The Drug Information Association (DIA) and the US FDA will host the first DIA/FDA CDER/CBER Computational Science Annual Meeting from March 22-23 in Bethesda, MD.
Experts from the US FDA Centers for Drug and Biologics Evaluation & Research (CDER, CBER) will deliver updates on:
- Quality metrics and cases regarding data submission quality
Process and tools designed to assure adequate data quality supporting a successful review
Specifications for new tools
Effectiveness of current tools
Need-driven levels of tool training
Impact of processes and tools on problems solving quality, efficiency, and cost
Regulatory data submission that are efficiently loaded into the Janus warehouse
FDA and sponsor needs and plans
Development of a bioinformatics FDA platform enabling electronic regulatory review of routine submissions and emerging safety and product quality concerns
In addition to the featured meeting topics, breakout sessions will drill down and explore the requirements, standards, tools, and activities needed to support specific aspects of drug development. These breakouts will form the nuclei of working groups that can collaborate on an ongoing basis to discuss issues and create solutions in these five areas:
- Preapproval – Nonclinical: Current state of practice and steps forward for review of pharmacology/toxicology information in support of premarket regulatory review of drugs and biologics.
Preapproval – Clinical: Future informatics review state and the use of standardized data to improve drug review.
Post-market Safety: Needs, challenges, and solutions for three major aspects of handling postmarketing safety data: data efficiencies, analytic approaches, and oversight of postmarketing inspections and data verification.
Product Quality: Current use of computational tools and technologies to facilitate rapid, in-depth understanding of product quality data, and exploration of future opportunities.
- Data Quality: Advances in computational methods for detecting risks to data quality and public health
“The ability to acquire, store, analyze, share, and report information is one of the most important and unrecognized issues that contribute to drug development and regulatory productivity and quality,” says Program Co-chair Stephen E. Wilson, DrPH, CAPT. USPHS, Director, Division of Biometrics III, CDER, FDA. “We invite you to participate in a forum where stakeholders will review progress in areas such as data standards, best practices-driven analytical tool development, business processes driving information systems development, and user experience/evaluation of current tools.”
ABOUT THE DRUG INFORMATION ASSOCIATION (DIA)
DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, academic, and regulatory professionals. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
Contact: Joe Krasowski