Module 12 Presentations

Example: RIMS Reporting Capability

The reporting of data of a RIM system can help departments with decision making. It creates an overview of the current situation of regulatory data, and allows for further analysis (e.g., Are we on track? What is currently on the market?)

RIMS data

Variation

Status

Status date Status due date

Variation 1 NL

Approved

20/12/2023 01/01/2025

Variation 2 US

Submitted

21/04/2023 01/04/2024

Variation 3 GB

Submitted

05/08/2023 16/12/2024

Variation 4 EU

Planned

05/01/2023 07/05/2024

Other Reporting examples: 1) PSURs (e.g. due date/expiration) 2) Data quality (e.g. indications) 3) Overviews of all active registrations 4) WWMA reporting 5) Manufacturers (deadline)

Report

What Event/Variation is due?

• • •

Which are too late?

Which one is approved?

The Organisation for Professionals in Regulatory Affairs