Pharmaceutical and Biomedical Project Management in a Changing Global Environment (Wiley Series on Technologies for the Pharmaceutical Industry)

PHARMACEUTICAL AND BIOMEDICAL PROJECT MANAGEMENT IN A CHANGING GLOBAL ENVIRONMENT......Page 1
CONTENTS......Page 7
FOREWORD......Page 11
PREFACE......Page 13
ACKNOWLEDGMENTS......Page 15
CONTRIBUTORS......Page 17
LIST OF ABBREVIATIONS......Page 19
PART I: OVERVIEW......Page 23
CHAPTER 1: PROJECT LEADERSHIP FOR BIOMEDICAL INDUSTRIES......Page 25
PART II: MANAGING MEDICAL AND PHARMACEUTICAL PROJECTS......Page 55
CHAPTER 2: MEDICAL DEVICES—COMPONENTS, SYSTEMS, AND THEIR INTEGRATION......Page 57
CHAPTER 3: THE ROLE OF PROJECT MANAGEMENT IN THE DEVELOPMENT OF IN VITRO DIAGNOSTICS......Page 75
CHAPTER 4: DRUG DEVELOPMENT PROJECT MANAGEMENT......Page 103
PART III: EFFECT OF BUSINESS RELATIONSHIPS ON MANAGING LARGE PROJECTS......Page 125
CHAPTER 5: OUTSOURCING OF PROJECT ACTIVITIES......Page 127
CHAPTER 6: THE UNIQUE ASPECTS OF ALLIANCE PROJECTS......Page 137
MANAGEMENT OF OUTSOURCING FOR BIOMEDICAL COMPANIES: AN OUTSOURCING CASE STUDY......Page 157
CHAPTER 7: A ROADMAP FOR SUCCESSFUL TECHNOLOGY TRANSFERS......Page 171
CHAPTER 8: CHALLENGES FOR THE TEAM LEADER OF MULTIFUNCTIONAL PRODUCT TEAMS IN AN INTERNATIONAL ENVIRONMENT......Page 197
CHAPTER 9: LESSONS LEARNED FROM INTER-ORGANIZATIONAL COLLABORATION PROJECTS......Page 209
CASE STUDY: PROJECT MANAGEMENT IN NON-PROFIT DRUG DEVELOPMENT......Page 231
PART IV: MANAGING UNIQUE PROJECT COMPLEXITIES......Page 237
CHAPTER 10: CLINICAL TRIALS AND PROJECT MANAGEMENT......Page 239
CHAPTER 11: ROLE OF PROJECT MANAGEMENT IN QUALITY PLANNING AND FUNCTIONS THROUGHOUT THE PRODUCT LIFECYCLE......Page 255
CHAPTER 12: REGULATORY STRATEGIES AND SUBMISSIONS IN AN INTERNATIONAL PRODUCT ENVIRONMENT......Page 273
CHAPTER 13: RISK MANAGEMENT—A PRACTICAL APPROACH......Page 305
PART V: PORTFOLIO MANAGEMENT AND RESOURCE PLANNING......Page 325
CHAPTER 14: MANAGING SUCCESSFUL PRODUCT PORTFOLIO CREATION AND R&D PIPELINES......Page 327
CHAPTER 15: EFFECTIVE STRATEGIES FOR PROJECT RESOURCE PLANNING AND UTILIZATION......Page 349
CHAPTER 16: STAGE GATE PRODUCT DEVELOPMENT PROCESSES AND LIFECYCLE MANAGEMENT......Page 361
PART VI: TRENDS IN BMI PROJECT MANAGEMENT......Page 367
CHAPTER 17: THE FUTURE OF MEDICAL DEVICES......Page 369
CHAPTER 18: THE NEXT WAVE OF MANAGING BIOMEDICAL PROJECTS......Page 381
INDEX......Page 395