The REMS Coordination Office (RCO) is the organizing hub among a Sponsor’s cross-functional team. The RCO is responsible for coordinating and tracking various aspects of REMS and the activities of outside service providers. The RCO features a core team of individuals tasked with managing REMS activities and processes.
This was the topic of a recent webinar hosted by ParagonRx. Jeff Fetterman, ParagonRx President, opened the webinar by borrowing two examples from the nuclear industry to illustrate how two different principles for organizing operational processes and systems have the potential for two different outcomes – flawless or disastrous. Applying these learnings to pharmaceutical industry management of Risk Evaluation and Mitigation Strategies (REMS), we can see how many companies may be setting themselves up for REMS disaster by failing to fully comprehend and address the coordination of activities and resources demanded for a successful REMS program. As Jeff explained, many companies focus all of their resources on REMS approval, but this is only half of the effort in a successful REMS program. The missing piece is effective post-launch implementation, which requires organizational excellence and effective resourcing. Many organizations struggling with REMS have one if not all of the following symptoms:
- Lack of dedicated risk management resources
- Lack of focus or commitment
- Inadequate planning
- Inadequate performance tracking
An RCO is one solution for a company facing these problems. An RCO dedicates staff and resources to risk mitigation activities, provides roles and accountability, and defines responsibilities and communications among the cross-functional teams. Establishing an RCO helps to prepare an organization to effectively and efficiently manage multiple programs throughout the complete lifecycle of the REMS.
The overview of the RCO was reinforced by case examples provided by members of ParagonRx who have had direct experience working for clients, in an RCO role. The examples highlighted the challenges and barriers REMS presented in their respective organizations and the unique circumstances facing the RCO.
Finally, the webinar concluded with a Q&A from our case example presenters, each explaining the position their client was in and how the RCO allowed the organizations to overcome these challenges, leading to effective and efficient management of REMS programs and activities.
To view the recording and/or slides from the webinar, visit www.paragonrx.com/rems-hub/forems.