Medical Affairs

Medical Affairs
Author: Kirk V. Shepard
Publisher: CRC Press
Total Pages: 267
Release: 2024-01-30
Genre: Medical
ISBN: 1003834019

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

Medical Regulatory Affairs
Author: Jack Wong
Publisher: CRC Press
Total Pages: 806
Release: 2022-01-27
Genre: Medical
ISBN: 1000440516

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

Medical Affairs in the Healthcare Industry
Author: Dr Peter Kruse
Publisher: Createspace Independent Publishing Platform
Total Pages: 106
Release: 2015-12-03
Genre: Business & Economics
ISBN: 9781519629012

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

Calming America
Author: Dennis S. O’Leary MD
Publisher: iUniverse
Total Pages: 882
Release: 2022-09-16
Genre: Biography & Autobiography
ISBN: 166323292X

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

Medical Polymers
Author:
Publisher: iSmithers Rapra Publishing
Total Pages: 202
Release: 2003
Genre: Biomedical materials
ISBN: 9781859573358

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.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
Author: Divya Vohora
Publisher: Academic Press
Total Pages: 527
Release: 2017-11-14
Genre: Medical
ISBN: 0128020989

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

Clinical and Translational Science
Author: David Robertson
Publisher: Academic Press
Total Pages: 812
Release: 2016-11-25
Genre: Science
ISBN: 012802111X

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

The Clinical Research Process in the Pharmaceutical Industry
Author: Gary M. Matoren
Publisher: CRC Press
Total Pages: 584
Release: 2020-08-18
Genre: Business & Economics
ISBN: 1000148718

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.