The right strategy to continually evaluate product safety in your clinical trials, through regulatory review and entering the post-marketing setting, is complex. Are you PV ready?
Expectations of global regulators are increasing regarding ongoing, long-term safety assessments, signal detection, and refinement. The right strategy to continually evaluate product safety in your clinical trials, through regulatory review and entering the post-marketing setting is complex. Local market regulations are ever-changing. Technologies to intake, track, and manage workflow are getting more sophisticated.
Download our Global Pharmacovigilance Readiness Checklist to guide internal conversations around your organization’s safety strategies:
- Safety Systems
- Data Migration
- Global Case Processing
- Regulatory Reporting
- Period Reporting
- Products to Enhance Operational Delivery
- Signal Management & more