Module 12 Presentations

Successful regulatory information management

Successful regulatory information management is more than using a system (technology). Processes, information and organization are impacted.

PROCESSES INFORMATION ORGANIZATION

What is the Data Governance (DG) framework for your processes and data management?

What data / documents are required for you defined RIMS scope?

How do you want to use your RIMS from a business perspective?

PROCESSES

INFORMATION

What is the quality of this data (e.g. aligned to IDMP data standards)?

How will the DG framework be rolled-out in alignment with process implementation

Which processes are in scope?

TECHNOLOGY

What is the strategy for process implementation?

What data will you need for your submissions, is the current quality sufficient?

What is the change management strategy?

EXAMPLE: eAF variation submission

ORGANIZATION

Who is responsible to manage and ensure high quality compliant data?

When will you start using RIMS for regulatory data creation?

What eAF structured data must be maintained within your RIMS?

Successful regulatory information management is only possible in case all POTI aspects are considered

The Organisation for Professionals in Regulatory Affairs