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EBookClubs

Read Books & Download eBooks Full Online

Book Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional

Download or read book Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional written by Raymond A. Huml and published by Springer Science & Business Media. This book was released on 2012-06-15 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a product’s lifespan on the market due to patent protection itself (or loss of patent protection) or via regulatory exclusivity. Case examples are discussed to illustrate the importance of keeping up with the ever-changing regulations, and how to interpret them in the context of CI. In addition, there is a section on virtual data rooms (VDRs) which currently function as the cornerstone of due diligence investigations. While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and regulatory affairs professionals in other regions. ​

Book Biotechnology Operations

Download or read book Biotechnology Operations written by John M. Centanni and published by CRC Press. This book was released on 2016-09-19 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.

Book The Textbook of Pharmaceutical Medicine

Download or read book The Textbook of Pharmaceutical Medicine written by John P. Griffin and published by John Wiley & Sons. This book was released on 2013-03-29 with total page 856 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine. This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine. Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine. The text breaks down into three core sections: Part I: Research and Development Part II: Regulation Part III: Healthcare marketplace View Table of Contents in detail

Book New Drug Development

Download or read book New Drug Development written by Mark P. Mathieu and published by Omec. This book was released on 1987 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book China Medical and Pharmaceutical Industry Business Intelligence Report Volume 1 Strategic Information  Regulations  Contacts

Download or read book China Medical and Pharmaceutical Industry Business Intelligence Report Volume 1 Strategic Information Regulations Contacts written by IBP, Inc and published by Lulu.com. This book was released on 2018-09-03 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: 2011 Updated Reprint. Updated Annually. China Pharmaceutical Chemicals Producers Directory

Book The SAGE Encyclopedia of Pharmacology and Society

Download or read book The SAGE Encyclopedia of Pharmacology and Society written by Sarah E. Boslaugh and published by SAGE Publications. This book was released on 2015-09-15 with total page 1883 pages. Available in PDF, EPUB and Kindle. Book excerpt: The SAGE Encyclopedia of Pharmacology and Society explores the social and policy sides of the pharmaceutical industry and its pervasive influence in society. While many technical STM works explore the chemistry and biology of pharmacology and an equally large number of clinically oriented works focus on use of illegal drugs, substance abuse, and treatment, there is virtually nothing on the immensely huge business (“Big Pharma”) of creating, selling, consuming, and regulating legal drugs. With this new Encyclopedia, the topic of socioeconomic, business and consumer, and legal and ethical issues of the pharmaceutical industry in contemporary society around the world are addressed. Key Features: 800 signed articles, authored by prominent scholars, are arranged A-to-Z and published in a choice of electronic or print formats Although arranged A-to-Z, a Reader's Guide in the front matter groups articles by thematic areas Front matter also includes a Chronology highlighting significant developments in this field All articles conclude with Further Readings and Cross References to related articles Back matter includes an annotated Resource Guide to further research, a Glossary, Appendices (e.g., statistics on the amount and types of drugs prescribed, etc.), and a detailed Index The Index, Reader’s Guide, and Cross References combine for search-and-browse capabilities in the electronic edition The SAGE Encyclopedia of Pharmacology and Society is an authoritative and rigorous source addressing the pharmacology industry and how it influences society, making it a must-have reference for all academic libraries as a source for both students and researchers to utilize.

Book Regulatory Affairs in the Pharmaceutical Industry

Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Book Drug Information

Download or read book Drug Information written by Bonnie Snow and published by Scarecrow Press. This book was released on 1999 with total page 772 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed for use as a self-study text, as a course text in more formal instruction programs, or as a refresher for the busy professional, the book includes valuable background data on legal and regulatory issues, as well as pharmaceutical technology.

Book Principles and Practice of Pharmaceutical Medicine

Download or read book Principles and Practice of Pharmaceutical Medicine written by Andrew J. Fletcher and published by John Wiley & Sons. This book was released on 2003-01-31 with total page 558 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook. * The authors are all experts in their field and include an assessment of the current status of their specialities * This book provides an insight into how things may develop in the future * It is designed to be a guide for those who are actually practicing pharmaceutical medicine

Book Optimization of Pharmaceutical R D Programs and Portfolios

Download or read book Optimization of Pharmaceutical R D Programs and Portfolios written by Zoran Antonijevic and published by Springer. This book was released on 2014-10-10 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.

