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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| Format: | Thesis (University of Nottingham only) |
| Language: | English |
| Published: |
2023
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| Online Access: | https://eprints.nottingham.ac.uk/76036/ |