Unravel and clarify how both document/information management and submission technology play a central role in the pathway from research to submission at the Drug Information Association's (DIA's) 22nd Annual DIA Conference for Electronic Document Management February 10-13 in Philadelphia, PA.

"Our industry is confronted with myriad technical standards and global regulatory requirements-coupled with new economic and virtualization concerns regarding the intelligent use of technology to create, manage, and submit vital information to regulatory authorities," says Program Co-chair Mary L. Collins, Senior Director, Regulatory and Industry Relations, Image Solutions, Inc. "The steady stream of technical developments and demands on our organizations can make staying current extremely challenging, "

Session topics will include:

* Document creation, management, delivery, repurposing, and archiving
* Submission document authoring, reuse, and submission assembly in collaborative and global environments
* Aligning standards and technology with the process and interoperability implications
* Leveraging eTechnologies to improve efficiency and quality in regulatory operations and submissions
* Managing transition during deployment and upgrading of document management systems and tools
* Trial Master Files (TMF) and eClinical records
* Defining and ensuring quality of documents throughout the research lifecycle and across all disciplines
* Metadata clarity and utility for presenting data in multiple views
* Optimizing the eCTD and SPL workflow
* Strategic submission and maintenance of INDs in eCTD format
* Creating NDAs and BLAs in eCTD format

Regulatory Authority Day will convene regulators from the US and EU to discuss current requirements for submission standards, processes, regulations, and guidance and present new initiatives and future directions within CDER and CBER related to PDUFA IV mandates, and common standards development, systems.

More than 30 exhibiting companies will present the latest electronic document management solutions.


About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit www.diahome.org.

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