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Strategies for Regulatory Starting Materials Designation in Drug Development and Manufacturing

Strategies for Regulatory Starting Materials Designation in Drug Development and Manufacturing

Strategies for Regulatory Starting Materials Designation in Drug Development and Manufacturing

In this video, the speakers will discuss expectations of regulators on the selection of RSM and the justification of their designation in the pharmaceutical supply chain. In addition, the scope of presentation of RSMs required in regulatory filings and how to prepare for “push backs” in the event of a major objection to the sponsor’s RSM designation will be examined.