Spring Intro 2023

28/03/2023

Chemical Development / Quality

The Spring Introductory Course 2023

Hélène Foucourt, Associate Principal Scientist, International CMC, MSD

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Objectives

• The CMC Regulatory Affairs function – where it fits and core activity • Drug substance discovery and development • Drug Substance modalities and technologies • Drug substance: Detailed CTD requirements and applicable guidelines • Drug Product: types of dosage forms • Drug Product: Detailed CTD requirements and applicable guidelines • Pharmaceutical Development

• Drug Product Specifications and stability • Role of the CMC Regulatory Professional

The Organisation for Professionals in Regulatory Affairs

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