IQ Consortium Open SEND Session at the Society of Toxicologists (SOT) 54th Annual Meeting
The International Consortium for Innovation and Quality in Pharmaceutical Development DruSafe group (IQ Preclinical Safety) will be cosponsoring the IQ Consortium Open SEND Sessionat the Society of Toxicologists (SOT) 54th Annual Meeting from 12-2 pm PT on March 23, 2015, held in San Diego, CA. The other cosponsors include CDISC and PhUSE.
Manchester Grand Hyatt San Diego
Regatta Conference Rooms ABC
One Market Place
San Diego CA, 92101
**Food and beverage will not be provided. Please bring your own lunch.**
ABOUT THIS SESSION:
With the issuance of the FDA Draft Guidance in February 2014 regarding the provision of regulatory submissions in electronic format as defined in section 745A (a) of the Federal Food, Drug and Cosmetic Act the requirement for SEND (Standard Exchange of Nonclinical Data) is imminent. While a universal, standard for presentation of nonclinical data provides many opportunities including analytics, visualization and data sharing, there are multiple operational and IT challenges to overcome when implementing. Across the pharmaceutical industry, organizations are facing many of the same fundamental questions. What are the processes and procedures for information compilation? What is the best way to manage multi-site studies or the varying degrees of SEND-readiness for different facilities? Are these data sets in scope for GLP compliance? How can having data in this format benefit each organization individually and the industry as a whole? This meeting will be an excellent opportunity to share experiences, learn from companies that are well along the way to becoming SEND-ready and open the dialog between organizations (Pharmaceutical, Biotechnology and CROs), to establish a common platform for managing universal challenges. Speaker topics include: managing multisource data, multiple data formats, and the metadata associated with these submissions; GLP Compliance; Data warehousing, visualization, and analytics; and SEND from an IT perspective.