Commercialization of BioPharma Products in the USA-A Practical Guide (2nd Edition) The discovery, development, and commercialization of a biopharmaceutical product are highly complex processes. The product manufacturing, distribution, and marketing activities must be flawlessly executed to ensure commercial success The commercial environment requires collaboration with diverse stakeholders such as patients, providers, payers, and policy makers to create value for the product. The commercial success of a product is critical in maximizing its potential and the shareholder return. This book outlines commercial imperatives, strategic choices, as well as cardinal imperatives for success along each step of the BioPharma value chain. It shows how pharmaceutical and biotechnology companies can achieve differentiated positioning for their products in this value-driven competitive healthcare environment in the USA. It's intended for anyone involved in commercial decisions in the BioPharma sector.
Quality management is a complex process, especially in healthcare. Managers in today's environment need more than just an understanding of the historical concepts of quality. They need to understand how to achieve quality within the structure and relationships of the complex system of a healthcare organization. In this new third edition, Kelly has enhanced the content to promote an understanding of systems thinking in health services organizations. While still providing readers with the foundational concepts of quality management, she instructs readers on the system implications of understanding stakeholders and the role of policy, establishing goals in complex systems, improving and managing process change, performance measurement, and teamwork. Readers learn how to think critically using new frameworks, approaches, and tools and are given real-life examples and case studies to practice these skills. This edition features new and enhanced material, including: # Alternative assumptions to traditional quality management tools and techniques # An expanded Practice Lab with which readers can exercise newly learned quality techniques # A guide to using the CMS and Joint Commission quality indictors to improve systems of care # A glossary of terms # Additional case studies and exercises designed to individualize applications in the student's own practice setting
Products Liability: Problems and Process offers a problem-based approach that balances doctrine with in-depth exercises that prompt students to apply the law in realistic fact scenarios. Rules and comments from the Restatement (Third) of Torts: Products Liability for which two of the authors, James Henderson and Aaron Twerski, have served as co-reporters are fully integrated throughout the text. Brief dialogs among the three authors present a range of perspectives on controversial issues within the field to help stimulate reflection and discussion. The book concludes with a chapter on products liability in a global context.
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