The Therapeutic Innovator

Abdoul Hamid Derra (Autor)

Buch | Softcover

220 Seiten

2025
International Book Market Service Ltd (Verlag)
978-620-3-90679-0 (ISBN)

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The term "ATM" is understood to refer to both advanced therapy medicinal products that have obtained a marketing authorization and advanced therapy medicinal products that are the subject of clinical trials or are used as a reference in a clinical trial (investigational advanced therapy medicinal product). If specific provisions only concern advanced therapy medicinal products that have obtained a marketing authorization, the term used is "authorized ATM". If specific provisions only concern investigational advanced therapy medicinal products, the term used is "investigational ATM". Nothing in this guide (including the risk-based approach) can be considered as constituting a derogation from the terms of the marketing authorization or the clinical trial authorization.

Abdoul Hamid Derra - Information systems engineer, entrepreneur, researcher, strategic studies developer, education advisor, maternal-child health, nutritionist.

Erscheinungsdatum	27.04.2025
Verlagsort	Beau Bassin
Sprache	englisch
Maße	152 x 229 mm
Gewicht	299 g
Themenwelt	Medizin / Pharmazie ► Allgemeines / Lexika
Themenwelt	Medizin / Pharmazie ► Gesundheitsfachberufe
Schlagworte	airlock • Batch • Bio Generator • Biological agents • Bulk Product • Calibration • Cell Bank System • Cell Culture • Cleaning Verification • Comparative analysis • Computerized System • containment • containment zone • Controlled Atmosphere Containment Zone • Controlled Atmosphere Critical Zone • Controlled Atmosphere Room • Controlled Atmosphere Zone • Controlled Zone • Cross Contamination • Drug • Exotic Organism • External Packaging • Fencing System • Finished Product • Finished Product Control • Founder Animal • Good Manufacturing Practices • herbal drugs • Immediate Environment • infected • Innovative Therapy Drug • In-process Control • Intermediate product • Isolator • Lot Number • manufacturer • Manufacturing • Manufacturing Campaign • Manufacturing Order • Master Cell Bank • medicinal plant • Packaging • Packaging Article • Primary Cell Bank • Primary Containment • primary packaging • Primary Seed Batch • Procedure • Production • Product Specification File • Qualification • Quality assurance • quarantine • Radio Pharmaceutical Drug • raw material • Raw Plant • Recovery • reprocessing • Return • Room Status • Secondary Containment • Seed Lot System • Separate Zone • Specified Pathogen Free • Starting Material • Sterility • Substantial Handling • Supplier Qualification • System • Validation • Working Cell Bank • Working Seed Batch • Zone
ISBN-10	620-3-90679-4 / 6203906794
ISBN-13	978-620-3-90679-0 / 9786203906790
Zustand	Neuware