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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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About Us

Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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Rostrum Training Solutions Ltd

24 Lansdowne Road
Tilehurst
Reading
Berkshire
RG30 4QU

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