Pharmaceutical Competitive Intelligence For The Regulatory Affairs Professional

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. ​

Master's Thesis from the year 2004 in the subject Health - Miscellaneous, grade: sehr gut, University of Bonn (Mathematisch-Naturwissenschaftliche Fakultät), language: English, abstract: The Regulatory Affairs (RA) department is a key discipline in the global network of drug development. During drug development, regulatory strategy is one crucial success factor for the approval of the development candidate. Also, regulatory strategy can optimise labelling in the key countries in order to maximise the market success. No submission and approval would be possible without the appropriate dossier composition and compilation. Without adherence to the respective guidance documents and scientific advice from Health Authorities to design the optimal clinical development plan, optimal labelling would not be feasible. These two examples show some characteristics of the regulatory strategy: it is highly interactive with other disciplines and it is heavily based on a thorough intelligence work which enables the RA Manager to know the "rules of the game" and to develop the optimal regulatory strategy for the current development candidate. The major cornerstone for developing a regulatory strategy is regulatory intelligence. This document focuses on regulatory intelligence. The regulatory contributions to the global drug development from early research to submission are described. Strategies for generic drugs as well as detailed strategies for life-cycle management are excluded. Major components of regulatory intelligence are: - Competitor Information - Information on Regulatory Environment - Information on Legal Requirements Competitor analysis is an essential aspect of the intelligence work. Sources of competitive information as well as relevant items of competitive information are described. Sources of information about the regulatory environment and sources of information about the legal regulatory environment are described and their tremendous impact on setting up and modify

This publication examines the role of competitive intelligence (CI) in the pharmaceutical industry. It is aimed at helping managers in both pharmaceutical and biotechnology companies better understand the role of CI and how best to manage it.Pharmaceutical and biotechnology companies are under constant competitive pressure from firms with competing drugs, both in-market and in development. Branded drugs only have a limited in-market lifetime; the firms that market them need to develop and execute highly effective sales and marketing strategies, especially since individual drugs can be turned into multi-billion dollar blockbusters. It is prudent that firms understand in detail the constantly shifting external competitive environment. The authors have interviewed leading CI practitioners in eight international companies, providing a mix of both large- and medium-sized pharmaceutical and biotechnology firms in both the U.S. and Europe. Moreover, both authors are CI professionals and have been practicing CI for some 15 to 20 years. They have, therefore, also incorporated some of their hands-on experience on how CI managers organize and manage their groups.

Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

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.

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