The Global Guide to Pharma Marketing Codes will help marketers maximise public relations opportunities around the world. This publication provides an overview of basic healthcare promotional regulations, and answers the most frequently asked questions about what is and isn't permitted with respect to the media and third party involvement. This truly unique guide was produced with the insight and expertise of the largest independent public relations group dedicated exclusively to health and medical communications worldwide. GLOBALHealthPR (GHPR) is an international partnership uniting some of the world's most successful independent healthcare public relations firms and their affiliates from major markets in Europe, the Americas and Asia.
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
Explore the nuts and bolts of marketing pharmaceuticals today! Written by leading authorities in the field, Pharmaceutical Marketing: Principles, Environment, and Practice is the fifth in Dr. Mickey Smith's series of books on the subject which began in the 1960s. In this extraordinary book, he and his co-authors examine the principles of marketing pharmaceuticals, describe the environmental factors that affect their application, and show how these principles can be applied in response to those factors in practice. From the history and development of marketing pharmaceuticals to channel systems, legal requirements, budgeting, and product placement, this essential volume is a comprehensive text that will help students prepare for successful careers in this expanding field. From editor Mickey Smith: “Looking back on 40 years of experience, I’ve recently begun saying that most of the things I knew about pharmaceutical marketing over the years that made me so smart are not true anymore. But the fact is that the principles of marketing are as true as they were when they appeared in my first book (published in 1968). What has changed, and had to change, was the way the principles are applied. “This book is based on the premise that marketing follows certain principles and that pharmaceutical marketing is affected by a variety of environmental influences which lead to a rich array of marketing practices. These practices are presented to demonstrate how the successful application of marketing principles—with appropriate adaptation to environmental forces—can lead to success in the marketplace. Failures are also presented.” This well-referenced book explores and explains the principles and practical application of vital elements of pharmaceutical marketing, including: product pricing—with sections on trends, competition, reimbursement programs, public policy, and more research and development—including strategies relating to new products, product scope, positioning and repositioning, product elimination, diversification, and a fascinating case study about Ibuprofen promotion—rational and nonrational appeals, advertising prescription drugs to consumers, strategic choices among media types, budgeting, and more place factors, channel systems, physical distribution, and specialists and much more! Ideal for anyone entering or studying the pharmaceutical industry, Pharmaceutical Marketing: Principles, Environment, and Practice is a one-stop source of reliable knowledge that you’ll refer to again and again! In the editor's words, “Good marketing leads to good medicine. Exceptions exist, but when the system works, bad marketing never succeeds for long—and neither does bad medicine.”
This is thirty-fifth edition of Martindale, which provides reliable, and evaluated information on drugs and medicines used throughout the world. It contains encyclopaedic facts about drugs and medicines, with: 5,500 drug monographs; 128,000 preparations; 40,700 reference citations; 10,900 manufacturers. There are synopses of disease treatments which enables identification of medicines, the local equivalent and the manufacturer. It also Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines. Based on published information and extensively referenced
Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and definition of andmedicineand in different jurisdictions; and categories of medicines; and manufacturing and importation regulation in numerous jurisdictions worldwide; and inspection regimes; and good manufacturing practice (GMP); and marketing authorization; and manufacturing documentation; and complaints and product recall; and liability insurance; and protection of trade secrets; and data exclusivity and data protection; and deficiencies and delays; and and recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.
