Pharmaceutical and Biomedical Project Management in a Changing Global Environment

Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environmentexplores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development.  Written by experienced professionals, and including real-world approaches and best practi...

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Bibliographic Details
Main Authors Babler, Scott D, Ekins, Sean
Format eBook Book
LanguageEnglish
Published Hoboken, N.J Wiley 2010
John Wiley & Sons, Incorporated
Wiley-Blackwell
Edition1. Aufl.
SeriesWiley series on technologies for the pharmaceutical industry
Wiley series on technologies for the pharmaceutical industry.
Subjects
Medical
Medical instruments and apparatus industry
Personnel management
Personnel management > Methodology
Pharmaceutical industry
Pharmacology
Project management
Gesundheit Sonstiges
Medizin
Online AccessGet full text

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Table of Contents:
  • (Publisher-supplied data) 1: Project Leadership for Biomedical Industries/ Scott D. Babler -- 2: Medical Devices ? Components, Systems, and their Integration / Dennis F. Marr -- 3: The Role of Project Management in the Development of In Vitro Diagnostics / David Kern and Diane M. Ward -- 4: Drug Development Project Management / Dirk L. Raemdonck and Bradford A. Burns -- 5: Outsourcing of Project Activities / Jonathan D. Lee and Trisha Dobson -- 6: The Unique Aspects of Alliance Projects / Andrew S. Eibling -- Case Study: Management of Outsourcing for Biomedical Companies / Jeffery W. Frazier, Jennifer A. Hewitt and Andy Myslicki -- 7: A Roadmap for Successful Technology Transfers / Nipun Davar, Sangita Ghosh, Nandan Oza -- 8: Challenges for the Team Leader of Multifunctional Product Teams in an International Environment / Hartwig Hennekes -- 9: Lessons Learned from Inter-Organizational Collaboration Projects / Andrea Jahn -- 10: Clinical Trials and Project Management / Scott E. Smith, Carol A. Connell and Dirk L. Raemdonck -- 11: Role of Project Management in Quality Planning and Functions Throughout the Product Lifecycle / Thomas Dzierozynski and Ian Fleming -- 12: Regulatory Strategies and Submissions in an International Product Environment / Louise Johnson -- 13: Risk Management - A Practical Approach / Courtland R. LaVallee -- 14: Managing Successful Product Portfolio Creation and R&D Pipelines / Sue E. Steven -- 15: Effective Strategies for Project Resource Planning and Utilization / Eduardo Rojas and Scott D. Babler -- 16: Stage Gate Product Development Processes and Lifecycle Management / Karen E. Coulson -- 14: Managing Successful Product Portfolio Creation and R&D Pipelines / Sue E. Steven -- 15: Effective Strategies for Project Resource Planning and Utilization / Eduardo Rojas and Scott D. Babler -- 16: Stage Gate Product Development Processes and Lifecycle Management / Karen E. Coulson.
  • PHARMACEUTICAL AND BIOMEDICAL PROJECT MANAGEMENT IN A CHANGING GLOBAL ENVIRONMENT -- CONTENTS -- FOREWORD -- PREFACE -- ACKNOWLEDGMENTS -- CONTRIBUTORS -- LIST OF ABBREVIATIONS -- PART I: OVERVIEW -- CHAPTER 1: PROJECT LEADERSHIP FOR BIOMEDICAL INDUSTRIES -- PART II: MANAGING MEDICAL AND PHARMACEUTICAL PROJECTS -- CHAPTER 2: MEDICAL DEVICES-COMPONENTS, SYSTEMS, AND THEIR INTEGRATION -- CHAPTER 3: THE ROLE OF PROJECT MANAGEMENT IN THE DEVELOPMENT OF IN VITRO DIAGNOSTICS -- CHAPTER 4: DRUG DEVELOPMENT PROJECT MANAGEMENT -- PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGE PROJECTS -- CHAPTER 5: OUTSOURCING OF PROJECT ACTIVITIES -- CHAPTER 6: THE UNIQUE ASPECTS OF ALLIANCE PROJECTS -- MANAGEMENT OF OUTSOURCING FOR BIOMEDICAL COMPANIES: AN OUTSOURCING CASE STUDY -- CHAPTER 7: A ROADMAP FOR SUCCESSFUL TECHNOLOGY TRANSFERS -- CHAPTER 8: CHALLENGES FOR THE TEAM LEADER OF MULTIFUNCTIONAL PRODUCT TEAMS IN AN INTERNATIONAL ENVIRONMENT -- CHAPTER 9: LESSONS LEARNED FROM INTER-ORGANIZATIONAL COLLABORATION PROJECTS -- CASE STUDY: PROJECT MANAGEMENT IN NON-PROFIT DRUG DEVELOPMENT -- PART IV: MANAGING UNIQUE PROJECT COMPLEXITIES -- CHAPTER 10: CLINICAL TRIALS AND PROJECT MANAGEMENT -- CHAPTER 11: ROLE OF PROJECT MANAGEMENT IN QUALITY PLANNING AND FUNCTIONS THROUGHOUT THE PRODUCT LIFECYCLE -- CHAPTER 12: REGULATORY STRATEGIES AND SUBMISSIONS IN AN INTERNATIONAL PRODUCT ENVIRONMENT -- CHAPTER 13: RISK MANAGEMENT-A PRACTICAL APPROACH -- PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING -- CHAPTER 14: MANAGING SUCCESSFUL PRODUCT PORTFOLIO CREATION AND R&amp -- D PIPELINES -- CHAPTER 15: EFFECTIVE STRATEGIES FOR PROJECT RESOURCE PLANNING AND UTILIZATION -- CHAPTER 16: STAGE GATE PRODUCT DEVELOPMENT PROCESSES AND LIFECYCLE MANAGEMENT -- PART VI: TRENDS IN BMI PROJECT MANAGEMENT -- CHAPTER 17: THE FUTURE OF MEDICAL DEVICES
  • CHAPTER 18: THE NEXT WAVE OF MANAGING BIOMEDICAL PROJECTS -- INDEX