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Pharmacovigilance Medical Writing

2012-06-22 Medical
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Release : 2012-06-22
Genre : Medical
Kind : eBook
Book Rating : 060/5 ( reviews)

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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. This book was released on 2012-06-22. 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.

Drug Safety Data

2011 Medical
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Release : 2011
Genre : Medical
Kind : eBook
Book Rating : 126/5 ( reviews)

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Book Synopsis Drug Safety Data by : Michael J. Klepper

Download or read book Drug Safety Data written by Michael J. Klepper. This book was released on 2011. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides pharmaceutical scientists, researchers and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for premarketing risk assessment. This unique resource enhances the ability of pharmaceutical professionalsùthose with and without clinical trainingùto determine the risk of a drug or biologic­ ahead of its release, thereby reducing unnecessary jeopardy to the patient. Authors Dr. Michael Klepper and Dr. Barton Cobert, who together bring decades of pharmaceutical research and drug safety expertise, discuss how quality planning, safety training and data standardization result in significant cost, time and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides the definitive guide to drug safety data analysis and reporting. Key features include: Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports Pragmatic tipsàand mistakes to avoid Simple explanations of what safety data are collected, and what the data mean Practical approaches to determining a drug effect and understanding its clinical significance Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical Examples of user-friendly data displays that enhance safety signal identification Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting Relevant material for the required training of drug safety/pharmacovigilance professionals SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Clinical Research and Pharmacovigilance

2016-01-04
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Release : 2016-01-04
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Kind : eBook
Book Rating : 682/5 ( reviews)

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Book Synopsis Clinical Research and Pharmacovigilance by : Ravi Humbarwadi

Download or read book Clinical Research and Pharmacovigilance written by Ravi Humbarwadi. This book was released on 2016-01-04. 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

Mann's Pharmacovigilance

2014-06-23 Medical
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Release : 2014-06-23
Genre : Medical
Kind : eBook
Book Rating : 041/5 ( reviews)

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Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews

Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews. This book was released on 2014-06-23. 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.

Writing High-Quality Medical Publications

2018-07-17 Medical
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Release : 2018-07-17
Genre : Medical
Kind : eBook
Book Rating : 963/5 ( reviews)

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Book Synopsis Writing High-Quality Medical Publications by : Stephen Gutkin

Download or read book Writing High-Quality Medical Publications written by Stephen Gutkin. This book was released on 2018-07-17. 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.

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