This conference will facilitate a better understanding of the eCTD submission development process, eCTD submission standards, and their impact to business processes, as well as the future direction of eCTD
Horsham, PA (Vocus) October 10, 2008
The Drug Information Association's (DIA's) 7th Annual Electronic Submissions Conference ECTD: The Adventure Continues (November 5-7; San Diego, CA) will focus on the practical experience gained, lessons learned, and resulting best practices as the pharma industry moves to a fully electronic drug application submission paradigm.
"This conference will facilitate a better understanding of the eCTD submission development process, eCTD submission standards, and their impact to business processes, as well as the future direction of eCTD," explains Program co-chair Mary L. Collins, Director, Regulatory and Industry Relations, Image Solutions, Inc. "
Professionals who are relatively new to the electronic submissions process can attend track 1, which will include sessions on:
- Switch to eCTD (case studies)
- Outsourcing solutions
- Compliance of non-clinical and clinical study reports and data sets for eCTD submissions
- Practical publishing of eCTD
Track 2, created for the advanced professional, which will include sessions on:
- Data standards/CDISC
- Regulated Product Submissions (RPS)/Future of eCTD/International Conference on Harmonization (ICH)
- Strategies for global eCTD submissions
- Effective sCTDs: Maximizing resources, reusing documents, facilitating reviews
- Technology, compliance, and their impact
"On January 1, 2008, the Food and Drug Administration (FDA) mandated the eCTD format for all electronically submitted new applications and supplements," explains Program co-chair Gary M. Gensinger, Deputy Director, Office of Business Process Support, CDER, FDA. "Today, eCTD is also the preferred electronic format for submitting dossiers in the European Centralized Procedure."
Exhibiting companies specializing in the areas of document management, electronic submissions, and eCTD will present their products and services throughout the conference.
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, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.