Book Managing the Documentation Maze

Download or read book Managing the Documentation Maze written by Janet Gough and published by John Wiley & Sons. This book was released on 2010-03-16 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment’s notice. Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keeping Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage How to write and edit documents that meet regulatory compliance Making the transition to an electronic system, including how to validate and document the process Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny.

Book The SAGE Handbook of International Corporate and Public Affairs

Download or read book The SAGE Handbook of International Corporate and Public Affairs written by Phil Harris and published by SAGE. This book was released on 2016-12-06 with total page 729 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition of The SAGE Handbook of International Corporate and Public Affairs builds on the success of the first edition (2005) by comprehensively updating and enhancing the material and structure, setting a new standard for the practitioner and student of the global public affairs discipline. The new edition includes increased international coverage of the field, and a strong focus on emerging trends, as well as providing a comprehensive overview of the foundations and key aspects of the discipline. The Handbook is organised into six thematic sections, including a generously-sized section devoted to case studies of public affairs in action: Foundations of PA PA and its relationship to other Key Disciplines Emerging Trends in PA The Regional Development and Application of PA Case Studies of PA in Action Tactical Approaches to Executing PA. Containing contributions from leading experts in the field today, this Handbook is designed to serve the needs of scholars, researchers, students and professionals alike.

Book Chronolog

Download or read book Chronolog written by and published by . This book was released on 2002 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Vault Career Guide to Pharmaceuticals Sales and Marketing

Download or read book Vault Career Guide to Pharmaceuticals Sales and Marketing written by Carole Moussalli and published by Vault Inc.. This book was released on 2006-04 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get the inside scoop on pharmaceutical sales careers with this new Vault Guide. Overview of the industry; functions in pharmaceutical sales: field sales, sales management, training and development, instructional design/content development, project management; jobs and career paths; getting hired - education, interview preparation, and more.

Book Regulatory Intelligence 101

Download or read book Regulatory Intelligence 101 written by Meredith Brown-Tuttle and published by . This book was released on 2016 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book The Theory and Practice of Industrial Pharmacy

Download or read book The Theory and Practice of Industrial Pharmacy written by Prof (Dr.) Amit Upadhyay and published by AG PUBLISHING HOUSE (AGPH Books). This book was released on 2023-03-21 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of industrial pharmacy is to produce, develop, and sell medications that are safe and effective, and to ensure the quality of these processes across the whole production and distribution cycle. Studies in the industrial pharmacy are conducted both independently and under the supervision of Faculty of Pharmacy. The goal of industrial pharmacist is to ensure that new pharmaceutical products include the necessary components and do not contain excessive doses of those chemicals. There are several sub-industries within the pharmaceutical sector, each of which plays an essential position in the chain that begins with drug development and ends with the medication being sold to consumers. Pharmacists have the good fortune of being able to make significant professional contributions at almost every stage of the process. The regulatory affairs department of the pharmaceutical company is responsible for ensuring that the firm's drug products adhere to the guidelines set forth by the Medicines and Healthcare Products Regulatory Agency (MHRA), the Food and Drug Administration (FDA), and any other relevant regulatory bodies. Regulatory affairs groups also make sure that the product's intellectual property is appropriately secured by patent laws and can compete in the targeted market. Many pharmacists working in industry have branched out to other areas of the pharmaceutical business because of the opportunities it provides them to get expertise in a variety of settings.

Book Using the Pharmaceutical Literature

Download or read book Using the Pharmaceutical Literature written by Sharon Srodin and published by CRC Press. This book was released on 2006-02-16 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gathering information of critical importance for professionals in the pharmaceutical and medical device industries, this guide provides a comprehensive overview of key resources, such as databases, on-line directories, reports, and periodicals-providing at-a-glance guidance and collection development tools for information professionals in this fiel