Project Management for the Pharmaceutical Industry

Project Management for the Pharmaceutical Industry
Author: Laura Brown
Publisher: Routledge
Total Pages: 0
Release: 2016-09-30
Genre: Medicine
ISBN: 9781138247420
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Written firmly from the perspective of the pharmaceutical industry, Laura Brown and Tony Grundy offer a guide to the tools and techniques of project management. They cover both the technical and human aspects of project management to provide clinical research, drug development and quality assurance managers or directors with a must-have reference.

Project Management for the Pharmaceutical Industry

Project Management for the Pharmaceutical Industry
Author: Mr Tony Grundy
Publisher: Gower Publishing, Ltd.
Total Pages: 299
Release: 2012-09-28
Genre: Business & Economics
ISBN: 140945908X
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The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.

Application of Project Management Principles to the Management of Pharmaceutical R&D Projects

Application of Project Management Principles to the Management of Pharmaceutical R&D Projects
Author: Thomas Catalano
Publisher: Springer Nature
Total Pages: 79
Release: 2020-11-05
Genre: Medical
ISBN: 3030575276
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Dr. Catalano has for the last ten years been doing consulting for the Pharmaceutical Industry. During his consulting he discovered that small businesses such as, generic, startups, and virtual companies do not have the budget or the resources to apply the computer software utilized in project management and therefore do not apply project management principles in their business model. This reduces their effectiveness and increases their operating cost. Application of Project Management Principles to the Management of Pharmaceutical R&D Projects is presented as a paper-based system for completing all the critical activities needed apply the project management system. This will allow these small business to take advantage of the project management principles and gain all the advantages of the system. This book will be beneficial for beginners to understand the concepts of project management and for small pharmaceutical companies to apply the principles of project management to their business model.

Generic Drug Development Project Management

Generic Drug Development Project Management
Author: Sandeep Narayan Patil, PMP
Publisher: Notion Press
Total Pages: 281
Release: 2021-04-17
Genre: Medical
ISBN: 1638067554
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This is the first book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book includes generic drug development project in detail. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
Author: Hamid Mollah
Publisher: John Wiley & Sons
Total Pages: 432
Release: 2013-02-01
Genre: Science
ISBN: 1118514343
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Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Leadership Competencies Of A Clinical Trial Project Manager

Leadership Competencies Of A Clinical Trial Project Manager
Author: John Petrera
Publisher: Fulton Books, Inc.
Total Pages: 132
Release: 2024-06-17
Genre: Business & Economics
ISBN:
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"Leadership competencies of a clinical trial project manager" is unique in that this qualitative inquiry research project not only explores the specific top leadership competencies of project managers involved in pharmaceutical clinical trials, but the concepts reviewed in this book are applicable broad spectrum to multiple professional fields. The proposed leadership framework combines elements of leadership competencies, project management competencies, personal competencies, and includes a review of the leadership types from the traits theory of leadership. The leadership concepts described are universal and can be applied to improve any leader's abilities. While this book focuses on clinical trial project managers, the concepts and best practices apply to all PMs within pharmaceuticals or in any other field. The derived PM competency framework is transferrable to PMs in numerous industries and may also provide applicable guidance to others, regardless of their profession. Ultimately, the expansion of the PM triangle is a useful concept that many will find interesting. Additionally, personal competencies can improve personal effectiveness, achievements, and actions. This project identified 5 themes to include (a) CTPM experience and knowledge, (b) leadership competencies, (c) leadership types (styles), (d) personal competencies, and (e) project management competency development (PMCD). The 5 themes identified are all critical to understanding the perspectives obtained from the study participants regarding leadership competencies to maximize efficiencies of research and development. The results of this study can (a) potentially assist new CTPMs, (b) provide a refresher for CTPMs seeking improvement, (c) provide support for project managers in general, and (d) may assist hiring managers in determining the leadership skills to seek. The results from this study may support the project, program, and portfolio managers from various industries to better understand the leadership competencies and the overall framework that support project management. At the same time, these 5 themes, interpreted in the broadest terms, may be helpful to you!

Pharmaceutical Project Management

Pharmaceutical Project Management
Author: Anthony Kennedy
Publisher: CRC Press
Total Pages: 274
Release: 2008-03-17
Genre: Medical
ISBN: 104006292X
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Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration

Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries

Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries
Author: Pete Harpum
Publisher: John Wiley & Sons
Total Pages: 358
Release: 2010-04-05
Genre: Science
ISBN: 0470049669
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This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.

Building Project-Management Centers of Excellence

Building Project-Management Centers of Excellence
Author: Dennis Bolles
Publisher: AMACOM Div American Mgmt Assn
Total Pages: 258
Release: 2002-09-06
Genre: Business & Economics
ISBN: 9780814426449
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It’s been shown again and again that business components from R & D to systems, engineering to manufacturing can benefit from a project-centered management approach. Now, organizations that have had success at the departmental or divisional level are taking the project management approach to new levels, adopting PM standards into across-the-board management philosophies and business strategies. This new model is known as the Project Management Center of Excellence. PMCoEs need every group within the organization to work under the PM model, but more important, they need the proper tools to implement PM standards in new areas. A crucial tool in developing project management objectives across the company, this book covers: * Positioning project management as a business strategy * Creating and managing an organizational PM portfolio * Education, training, and internal PM certification programs * Classifying projects, benchmarking, and mapping a methodology

Pharmaceutical and Biomedical Project Management in a Changing Global Environment

Pharmaceutical and Biomedical Project Management in a Changing Global Environment
Author: Scott D. Babler
Publisher: John Wiley & Sons
Total Pages: 283
Release: 2011-01-06
Genre: Medical
ISBN: 1118058216
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Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores 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 practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.