Toronto, ON (PRWEB) February 6, 2009
i4i Inc., a world leader in the design and development of collaborative content solutions and technologies for life sciences will be showcasing their SPL R4 products and services on February 11th and 12th at booth #207.
Supporting i4i's commitment to the development of the SPL standard and to making a contribution to industry education, on February 13th at 10am Keith Thomas, i4i's Chief Product Strategist and SPL Working Group member will present "Lifecycle and Process Synchronization - Issues in the Management of Content of Labeling, e-Registration and e-Listing Submissions to the FDA". The learning objectives for this session include:
•Understanding SPL submission information flows: document types, content and processing rules;
•Understanding the information dependencies between e-registration, e-listing and labeling submissions and the coordination actions needed to ensure the required consistency.
Since its inception, i4i has championed the need for state of the art XML technology to support the FDA's SPL submission requirements and continues to lead the market for SPL products and services to ensure its customers remain compliant with the FDA requirements for registration, listing and content of labeling.
i4i's A4L Version 4 delivers a superior platform that supports a complete SPL R4 solution for all Life Science enterprises. A4L supports the full authoring, submission, validation and label management processes including support for Human Prescription Drug Labels (HPDL), Human Prescription Drug Labels with Highlights (HPDLH), NDC Labeler Code Requests, Establishment Registration and Listing SPLs as defined in the SPL Guidance Documents.
i4i is providing a complete solution to support the new SPL R4 regulatory requirements for all effected products:
- all human prescription drugs (HPD), proprietary & generic, with or without highlights, under CDER;
- all human over the counter drugs (OTC), under CDER;
- all biological products, such as blood products, vaccines, human tissue, under CBER and CDER;
- all veterinary medicines and medicated feeds, prescription or over the counter, under CVM.
i4i continues to play a leadership role in the development of the SPL standard, working closely with the FDA and industry. Information on the new SPL R4 requirements and i4i's release of products and services to ensure compliance is available by visiting us at Booth #207 or at http://www.i4i.com.
Based in Toronto, Canada, i4i (http://www.i4i.com) is a world leader in the design and development of XML-based collaborative content solutions and technologies. The company has a proven record of accomplishment and innovation having authored international standards and patented its technology. Through the use of i4i's comprehensive suite of products, life science companies can author, verify, submit and manage product labeling requirements across the globe. i4i has successfully developed and deployed collaborative content solutions to customers in life sciences as well as other industry and governments around the world.