Regulatory information management (RIM) is an evolving practice. RIM has grown from its origins in document and registration management to a robust set of regulatory capabilities embodying people, process, technology, content, and data. RIM in its current context includes functionality to support the full product lifecycle and leverages data and metadata to provide valuable insights and drive regulatory effectiveness and performance. End-to-end RIM facilitates speed to market and helps ensure safe and effective products are available to patients.

This course will provide an overview of the RIM capabilities, its impact on the drug product development process, and what the future holds for regulatory affairs and RIM.

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