Orbit’s annual community event, The Orbit Summit, was held on the first week of November. In this blog post, Kevin Fetterman, Senior Director of Business Development, recaps the industry panel on Risk Management. For more information about Orbit’s solution for Additional Risk Minimization Measures, see Orbit for PV Risk Management.
As part of this year’s Summit, we hosted a panel with three industry subject matter experts on the topics of Risk Management and additional Risk Minimization Measures (aRMMs). Facilitated by Feith’s SME, Michelle Peralta, and myself, we were joined by industry panelists:
- Meredith Y. Smith, PhD, MPA – Alexion Pharmaceuticals
- Dr. Romney Haylett – Merck Healthcare
- Carla Barrett, PharmD – PRA Health Sciences
Increased Attention to PV Risk Management
Risk management (RM) is expanding as a core function within Pharma/Biotech companies. In recent decades, RM requirements and commitments to regulators have continued their upward trend of complexity. Drug Safety departments have responded with increased attention to this vital function, expanding RM’s footprint and adding resources.
“We are in an accelerating period in regulatory expectation,” said Meredith Smith, describing MHRA and other health authorities’ recent attention to local implementation of aRMMs. “[Inspectors] need proof even several years down the line of what happened.” With this attention comes greater visibility within the organization, she later added: “There’s more appreciation for how we practice risk management and how critical it is in the overall risk-benefit of a product. It’s a great time and an exciting time to be in this area of drug safety.”
Are we nearing the apex in regulator attention? There are few signs of things slowing down. A growing number of health authorities outside of the EEA region are requiring companies to demonstrate that they have a robust risk management system in place. A cohesive and well-trained team is vital, particularly among local safety officers, who should be involved from the start.
Supporting Local Implementation
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. Therefore, success of the program entails close collaboration between the Global and the local affiliate teams.
Since local regulators may require variations in aRMMs, flexibility is needed in order to allow for a harmonized global strategy. To best manage this balance, teams should make continuous quality improvement a core part of their RM strategy. “Early on, there was a lot of manual review of the local implementation plans,” says Romney Haylett, describing her own team’s growth over the years. “Now people can work more on their own and ask for review. Orbit helps capture these differences as variations in local implementation. This is a very visible, embedded step in the system so the global team can review and give guidance.”
Strategies and takeaways
While each organization has their own method, the common elements in global RM remain the same across the board:
- Establish a global oversight team to facilitate Local RM activities
- Provide templates and tools for local teams so the Local Safety Officer or Affiliate has a clear understanding of the program’s goals and expectations
- Share effective training materials to accommodate different learning styles
- Define roles and expectations clearly, especially at a local level
- Put systems in place to support local teams and provide oversight
Carla Barrett and her team at PRA have found success by establishing a “Risk Management Toolbox” a package they share with local affiliates with all of the resources suggested above. Haylett and Smith offer their teams similar resources through their Local Implementation Plans and other materials.
When it comes to establishing a system to support global RM, our panel agreed that an effective platform, such as Orbit, is essential for enabling effective implementation, providing supportive oversight and ensuring compliance. Per Carla Barrett–“At the end of the day, having a system in place gives you a comfort level that for all of the activities you have in your RMP, you have appropriate documentation to demonstrate you implemented effectively. We are all here to minimize risk to patient safety… We all want to have the constant level of oversight and to do that we need a system that is reliable, robust, and that we can demonstrate to a regulator.”
