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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
John Geigert
€ 319.83
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Description for The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Hardback. .
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and ... Read more
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and ... Read more
Product Details
Publisher
Springer-Verlag New York Inc. United States
Number of pages
400
Format
Hardback
Publication date
2013
Condition
New
Number of Pages
338
Place of Publication
New York, NY, United States
ISBN
9781461469155
SKU
V9781461469155
Shipping Time
Usually ships in 15 to 20 working days
Ref
99-15
About John Geigert
John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member ... Read more
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