Advances in Pharma Business Management and Research, Violume 1

This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of master’s theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business. Preface Contents About the Editors Introduction: Trends and Developments in the Pharmaceutical and Life Sciences Industry Relevance of Instruments for Measurements of Quality of Life in the AMNOG Context: An Analysis of the Endpoint Health-Related ... 1 Relevance of Instruments for Measurements of Quality of Life in the AMNOG Context 1.1 An Analysis of the Endpoint Health-Related Quality of Life from Different Perspectives 2 Methods 3 Results and Conclusions 4 Outlook References Quality Management System for RandD Project and Portfolio Management in Pharmaceutical Company 1 Introduction 2 Theoretical Background 2.1 Theories 2.2 Pharmaceutical Project Management Quality System Model 2.3 Hypotheses 3 Empirical Analysis 3.1 Methodology 3.1.1 Characterization of PPMQS Enabling and Result Systems 3.2 Testing of Hypotheses 4 Empirical Findings 4.1 Characterization of Enabling and Result Systems 4.2 Testing of Hypotheses 5 Discussion References Brexit and Its Impact on Pharmaceutical Law: Implications for Global Pharma Companies 1 Brexit Scenarios 2 Impact on the Drug Regulatory Framework 3 Recommended Actions for Companies 4 Conclusions and Outlook References Implementation of Measurable and Sustainable Actions to Improve Employee ́s Engagement and Business Performance: Global Medical... 1 Background 2 Statement of Expectations 2.1 With Onboarding the Bond of Employees to the Company will be Increased 2.2 Regular Feedback Meetings with Superiors will Engage Employees 2.3 Personal Development Plans will Lead to Better Performance 3 Managerial Implications 3.1 Implications on Fresenius Kabi 4 Direction for Future Research 5 Conclusion References Leadership Models and Work Behavior: An Empirical Analysis of Consequences of Authentic and Transformational Leadership 1 The Importance of Leadership for Corporate Success 2 The Concept of Leadership 3 Constructs and Generation of Hypotheses 4 Empirical Assessment of the Models 5 Summary, Implications and Outlook References Alliance Management at Merck: Establishing an Operational 100-Day Plan for Alliance Launches and Management 1 Introduction 2 The Importance of Alliances for the Pharmaceutical Industry 2.1 The Problem ``Productivity Paradox ́ ́ 2.2 Cooperation as a Potential Solution 3 The Nature of Alliances 3.1 Definitions and Types of Alliances 3.2 The Lifecycle of Alliances 3.3 The Role of the Alliance Management 4 Merck KGaA and Its Alliances 4.1 History of Merck KGaA 4.2 Significant Biopharma Alliances of Merck 4.3 Alliance Management at Merck 5 The Operational 100-Day Plan 6 The Online Survey on the 100-Day Plan 6.1 General Statistics 6.2 Alliance Launch Phase 6.3 Governance of Alliances 6.4 Evaluation of Alliances 6.5 Feedback on the 100-Day Plan 7 Conclusion and Outlook Appendix 1: Operational 100-Day Plan for Alliance Launch References Correction to: Introduction: Trends and Developments in the Pharmaceutical and Life Sciences Industry Correction to: Chapter 1 in: L. Schweizer et al. (eds.), Advances in Pharma Business Management and Research, https://doi.org/... This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R & D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of masters theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business Chapter 1. Trends and developments in the pharmaceutical and life sciences industry.- Chapter 2. Relevance of instruments for measurements of Quality of Life in the AMNOG Context.- Chapter 3. The quality management system for R&D project and portfolio management in a pharmaceutical company.- Chapter 4. Brexit and Its Impact on Pharmaceutical Law - Implications for global pharma companies.- Chapter 5. Implementation of Measurable and Sustainable Actions to Improve Employee's Engagement and Business Performance - Global Medical Clinical & Regulatory Affairs (GMCRA) - A Role Model at Fresenius Kabi.- Chapter 6. Leadership Models and Work An Empirical Analysis of Consequences of Authentic and Transformational Leadership.- Chapter 7. Alliance Management at Merck - Establishing an operational 100-day plan for alliance launches and management.