 882 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pot Luck Spokesman? The information void in the hours following the shooting of US President Ronald Reagan late Monday afternoon, March 30, 1981, spawned many false rumors and misinformation, which White House political adviser Lyn Nofziger understood threatened the credibility of the White House. He therefore took the podium before the 200 plus assembled press in Ross Hall to tell them that he would be bringing with him a credible physician to brief them once the president was out of surgery. However, he didn’t have many options to draw from for that credible physician. At the hospital, the surgeons tending the three shooting victims had first-hand information about the afternoon’s events, but each surgeon knew only about his own injured patient. White House physician Dan Ruge meanwhile had been at the president’s side throughout the afternoon and was a possible candidate, but his White House association made his credibility suspect according to White House aides. The job became the drafting of the most logical person to be spokesman. That would have been the seasoned physician CEO of the George Washington University Medical Center Ron Kaufman, but he was out of town. Next up was Dennis O’Leary, the physician dean for clinical affairs, as the preferred spokesman. To the White House, O’Leary was a total unknown, but a review of his credentials would hardly have been reassuring. He had originally been recruited to George Washington University as a blood specialist. Reticent by nature, he had minimal public-relations and public-speaking experience, save two years as a member of his hometown high school debate team. He had no surgical or trauma training or experience. But beggars can’t be choosers, as the saying goes. Kindly stated, O’Leary was probably the least bad choice to serve as White House/hospital spokesman to inform the world of the status of the wounded President Reagan, special agent Tim McCarthy, and press secretary Jim Brady. Yet, with a little bit of luck, it might all work out. And it did.

Medical Polymers

Author :
Publisher : iSmithers Rapra Publishing
ISBN 13 : 9781859573358
Total Pages : 202 pages
Book Rating : 4.5/5 (733 download)

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Book Synopsis Medical Polymers by :

Download or read book Medical Polymers written by and published by iSmithers Rapra Publishing. This book was released on 2003 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Polymers 2003, the third international conference devoted to the use of polymers in the medical industry was held in Dublin, Ireland. The use of polymers in medical technology continues to grow and provides major business opportunities for companies who service the medical industry. Medical Polymers 2003 brought together speakers and delegates from the whole medical device supply chain to identify and address the challenges facing the industry. The conference began with a keynote presentation from the head of European and Regulatory Affairs at the Medical Devices Agency highlighting the many important regulatory issues now facing the industry. Following sessions covered new materials, latest product developments, compatibility of polymers, material advances, analysis and testing of medical polymers.

Proceedings of the Commission on the Future Structure of Veterans Health Care

Author : United States. Commission on the Future Structure of Veterans Health Care
Publisher :
ISBN 13 :
Total Pages : 1186 pages
Book Rating : 4.:/5 (3 download)

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Book Synopsis Proceedings of the Commission on the Future Structure of Veterans Health Care by : United States. Commission on the Future Structure of Veterans Health Care

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 1186 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Medicine and Translational Clinical Research

Author : Divya Vohora
Publisher : Academic Press
ISBN 13 : 0128020989
Total Pages : 527 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Pharmaceutical Medicine and Translational Clinical Research by : Divya Vohora

Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Clinical and Translational Science

Author : David Robertson
Publisher : Academic Press
ISBN 13 : 012802111X
Total Pages : 812 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical and Translational Science by : David Robertson

Download or read book Clinical and Translational Science written by David Robertson and published by Academic Press. This book was released on 2016-11-25 with total page 812 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

The Clinical Research Process in the Pharmaceutical Industry

Author : Gary M. Matoren
Publisher : CRC Press
ISBN 13 : 1000148718
Total Pages : 584 pages
Book Rating : 4.0/5 (1 download)

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Book Synopsis The Clinical Research Process in the Pharmaceutical Industry by : Gary M. Matoren

Download or read book The Clinical Research Process in the Pharmaceutical Industry written by Gary M. Matoren and published by CRC Press. This book was released on 2020-08-18 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.

Monthly Catalog of United States Government Publications

Author :
Publisher :
ISBN 13 :
Total Pages : 1200 pages
Book Rating : 4.:/5 (891 download)

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Book Synopsis Monthly Catalog of United States Government Publications by :

Download or read book Monthly Catalog of United States Government Publications written by and published by . This book was released on with total page 1200 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Monthly Catalogue, United States Public Documents

Author :
Publisher :
ISBN 13 :
Total Pages : 1690 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Monthly Catalogue, United States Public Documents by :

Download or read book Monthly Catalogue, United States Public Documents written by and published by . This book was released on 1991 with total page 1690 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Veterans Administration Publications Index

Author : United States. Veterans Administration
Publisher :
ISBN 13 :
Total Pages : 398 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Veterans Administration Publications Index by : United States. Veterans Administration

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:

