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.
Product info
Series
Edition
Language
Place of publication
Publishing group
Springer International Publishing
Target group
Professional and scholarly
Illustrations
25
10 farbige Abbildungen, 19 s/w Abbildungen, 25 farbige Tabellen
25 Tables, color; 10 Illustrations, color; 19 Illustrations, black and white; XV, 70 p. 29 illus., 10 illus. in color.
Dimensions
Height: 235 mm
Width: 155 mm
Thickness: 6 mm
Weight
ISBN-13
978-3-030-57526-7 (9783030575267)
DOI
10.1007/978-3-030-57527-4
Schweitzer Classification
Dr. Catalano has over 37 years of experience in the pharmaceutical industry including positions such as Research Scientist, Group Leader Section Head, Associate Director ,Director ,Senior Director, and Consultant. He has managed the analytical support of Drug Substance and Drug Products, Pharmaceutical Development, Process Chemistry, Stability ,Assessment and Quality Assurance ( GMP, GLP, GCP ). His experience includes classical chemical and instrumental analyses, including MS hyphenated techniques such as GC/LC/MS, Solid State testing methodology and a thorough knowledge of cGMP's, GLP's, ICH guidance's, USP, NF, and other global compendia/guidance's. His leadership of several Global Pharmaceutical Sciences Teams for development projects involved directing the preparation of CMC documentation such as, IND, DMF, NDA, CTX, INDS, etc. for inclusion into regulatory documents, significant contributions to the registration of several currently marketed products e.g. Celebrex, Bextra, Dynastat, Inspra , Cytotec, Nutrasweet, Arthrotec, and the CMC CTD Global registration submission and approval for Telavancin ( Vibativ ) a peptide antibiotic. His academic work includes an adjunct professorship at St. John's University, College of Pharmacy and Allied Health Professions.
1. Introduction.2. Project Management Concepts.3. Theory of Constraints.4. Project Management Process.5. Risk Evaluation Process.6. Project Plan Implementation.7. Financial Project Management.8. Project Outsourcing.
