Module 12 Presentations

Current challenges in Regulatory Information Management

Historically, regulatory information has been managed in a multitude of systems, file shares, and/or intranet sites across the global, regional and local regulatory organizations. As a consequence, getting a global overview of key regulatory information and data has been a significant industry challenge . Challenges are also a result of low efficiency for data standards, governance management, dossier management as well as report and analytics.

7. Data quality

1. Staying current

RIMS

2. High administrative burden

6. Data governance

3. Manual and repetitive work

5. Disparate, aging systems

4. Breaking down silos

The Organisation for Professionals in Regulatory Affairs