P222: Development of an Effective Repository of the Company Core Risk Management Strategy
Associate Director, Global Risk Management
Bristol Myers Squibb United States
We discuss the value of documenting and maintaining a Company Core Risk Management Strategy (CCRMS) for medicinal products in a Regulatory Information Management System (RIMS) to support worldwide implementation.
We compared 2 options for the repository of the CCRMS. Option 1: a Health Authority-submissible global Risk Management Plan (RMP) template based on the EU RMP template. Option 2: a simpler document, residing in RIMS, not submissible to health authorities, but efficient to update as required.
The Health Authority-submissible global RMP (based on the EU RMP template), as a comprehensive document, facilitates local submissions with limited local writing resources. It can be submitted as is, or local market content can be added either directly into the document or as an annex. In practice, however, for some products with frequent submissions, it is challenging to maintain as the repository of the company risk management strategy as it evolves (changes or updates of indications, exposure, and safety data). It requires a high level of medical writing resources and must go through the review and approval process each time it is updated.
To increase the efficiency of this process we designed the CCRMS to reside in RIMS. The CCRMS is a high-level summary of safety concerns, along with routine and additional risk minimization measures (aRMMs) and additional pharmacovigilance activities (APVAs), in a non-submissible format. The CCRMS is the repository of the company risk management strategy formerly contained in the global RMP. Changes to the CCRMS can be documented, reviewed, approved, and communicated more quickly, compared with the global RMP. Reviews, approvals, and communications regarding the CCRMS are tracked by the system and are easily accessible to users. Thus, option 2 is a simple, brief document in a format that is not submissible to health authorities but addresses the disadvantages of option 1 in that it is more easily updated when there is a change to the risk management strategy for a product.
While the CCRMS is used to guide the development and update of submissible regional and local RMP documents as per country requirements, it is not a comprehensive document, and local/regional content cannot be added directly. Medical writing resources would be required to develop a local or regional RMP.
Company data are used to determine the company position on the safety profile of a product, as well as the corresponding routine risk minimization, aRMMs and APVA in the RMP. The non-submissible format (option 2) fulfills the same purpose as the submissible version (option 1): having the company risk management position living in a document. Option 2 provides other potential advantages, such as the format can be tailored to meet company needs (e.g., adapted to track country-specific information), and can be efficiently updated at any point there is a change to the risk management strategy.
The CCRMS is used to guide the development and update of submissible local/regional RMP documents as per country requirements. The fact that the CCRMS resides in RIMS has, qualitatively, improved the efficiency of processes for documentation and maintenance.
Co-authors: Nina Ramdas, Tracy Hernandez, Jayanthi Rao, Helen Prent, Marie Raphaelle Moazazi, Susanna Carou-Keenan, Robyn James, and Jenny Hamilton