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

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Springer

Paru le : 2020-11-05

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 m...
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Éditeur

Collection
n.c

Parution
2020-11-05

Pages
70 pages

EAN papier
9783030575267

Auteur(s) du livre


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. 

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9783030575274
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