DIA, North Bethesda, MD 20852
Mar 22 2010 8:00AM - Mar 23 2010 5:00PM
Location:
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
Interest Area(s):
CMC, Clinical Research, Clinical Safety/Pharmacovigilance, Nonclinical, Regulatory Affairs, Research & Development, Statistics
Overview:
FDA Forum to Promote Progress in Computational Science from Regulatory and Product Development Perspectives One of the most important and unrecognized issues contributing to drug development and regulatory productivity and quality is the ability to acquire, store, analyze, share and report information needed to make the most informed and rapid decisions in pharmaceutical companies, contract research organizations and international regulatory agencies. This meeting will review progress on topics such as data standards, best practices-driven analytical tool development, business processes driving information systems development, and user experience/evaluation of current tools. Highlights · Software Showcase and Demonstrations · Poster Presentations · Interactive Exhibit Hall · Half-day Parallel Tracks: · Pre-clinical development · Clinical pre-approval · Post-market safety · Product quality Learning Objectives:
At the conclusion of this meeting, participants should be able to: · Assess progress in data standards development and implementation between regulators and regulated industries; · Describe best practices for developing data submissions to facilitate effective and efficient regulatory review; · Outline the needs and proposed specification for new tools and solutions; and · Explain best practice (process, tools) implementation experiences and the subsequent impact on organizational performance.
Target Audience:
· Physicians · Biostatisticians · Epidemiologists · Clinical pharmacologists · Data management professionals · Information Technology professionals · Pharmaceutical industry (preclinical, pre-market, post-market development, regulatory, IT) professionals · Contract research organizations · Government organizations · Information management and bioinformatics professionals
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