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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


SpringerBriefs in Pharmaceutical Science & Drug Development

von: Thomas Catalano

CHF 71.00

Verlag: Springer
Format: PDF
Veröffentl.: 05.11.2020
ISBN/EAN: 9783030575274
Sprache: englisch

Dieses eBook enthält ein Wasserzeichen.

Beschreibungen

<div>Dr. Catalano has for the last ten years been doing consulting for the Pharmaceutical Industry. During his consulting he discovered that small&nbsp;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. <i>Application of Project Management Principles to the Management of Pharmaceutical R&D Projects</i> is presented as a paper-based system for completing all the&nbsp;critical activities needed apply the project management system. This will allow these small business&nbsp;to take advantage of the project&nbsp;management principles and gain all the advantages of the system. This book will be beneficial for beginners to understand the concepts of project&nbsp;management and for small pharmaceutical companies to apply the principlesof project management to their business model.</div>
<p>Introduction.- Project Management Concepts.- Theory of Constraints.-Project Management Process .- &nbsp;Risk Evaluation Process.- Project Plan Implementation.-&nbsp; Financial Project Management.- Project Outsourcing.-&nbsp; List of Abbreviations.- Index.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</p>

<p><b><i>&nbsp;&nbsp;</i></b></p>
<p>Dr. Catalano has over 37 years of experience in the pharmaceutical industry&nbsp;including positions such as Research Scientist, Group Leader Section Head, Associate Director ,Director ,Senior Director, and Consultant.&nbsp; He has managed the analytical support of Drug Substance and Drug Products, Pharmaceutical Development, Process Chemistry, Stability ,Assessment and Quality Assurance ( GMP, GLP, GCP ).&nbsp;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.&nbsp;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 &nbsp;at St.&nbsp;John's University, College of Pharmacy and Allied Health Professions.&nbsp;</p>
Dr. Catalano for the last ten years has been&nbsp; consulting for the pharmaceutical industry. During his consulting he discovered that small&nbsp;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.&nbsp;<i>Application of Project Management Principles to the Management of Pharmaceutical R&D Projects</i>&nbsp;is presented as a paper-based system for completing all the&nbsp;critical activities needed apply the project management system. This will allow these small business&nbsp;to take advantage of the project&nbsp;management principles and gain all the advantages of the system. This book will be beneficial for beginners to understand the concepts of project&nbsp;management and for small pharmaceutical companies to apply the principles of project management to their business model.
Fills a niche in pharmaceutical development for start up companies Can be used with or without a software application as a paper based system Potentially reduces costs and increases effectiveness

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