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Book Synopsis Pharmacovigilance Medical Writing by : Justina Orleans-Lindsay
Download or read book Pharmacovigilance Medical Writing written by Justina Orleans-Lindsay and published by John Wiley & Sons. This book was released on 2012-06-22 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.
Book Synopsis The Complete Guide to Medical Writing by : Mark C. Stuart
Download or read book The Complete Guide to Medical Writing written by Mark C. Stuart and published by Pharmaceutical Press. This book was released on 2007 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'The Complete Guide to Medical Writing' is intended to consider all aspects of medical/scientific writing in one concise introductory text. It explains how to get published, how to write for a particular audience or in a particular media, what the publishing processes are and what the financial rewards might be.
Book Synopsis Medical Writing in Drug Development by : Robert J Bonk
Download or read book Medical Writing in Drug Development written by Robert J Bonk and published by Routledge. This book was released on 2014-01-02 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide through the maze of the pharmaceutical research and development process, Medical Writing in Drug Development fills a gap in the libraries of technical writers, college instructors, and corporate professionals associated with the pharmaceutical process. As it discusses critical information, such as strategies and techniques pivotal to crafting documents for drug development, it also overviews drug research, document types, the roles of professional writers, and information technology. In no time at all, you will be creating persuasive technical documents, building complex facts into coherent messages, and contributing to the effective marketing of new products with promotional pieces that meet legal and ethical standards. Medical Writing in Drug Development helps medical writers and scientific, regulatory, and marketing professionals develop a working knowledge of the technical documents crucial to successful drug research. New and seasoned professional writers alike will benefit from the book's detailed discussions of: using abstracts, slides, and posters to present up-to-the-minute research how patient-education materials, health-economic assessments, and electronic journals provide ongoing challenges in medical writing a dossier approach that expedites regulatory submissions for international drug development structural constraints and rhetorical approaches toward regulatory documents presenting intricate information in scientifically unbiased, yet technically convincing language the effects of electronic publishing, computer graphics, and related technology on the practice of medical writing within pharmaceutical research Practical as a foundation text for undergraduate, graduate, and certificate programs in pharmaceutical or medical technical writing, Medical Writing in Drug Development will help you develop practical strategies for handling journal manuscripts, conference materials, and promotional pieces. No other text will clarify the main aspects of the pharmaceutical research and development process while offering you insight on the key issues dominating the healthcare arena.
Book Synopsis Strategic Scientific and Medical Writing by : Pieter H. Joubert
Download or read book Strategic Scientific and Medical Writing written by Pieter H. Joubert and published by Springer. This book was released on 2015-11-27 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: A document may be based on accurate medical and scientific information, follow guidelines precisely, and be well written in clear and correct language, but may still fail to achieve its objectives. The strategic approach described in this book will help you to turn good medical and scientific writing into successful writing. It describes clearly and concisely how to identify the target audience and the desired outcome, and how to construct key messages for a wide spectrum of documents. Irrespective of your level of expertise and your seniority in the pharmaceutical, regulatory, or academic environment, this book is an essential addition to your supporting library. The authors share with you many years of combined experience in the pharmaceutical and academic environment and in the writing of successful outcome-driven documents.
