P122: Development, Alignment, and Maintenance of Safety-informing Regulatory Documentation
Poster Presenter
Bhavana Tallavajhula
Director
Bristol Myers Squibb United States
Objectives
Discuss the product lifecycle for safety reporting; Identify the multitude of safety documents and the complexity of cross-alignment, coordinated updates, and ongoing maintenance; Describe the importance of management and communication of important new and evolving safety information
Method
Real-time management and harmonization of safety information across multiple safety-informing regulatory documents are critical to patient safety. This session presents challenges and opportunities for conveying a product’s benefit-risk.
Results
As a sponsor of clinical studies and as marketing authorization holder for approved products, it is our responsibility to ensure the safety of products for use by patients. This obligation begins with preclinical evaluation and continues throughout product marketing; continued vigilance is critical as more data become available from a broader patient experience in the real-world setting. Critical analysis of emerging safety information is key to the accurate characterization of a product’s safety profile, including the benefit-risk (B-R) profile.
The safety information we collect, analyze, and characterize is of key importance to regulators who have a comparable commitment to public health and safety. Starting with CIOMS through the finalization and implementation of ICH guidelines for the reporting of safety information, industry carries a regulatory obligation to report timely, harmonized, and consistent information on a product’s safety profile.
Conclusion
Various safety-informing document types at defined periods during and beyond drug development summarize the evolving picture of a product’s B-R and include the IB, DSUR, B-R Assessment Report, RMP, CTD documentation, product labels, and PBRER. For these documents, a re-iterative process continues throughout product use where we evaluate the consistency of new information relative to previous knowledge, assess the impact of new information on patient safety, and convey the current understanding and management of risks associated with use of the product. Given the unique qualities of each document type, comprehensive and consistent updates require expert understanding of the inter-relationships as well as meticulous coordination across these documents.
This session presents the challenges of management and harmonization of safety information across multiple regulatory documents. This presentation includes methods for cross-functional engagement and decision-making for accurate and timely information on risks and their mitigation.
