Having a comprehensive understanding of your organization’s readiness to tackle any or all safety responsibilities is paramount.
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. Expectations of global regulators are increasing regarding ongoing, long-term safety assessments, signal detection and refinement. Are you ready?
UBC has assembled this “PV readiness” checklist to enable our clients to drive internal conversations around their safety strategies, and ensure they have a partner in place to help in any or all of these important categories of a safety organization.