Module 12 Presentations

Overview of RIMS and its benefits

Why is it important?

What are the benefits?

How does this apply?

✓ Decreased compliance risks ✓ Efficient use of data, authoring and submissions ✓ Immediate access to real-time information ✓ Reduced manual efforts ✓ Tracking of Health Authority communications ✓ Tracking of submission timelines and performances ✓ Accelerated time to market ✓ Improved internal communication and reporting

Compliance: Implementation of data standards (e.g. ISO IDMP) Controlled vocabularies to adhere to standards Product data quality: Re-usage of data from one central location Controlled vocabularies for uniform internal terminologies Quality of internal processes: All regulatory content in one location Streamlined E2E regulatory processes

Impacts all stakeholders involved in E2E regulatory process ✓ Contributing along the submission process ✓ From authoring, editing to approval of regulatory content

✓ Involves all activities

related to planning and tracking of submissions and post-marketing activities

The Organisation for Professionals in Regulatory Affairs