Module 12 Presentations

Regulatory data throughout the product lifecycle

Regulatory data is captured throughout the life cycle of a product. Data captured during the pre clinical and Clinical phases is tracked in detail within eTMFs and Clinical Data Management solutions. Data is typically tracked in a RIM once a product is being prepared for Marketing Authorisation Applications. Once a product is commercial , capturing the details of what is approved and where is critical for patient safety and all life cycle maintenance activities are planned and tracked via a RIMS

High-level life cycle of product master data

The Organisation for Professionals in Regulatory Affairs