Regulatory and Compliance Requirements for CMC Analytical Studies
About the CPD course
The first course in the online biopharmaceutical and biosimilar CMC analytical series. This course provides the foundations for course 2 and 3 in the series. Learn more about the series here. The course will provide you with regulatory and compliance clarity to ensure your analytical practices meet global requirements. Over 4 weeks you will learn what studies are needed and; crucially; when they must be completed to minimise development delays affecting your protein products (breakthrough or biosimilar). In addition; you will gain best practice as you transition from R&D laboratory analytics to GxP requirements gaining an appreciation of the data required and the risks involved.
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