Application of Project Management Principles to the Management of Pharmaceutical R&D Projects (SpringerBriefs in Pharmaceutical Science & Drug Development)
Language: English
Published by Springer, 2020
Series: Book 13 of 13 - SpringerBriefs in Pharmaceutical Science & Drug Development
- Softcover
- Used
Seller: Books From California, Simi Valley, CA, U.S.A.Books From California
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- Title
- Application of Project Management Principles to the Management of Pharmaceutical R&D Projects (SpringerBriefs in Pharmaceutical Science & Drug Development)
- Author
- Catalano, Thomas
- Publisher
- Springer
- Publication year
- 2020
- Condition
- Very Good
- Binding
- paperback
- Language
- English
- ISBN 10
- 3030575268
- ISBN 13
- 9783030575267
- Series
- Book 13 of 13: SpringerBriefs in Pharmaceutical Science & Drug Development
"Synopsis" may belong to another edition of this title.
About the Author
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.
"About the title" may belong to another edition of this title.
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