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: 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)

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.

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.

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

Designed for the practice of professional pharmacovigilance. MedDRA, FDA, EMEA, Eudravigilance, Regulatory framework submissions and timelines, GVP - 2012, Narrative Writing - Rules & Format, ARGUS, Signal Detection. Special Features. The Pharmacovigilance Interview: Can help you clear job interviews and start a career or get that better job. An exhaustive yet usable list of IME: Can help a professional differentiate between serious and non-serious cases and improve regulatory submission compliance.

Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacuetucal, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.