Module 12 2019

Target Operating Model (TOM)

The TOM is a concept • Concept takes the current regulatory submission process, but instead of submitting documents, application and product data (dataset) is generated and submitted as data • Applicants can either generate the dataset automatically from RIM, or manually in an User Interface, while re-using data that already exists • Agencies can upload the data structured in their systems (for those agencies that need the document they have it available and can use it)

The Organisation for Professionals in Regulatory Affairs