Why risk, why now?
All eyes are on Risk Management. Can you manage the scrutiny?
PV teams are relying on passive tools, like spreadsheets and email, to manage their critical processes and commitments. This is even true in risk management, where the stakes couldn’t be higher.
Orbit bridges the gaps left by standard PV systems, connecting your global and local teams. With Orbit, you can share strategies and tools across all of your local markets while monitoring adaptations and deviations in local plans. Only Orbit supports local implementation of additional Risk Minimization Measures in the same seamless interface with your other safety commitments.
“A straightforward and dependable way to manage what are often complicated logistics around compliance obligations.”
Safety IT Director, Top 10 Pharma
Risk Management Plans
Harmonize your global risk management plans
Orbit stores structured RMP details, giving your team total oversight of global variations in safety specifications, commitments, and timelines. With reminders and notifications, staying ahead of your RMP commitments is simple — as is monitoring global progress and implementation metrics.
Demonstrate compliance across all markets with automated, meaningful reports on your global risk management system.
- Core RMP
- dRMP
- REMS (US)
- EU RMP
- Local RMP
- J-RMP
Additional Risk Minimisation Measures
Local implementation
Support local implementation of risk minimisation measures like Educational Materials. Orbit gives global safety teams the tools they need to manage a core strategy, guide local safety teams to a successful implementation, and oversee global process metrics.
Only Orbit offers a connected solution to manage RMPs and implement their most challenging and highly regulated commitments.
Manage core implementation plan
Share information and guidance
Oversee local implementation metrics
Blog
RMP and REMS: The Most Stringent Risk Minimization Measures – Restricted Distribution
Background The past two decades have seen a fundamental “swing
Insights from Orbit Summit’s Risk Management Panel
The distributed nature of aRMMs is a key challenge to implementation: it requires having a cohesive strategy and plan for implementing local RM activities. As was quickly pointed out, the effectiveness of RM programs is dependent on how well the programs are implemented at the local country level.
Structured data collection: the next step in risk minimization tracking
From evaluating effectiveness to tracking global implementation status, and rooting out non-compliance with SOPs at your favorite affiliate, collecting data has become a necessity for Tracking Systems.
Connected trackers
Document Exchange
Automatically send updated RMPs to partners based on your Safety Data Exchange and PV Agreements.
Safety Commitments
Track Safety Commitments and Health Authority Requests across Regulatory and PV functions.
Areas for Close Monitoring
With integrated MedDRA browsing, manage lists of safety concerns with structured query strategies.
Learn why Orbit is the top choice for Risk Management.
Schedule a call today.
