Back to Agenda
Session 10 Track 1: Enhancing the Utilization of RIM with Emerging Use Cases
Session Chair(s)
Danielle Beaulieu, PhD
Senior Director, Global Regulatory Business Capabilities
Bristol-Myers Squibb, United States
Company additional Risk Minimization Materials (aRMM) is typically tracked as a safety process related to Risk Management plans. Efficiently following the milestones associated with aRMM often starts with the label changes and includes tracking the HA submissions, the approval / endorsement as well as the distribution of the materials. Much of this information can be found in a RIM system. This session will discuss setting up your aRMM tracking to facilitate linking it to both regulatory submissions/approvals, distribution, and to label changes. The session will also include a use case for configuring a RIM system to track aRMM, including the risk management strategy for an asset and risk management plan submission tracking throughout the product lifecycle, thereby closing the loop on tracking.
Learning Objective : At the conclusion of this session, participants should be able to:
- Analyze the process to ensure the material being created actively reflect the company position
- Recognize how RIMs can be used to track more than you think it can
- Recognize how to use RIMs to monitor risk minimization activities through the product lifecycle
Speaker(s)
Optimizing Additional Risk Minimization Measures (aRMMs) and the Direct Impact of End-to-End Labeling
Cham Williams, MS
IQVIA Technologies, United States
Associate Director, Safety, Regulatory and Quality Customer Engagement
Leveraging RIM to Monitor End to End Risk Management
Tracy Hernandez
Bristol-Myers Squibb, United States
Global Risk Management Lead, Publishing and Support
Have an account?