New Product Registration Tracking
- Date:
- Thursday, May 08, 2008
- Time:
- 2:00 - 3:00 PM EDT
- Presenter(s):
- Sparta Systems, Inc.
Who Should Attend:
- Research & Development
- Regulatory Affairs
- Information Technology
Agenda:
Expediting new product registration is key to achieving fast time-to-market and can be a strategic competitive differentiator for pharmaceutical and biotech companies. However, many organizations struggle to effectively manage this process or track related correspondence with regulatory bodies due to disconnected management and geographical disparity of regulatory activity, multiplicity of tracking mechanisms including unwieldy home-grown legacy systems, unorganized workload tasking etc. The potentially high volume of submissions due to the multitude of permutations of products, dosages, formulations and markets compound these effects even more.
After a brief introduction to Sparta Systems and TrackWise®, this webinar will discuss best practices for implementing a regulatory correspondence and task tracking system for new product registration.
A live TrackWise demonstration will show attendees how TrackWise:
- Centrally manages local geographical market activities, work assignments, deficiencies, submission packages
- Integrates with Change Management to automatically trigger and manage ongoing registration updates
- Introduces structure to the correspondence process and prevents issues from falling through the cracks
- Improves cycle times of approvals and routing
- Efficiently manages organization of workload and tasking
- Supports access with a “need-to-know” model to protect sensitive information
- Provides real-time notifications, escalations and transparency of activities