Book Synopsis Clinical Research and Pharmacovigilance by : Ravi Humbarwadi
Download or read book Clinical Research and Pharmacovigilance written by Ravi Humbarwadi and published by Createspace Independent Publishing Platform. This book was released on 2016-01-04 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: CLINICAL RESEARCH & CLINICAL TRIALS1. NEW DRUG DEVELOPMENT2. HISTORICAL EVENTS3. GOOD CLINICAL PRACTICE - ICH GCP4. CLINICAL TRIAL DESIGN5. SERIOUS ADVERSE EVENT - SAE6. SITE7. PHARMACODYNAMICS8. PHARMACOKINETICS9. BIOAVAILABILITY10. BIOEQUIVALENCE11. QC AND QA IN CLINICAL TRIALS12. CLINICAL DATA MANAGEMENT13. PHARMACOVIGILANCE14. GIPV - ONLINEPHARMACOVIGILANCE1. INTRODUCTION2. NEED FOR PHARMACOVIGILANCE3. DEFINITIONS4. TYPES OF REPORTS5. REPORTING PROCESS6. SPONTANEOUS REPORTS7. TIME FRAMES FOR REGULATORY REPORTING8. CIOMS FORM9. MEDDRA10. MEDDRA - A PERSPECTIVE11. WHO DRUG DICTIONARYVE12. ACTION TAKEN, DC AND RC13. CAUSALITY ASSESSMENT14. UNBLINDING & SUSAR15. POST TREATMENT AND PRE-TREATMENT STUDY16. WORKFLOW17. THE PHARMACOVIGILANCE SYSTEM - EUDRAVIGILANCE.18. EMEA- GVP19. FDA: ADJUDICATION AND ADVISORY PANEL20. BACK TO THE FUTURE: VIOXX, MEDIATOR & THALIDOMIDE21. REGULATION AND DIRECTIVE ON PHARMACOVIGILANCE22. ASSESSMENT OF SERIOUSNESS FROM SOCIAL MEDIA23. SIGNAL DETECTION24. PROCESS OF SIGNAL DETECTION25. ARGUS 26. NARRATIVE WRITING - RULES & FORMAT27. IMPORTANT MEDICAL EVENT LIST28. GLOSSARY29. THE PHARMACOVIGILANCE INTERVIEW30. SERIOUS VS NON-SERIOUS: CASE STUDY & THUMB RULES
Book Synopsis Medicomarketing Writing by : Viswanatha Mathad
Download or read book Medicomarketing Writing written by Viswanatha Mathad and published by Bsp Books Pvt. Limited. This book was released on 2016-10-07 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical writing is part of drug development process. Medicomarketing writing is a type of medical writing where scientific information is presented as promotional literatures. Medicomarketing communication or healthcare communication has evolved as a profession over a decade. More and more pharmaceutical industries are outsourcing their work to medicomarketing communication or healthcare communication companies and freelance medical writers. The skills required for medicomarketing writing are different from the skills required for any other profession. With more than 15 years of experience in medicomarketing communication segment, we have identified the skills required for medicomarketing writing and the lack of skill among the pharmacists, doctors and life science graduates, who have the ability to excel in medical writing. This is the first book, which gives practical insights into medicomarketing writing. This book is ideal for graduates and postgraduates in -Pharmacy -Medicine -Dentistry and -Life science This book is also useful for -Newbie medicomarketing writers -Product managers and medical advisors working in pharmaceutical companies -Senior medical writers working in publishing companies -Team leaders and project managers working in medical communication and medical advertising agencies -Freelance medical writers
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 526 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
Book Synopsis Writing High-Quality Medical Publications by : Stephen W Gutkin
Download or read book Writing High-Quality Medical Publications written by Stephen W Gutkin and published by CRC Press. This book was released on 2018-07-17 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: The imperative to "publish and not perish" has never been more compelling. Yet millions of manuscripts are prepared each year without a clear path to publication by a peer-reviewed medical journal. Enter "The Gutkin Manual." Drawing from the author's distinguished, nearly 30-year career, this comprehensive and supportive guide helps to get your paper accepted—and by the journal of first choice. Elucidating pivotal principles of quality, and biostatistics, and informed by the belief that your writing can be engaging, elegant, and memorable—no matter how technical and complex the subject matter, this volume can be your trustworthy companion as you seek to enhance both the structure and substance of your manuscripts.
Book Synopsis The Role of the Pharmacist in Patient Care by : Abdul Kader Mohiuddin
Download or read book The Role of the Pharmacist in Patient Care written by Abdul Kader Mohiuddin and published by Universal-Publishers. This book was released on 2020 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making for the professional pharmacist, apprentice and student. In every chapter, the role of pharmacists in that chapter specific issues are detailed explicitly so that a professional pharmacist or a student can figure out his or her do’s and don’ts in that specific situation. Moreover, further reading references are listed as future recommendations. So, the book is an archive of potential references too. Among so many books about patient care, either doctors’ or nurses’ roles are highlighted. The proposed book highlights the pharmacists’ roles and responsibilities to the most, separated from those of doctors and nurses, with the most recent information obtained from most publications in several journals, books, bulletins, newsletter, magazines etc.
