Please note that the Print Replica PDF digital version does not contain the audio. English for the Pharmaceutical Industry is part of the EXPRESS SERIES. It is the ideal quick course for anyone who needs English to communicate with colleagues and contacts in the pharmaceutical sector. It can be used to supplement a regular coursebook, on its own, as a stand-alone intensive specialist course, or for self-study. Whichever part of the industry you work in – Research, Development, Manufacturing, or Marketing – English for the Pharmaceutical Industry will give you the English you need to communicate across this complex sector.
English for the Pharmaceutical Industry teaches students how to communicate effectively in different areas of pharmaceuticals. The course is suitable for a range of pharmaceutical professionals, such as chemists, formulation scientists, lab technicians, medical writers, and clinical researchers. English for the Pharmaceutical Industry has six units which cover the core areas of pharmaceuticals, from initial substance discovery to the final stages of production and packaging. Every unit uses authentic situations and dialogues to concentrate on one fundamental aspect of the industry. This short, intensive course can be completed in 25-30 hours, so students make progress quickly. Table of contents: * Unit 1: The kick-off meeting: Providing information, introducing oneself, one's field and projects, summarizing action points, writing job ads. * Unit 2: Substance discovery: Asking about drug discovery and drug development, talking about time periods, asking for and giving opinions. * Unit 3: Quality assurance and auditing: Informing, asking questions during an audit, suggesting corrective action, discussing SOPs. * Unit 4: Reading for testing in live organisms: Describing a process, getting information, making suggestions, linking ideas, requesting information and responding directly. * Unit 5: Drug safety and regulatory affairs: Reporting severe adverse events, discussing the causes of SAEs, asking about implications form a drug, giving general advice, giving strong warnings. * Unit 6: Production and packaging: Expressing moments in time, giving instructions, describing a process, giving presentations.
The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
This handbook is the definitive quick reference guide to clinical pharmacy, providing practising and student pharmacists with a wealth of practical information.
Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.
First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
From "pharma bros" to everday household budgets, just how did the pharmaceutical industry betray its own history—and how can it return to its tradition of care? It’s an unfortunate and life-threatening fact: one in five Americans has skipped vital prescriptions simply because of the cost. These choices are being made even though we have reached a point in the conveyance of medical options where cancers can be cured and sight restored for those blinded by rare genetic disorders. How, in this time of such advancements, did we reach a point, where people cannot afford the very things that could save their lives? As the COVID-19 global pandemic has pointed out, we need the leadership of scientists, researchers, public health officials and lawmakers alike to guide us through not only in times of a global health crisis, but also during far more mundane times. For the first time in decades, people from all walks of life face the same need for medicine. It is time to discuss the tough questions about drug pricing in an open, honest and, hopefully, transparent manner. But first we must understand how we, as a society, got here. Medicines are arguably the most highly regulated—and cost-inflated—products in the United States. The discovery, development, manufacturing and distribution of medicines is carried out by an ever more complex and crowded set of industries, each playing a part in a larger “pharmaceutical enterprise” seeking to maximize profits. But this was not always the case. The Price of Health is the reveals the story of how the pharmaceutical enterprise took shape and led to the present crisis. The reputation of the pharmaceutical industry is suffering from self-inflicted wounds and its continued viability, indeed survival, is increasingly questioned. Yet the drug makers do not shoulder all the blame or responsibility for the current price crisis. Deeply researched, The Price of Health gives us hope as to how we can still right the ship, even amidst the roiling storm of a global pandemic. How have medicines have been made and distributed to consumers throughout the years? What sea of changes that have contributed to rising costs? Some individuals, actions, and systems will be familiar, others may surprise. Yet the combined implications of these actions for will be surprising and at times shocking to both industry professionals and average Americans alike. Like so much else in human history, the history of the pharmaceutical enterprise is populated mostly by well-intended and even noble individuals and organizations. Each contributed to the formation or maintenance of structures meant to improve the quality and quantity of life through the development and distribution of medicines. And yet systems originally created to do good have often been subverted in ways contrary to the motivations of their creators. Only by understanding this disconnect can we better tackle the underlying problems of the industry head on, preventing foreseeable, and thus avoidable, medical calamities to come.