VA Catalog 1-P Publications Log 1, September, 2003

Author :
Publisher :
ISBN 13 :
Total Pages : 156 pages
Book Rating : 4.3/5 ( download)

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Book Synopsis VA Catalog 1-P Publications Log 1, September, 2003 by :

Download or read book VA Catalog 1-P Publications Log 1, September, 2003 written by and published by . This book was released on 2004 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Production of Plasma Proteins for Therapeutic Use

Author : Joseph Bertolini
Publisher : John Wiley & Sons
ISBN 13 : 0470924314
Total Pages : 518 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Production of Plasma Proteins for Therapeutic Use by : Joseph Bertolini

Download or read book Production of Plasma Proteins for Therapeutic Use written by Joseph Bertolini and published by John Wiley & Sons. This book was released on 2012-12-26 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth the state of the science and technology in plasma protein production With contributions from an international team of eighty leading experts and pioneers in the field, Production of Plasma Proteins for Therapeutic Use presents a comprehensive overview of the current state of knowledge about the function, use, and production of blood plasma proteins. In addition to details of the operational requirements for the production of plasma derivatives, the book describes the biology, development, research, manufacture, and clinical indications of essentially all plasma proteins with established clinical use or therapeutic potential. Production of Plasma Proteins for Therapeutic Use covers the key aspects of the plasma fractionation industry in five sections: Section 1: Introduction to Plasma Fractionation initially describes the history of transfusion and then covers the emergence of plasma collection and fractionation from its earliest days to the present time, with the commercial and not-for-profit sectors developing into a multi-billion dollar industry. Section 2: Plasma Proteins for Therapeutic Use contains 24 chapters dedicated to specific plasma proteins, including coagulation factors, albumin, immunoglobulin, and a comprehensive range of other plasma-derived proteins with therapeutic indications. Each chapter discusses the physiology, biochemistry, mechanism of action, and manufacture of each plasma protein including viral safety issues and clinical uses. Section 3: Pathogen Safety of Plasma Products examines issues and procedures for enhancing viral safety and reducing the risk of transmissible spongiform encephalopathy transmission. Section 4: The Pharmaceutical Environment Applied to Plasma Fractionation details the requirements and activities associated with plasma collection, quality assurance, compliance with regulatory requirements, provision of medical affairs support, and the manufacture of plasma products. Section 5: The Market for Plasma Products and the Economics of Fractionation reviews the commercial environment and economics of the plasma fractionation industry including future trends, highlighting regions such as Asia, which have the potential to exert a major influence on the plasma fractionation industry in the twenty-first century.

VA Catalog of Recurring Publication Code Numbers

Author : United States. Veterans Administration
Publisher :
ISBN 13 :
Total Pages : 44 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis VA Catalog of Recurring Publication Code Numbers by : United States. Veterans Administration

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

California. Court of Appeal (4th Appellate District). Division 2. Records and Briefs

Author : California (State).
Publisher :
ISBN 13 :
Total Pages : 136 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis California. Court of Appeal (4th Appellate District). Division 2. Records and Briefs by : California (State).

Download or read book California. Court of Appeal (4th Appellate District). Division 2. Records and Briefs written by California (State). and published by . This book was released on with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:

From PharmD to Industry

Author : Victoria Langas
Publisher : Springer Nature
ISBN 13 : 3031357876
Total Pages : 101 pages
Book Rating : 4.0/5 (313 download)

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Book Synopsis From PharmD to Industry by : Victoria Langas

Download or read book From PharmD to Industry written by Victoria Langas and published by Springer Nature. This book was released on 2023-07-25 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many Doctor of Pharmacy (PharmD) candidates, post-graduate training is a highly prestigious and sought after experience that can further one’s pre-existing education. Some of these post-graduate training opportunities include but are not limited to pharmacy residencies, pharmaceutical industry fellowships, and PhD/Masters programs. There is a large gap in the current Doctor of Pharmacy curriculum about pharmaceutical industry fellowship programs and potential pharmaceutical industry opportunities. Through the eyes of current industry fellows and professionals, this book serves as a resource to learn more about fellowship opportunities and their respective application processes. In addition, this manual aims to provide a clear and concise roadmap to achieving a career in industry through a fellowship program. Whether you are a current student pharmacist, post-graduate pharmacy trainee (pharmacy resident), or industry professional, this manual addresses the current landscape of industry fellowship programs, an overview of industry opportunities, and a glimpse into what being a fellow entails. Readers of this book can expect to gain: An overview of pharmaceutical industry fellowship programs and opportunities Helpful advice and insight from current fellows and industry professionals A streamlined pathway to navigating the fellowship application process An understanding of the journey from being a student, to achieving a fellowship, to becoming an industry professional This book bridges the gap in education surrounding pharmaceutical industry fellowships and pharmacy careers in industry and increases access to first-hand information and real-world perspectives of current professionals to provide a firm foundation for those interested in pursuing a career in industry or learning more about fellowship programs.