Improving Safety Assessments Through Toxicology Data Management
A US based cosmetic company proactively began replacing talc with cosmetic-grade mica in all its products after FDA raised safety concerns due to presence of asbestos in some of its products. Safety concerns have also been flagged by US FDA in products of multiple US based cosmetics companies in the recent past, driving a clear need of improved safety assessment in light of recent data.
Today, product stewards face tougher-than-ever regulatory compliance obligations to ensure high safety standards. They must collect, integrate, analyze and manage scientific data to demonstrate that their businesses meet these safety requirements. While compliance may at first seem costly, the expense of non-compliance is far greater. According to the Ponemon Institute, the cost of non-compliance is about 2.7 times more than the cost of compliance- a difference of $14.82 million vs $5.47 million. In addition to the high price tag of non-compliance, the risk to health and safety can be dire.
At Product Stewardship 2019, experts Jared Dominak, Senior Client Executive for Chemical Safety Solutions at Evalueserve and Bijoy Varghese, Senior Toxicologist, Chemical Safety Solutions at Evalueserve will discuss how toxicology data management can improve safety assessments and save time.
In this session, Jared and Bijoy will address the challenges that product stewards face in toxicology/scientific data collection, data maintenance and data integration such as structuring and maintaining a repository of updated phys-chem and toxicology data and coordinating with suppliers to procure chemical specific supplier data. All of these requirements, along with integrating internal data with publicly available source data to maintain a structured and searchable repository of data, require advanced skills and effort.
Toxicology Data Management provides solutions for these problems. Safety is improved when data review is approached in a systematic way that integrates the “weight of evidence” into assessments. In addition, greater collaboration between multi-disciplinary experts such as pharmacologists, environmental toxicologists, human toxicologists and chemists improve safety standards. Cross-chemical industry knowledge also helps to design tangible strategies that can achieve more scientifically-driven safety assessments.
By sharing case studies of real companies that have enhanced their safety standards, Jared and Bijoy will explain how companies can benefit from one-stop access to accurate and comprehensive data through data management. These resources can help identify issues with the reported test material description. By identifying discrepancies, this process yields insights on test material, providing detailed summaries with appropriate solutions to address data gaps and more.
Learn how to walk through the data and compliance jungle in Jared and Bijoy’s session, improving safety assessments through toxicology data management.
Session: Improving Safety Assessments Through Toxicology Data Management
Date and Time: Wednesday, September 11; 9:30 – 9:50 a.m.
Location: Room A215