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.
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.
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:
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.
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.
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:
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:
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:
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.
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:
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:
Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Alternative Careers in Science written by Cynthia Robbins-Roth and published by Academic Press. This book was released on 1998 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: You can do more with your science degree than you ever dreamed. In this book, readers will meet scientists who evolved into Wall Street analysts, science policy gurus, patent agents, journalists, and top-flight sales reps. Each chapter covers a different career track and shows why having a graduate degree in science gives you an edge.
Download or read book The Challenges of Conducting Medical Device Studies written by Keith Summerhayes and published by Inst of Clinical Research. This book was released on 2005 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describing all the regulations, guidelines and directives that affect medical device studies.
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.
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.
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:
