Introduction to CMC Regulatory Affairs

Do you have problems finding the right course for staff who are new to the discipline of Chemistry and Pharmacy Regulatory Affairs? You don’t want new staff to be overwhelmed with information but they need to understand the type of data they will have to handle, what are the key issues to look out for and how to present this data in their submissions. This course is introductory for those with minimal experience in CMC or new to the discipline. Emphasis is placed on the CMC documentation in relation to the Clinical Phases and highlights how quality is relevant to safety and efficacy. This course will give delegates the understanding how to achieve good quality IMPD and MAA submissions.

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