Part A: General overview of Regulatory Affairs/ Part B: A comparison of the CMC regulatory submission requirements in Europe and USA for small molecules and Biologics

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Part A: General overview of Regulatory Affairs/ Part B: A comparison of the CMC regulatory submission requirements in Europe and USA for small molecules and Biologics

Part A: The European Medicines Agency (EMA) requires an Investigational Medicinal Product Dossier (IMPD) to be submitted for the initiation of a clinical trial for a medicinal product in Europe. In the USA, an Investigational New Drug (IND) application needs to be submitted. The harmonised Common T...

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Bibliographic Details
Main Author:	Perera, Uduwa (Roshane)
Format:	Thesis (University of Nottingham only)
Language:	English
Published:	2023
Subjects:	Biopharmaceutics Biopharmaceutical industry biologics
Online Access:	https://eprints.nottingham.ac.uk/76036/

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