WEBINAR | The Next Chapter in Global Risk Management and REMS

Global risk management is entering a new phase. Regulatory expectations are converging, evidence standards are rising and sponsors are under growing pressure to connect strategy with execution across markets.

In the webinar, The Next Chapter in Global Risk Management and REMS, experts examined what these shifts mean in practice and where sponsors may need to rethink their current approach.

The discussion centered on five questions that can help teams assess whether their risk management programs are ready for what comes next.

1. Can One Global Strategy Support Different Regulatory Models?

FDA and EMA expectations are becoming more closely aligned around structured benefit-risk assessment, measurable effectiveness and continuous lifecycle management.

That alignment creates an opportunity for sponsors to build a more unified global model across U.S. Risk Evaluation and Mitigation Strategies (REMS), European Union risk management plans and additional risk minimisation measures (aRMMs). It also raises important questions about where standardization works, where local adaptation remains essential and how teams can avoid creating new operational complexity.

2. Are Current Metrics Showing Activity or Effectiveness?

Distribution alone no longer tells the full story. Regulators increasingly expect evidence that risk minimisation activities reached the intended audience and contributed to the desired outcome. Sponsors need to look beyond whether materials were sent and consider what happened next.

Digital engagement data can provide a more meaningful view of program performance, but teams must determine which measures offer genuine insight and how those findings can support stronger decision-making.

3. How Much Visibility Do Teams Have Across European Markets?

Implementing aRMM educational and safety advice materials across Europe can quickly become fragmented. Country-specific expectations for distribution, outreach and documentation create pressure on teams to maintain local flexibility without losing global oversight. Manual processes and disconnected systems can make that balance harder to achieve.

A centralized approach can help sponsors improve control, consistency and visibility while preserving the flexibility required for country-level execution.

4. Is Technology Connecting the Program or Adding Another Layer?

Technology can improve traceability, oversight and reporting, but only when it connects the right activities. GRM Central from Syneos Health brings key risk management functions into a more connected environment designed to support governance, execution and inspection readiness across markets.

For sponsors evaluating their current systems, the more important question may be whether technology is creating a clearer line of sight across the program or simply adding another platform to manage.

5. Is the Organization Prepared for the Full Scope of a REMS Transition?

REMS transitions are rarely limited to a single system or vendor. They can affect data, processes, testing, governance and multiple operational dependencies. Gaps in planning may not become visible until implementation is already underway.

Early alignment on scope, ownership and coordination can help teams identify hidden risks, reduce disruption and protect program continuity.

See How These Questions Translate Into Action

The next chapter of global risk management will require sponsors to make deliberate choices about strategy, evidence, technology and execution. Watch the on-demand webinar, The Next Chapter in Global Risk Management and REMS, for a deeper look at the practical considerations behind each question and the next steps for sponsors.

---