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.
Laura Brown, BSc, PhD, MBA, Diploma in Clinical Science, is a Director of LB Training and Development, an independent management consultancy and training organisation for the pharmaceutical industry. She is Director of the MSc programme in Clinical Research, School of Pharmacy at the University of Cardiff. She is also Director of TOPRA's MSc in Regulatory Affairs. Laura has 20 years' experience of the pharmaceuticals industry and has worked with GSK, Hoechst Marion Roussel, Good Clinical Research Practices and MDS. She has worked as a Life Cycle Project Manager, Clinical Research Manager, and as Head of Training for a pharmaceutical training company. Laura is co-author of five books on management and is author of the latest SCRIP report in GCP. Tony Grundy, MA, MBA, MSc, MPhil, FCA and PhD is co-Director of Cambridge Corporate Development, and is Visiting Lecturer in Corporate Strategy and Corporate Finance at Henley Business School. He is also academic advisor on TOPRA's MSC in Regulatory Affairs. Tony has researched the strategic and financial appraisal of major projects, and the strategic behaviour of teams involved in complex projects. He specialises in strategic thinking, strategic team working, and project appraisal in a variety of contexts, and has also consulted extensively in the pharmaceutical industry. Tony is author of 17 books.
'A comprehensive set of tools and techniques...The techniques and advice can be applied to many projects in the pharmaceutical industry, including drug development. This is particularly useful for managers who are looking to gain a new perspective for maximising project success...The importance of taking account of behavioural aspects for the successful running of pharmaceutical projects, often overlooked, is included...Above all, the case studies illustrate excellent techniques and principles to help the reader understand, and learn to use, modern tools and techniques for maximising management success. ' - Dr Carol Casman, Group Head, Transnational, Clinical Pharmacology and Discovery Medicine, GSK