Book Synopsis Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics by : Linda Fossati Wood
Download or read book Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics written by Linda Fossati Wood and published by Springer Science & Business Media. This book was released on 2009-01-05 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Book Synopsis SAS Clinical Programming by : Y. LAKSHMI PRASAD
Download or read book SAS Clinical Programming written by Y. LAKSHMI PRASAD and published by Notion Press. This book was released on 2014-09-12 with total page 459 pages. Available in PDF, EPUB and Kindle. Book excerpt: An indispensable guide to SAS Clinical Programming, this book is the first guide on this topic, to be written by an Indian author. Written in an instructive and conversational tone for people who want to make their career in SAS Clinical Programming and entry level programmers for their day-to-day tasks. It is equipped with practical, real world examples, detailed description of programs, work flows, issues, resolutions and key techniques. This book is a personal SAS Clinical trainer. It explains the art of SAS Clinical Programming in eighteen easy steps, covering everything from basics to ADS, TLF Creation, as well as CDISC SDTM and ADaM specifications. Many statistical concepts are explained in an easy way so that you feel confident while using Statistical Procedures. If you are already working as a SAS Clinical Programmer, this book will aid you with sharpening your skills.
Book Synopsis Pharmacovigilance by : Ronald D. Mann
Download or read book Pharmacovigilance written by Ronald D. Mann and published by John Wiley & Sons. This book was released on 2007-02-06 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an international team of outstanding editors andcontributors, Pharmacovigilance, 2ndEdition is the definitive text on this importantsubject. The new edition has been completely revised andupdated to include the latest theoretical and practical aspects ofpharmacovigilance including legal issues, drug regulatoryrequirements, methods of signal generation, reporting schemes andpharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing withinthe pharmacovigilance community The text provides exemplary coverage of all the relevantissues The definitive book on the subject
Book Synopsis Global Clinical Trials Playbook by : Menghis Bairu
Download or read book Global Clinical Trials Playbook written by Menghis Bairu and published by Academic Press. This book was released on 2012-06-12 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios
Book Synopsis Effective Medical Writing: The Write Way To Get Published (UM Press) by : Wifred C.G Peh
Download or read book Effective Medical Writing: The Write Way To Get Published (UM Press) written by Wifred C.G Peh and published by The University of Malaya Press. This book was released on 2010 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Effective Medical Writing. The Write Way to get Published was edited and updated from a series of well-received articles published in the Singapore Medical Journal. These articles were used extensively as resource material for numerous medical and scientific writing workshops held in several countries such as Singapore, Malaysia, Thailand, and include the first ever national medical writing workshops staged in The Philippines, Brunei Darussalam, Vietnam, Cambodia and Mongolia, Most of these workshops were endorsed by the Asia Pacific Association of Medical Journal Editors. This book will be helpful to medical and postgraduate students, clinical specialty trainees, aspiring researchers, newly-appointed academic staff, allied health professionals, and those who are looking to write scientific papers and get published. This book is written in an easy-to-read style, covering all the steps required to prepare manuscripts for biomedical and healthcare publications. The reader will learn about “must-know” issues relating to manuscript processing, authoring, reviewing, editing and other key points related to publishing.
Book Synopsis Pharmacovigilance: A Practical Approach by : Thao Doan
Download or read book Pharmacovigilance: A Practical Approach written by Thao Doan and published by Elsevier Health Sciences. This book was released on 2018-07-31 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
Author :Publications Division Publisher :Publications Division Ministry of Information & Broadcasting ISBN 13 :8119936205 Total Pages :363 pages Book Rating :4.1/5 (199 download)
Book Synopsis Career Calling by : Publications Division
Download or read book Career Calling written by Publications Division and published by Publications Division Ministry of Information & Broadcasting. This book was released on 2023-02-17 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a compilation of articles published in Employment News with focus on new and upcoming career avenues.
Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews
Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-03-24 with total page 872 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
