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• Nancy Smerkanich, vice president, Global Regulatory Affairs, Octagon Research Solutions, Inc., to serve as Tutorial Instructor, Session Facilitator and Discussion Leader during the Drug Information Association’s (DIA’s) 9th Annual Electronic Submission Conference: Working Together Towards a Global Strategy. (diahome.org).
• Ms. Smerkanich also serves as Program Co-Chairperson along with Gary M. Geisinger, director (acting), Office of Business Informatics, Center for Drug Evaluation (CDER), US Food and Drug Administration (FDA).
• This year collaborative sessions have been included in the conference program to focus discussions on key topics and enable greater interaction among attendees.
• The conference will be held 27-29 October 2010 at The Westin San Diego Hotel, San Diego, CA and Ms. Smerkanich will be instructing or facilitating discussions during the following sessions to be held during the conference:
Tutorial #1 – eCTD Basics
Role: Tutorial Instructor
Date: 27 October 2010
Time: 8:30 am – 12:00 pm PDT
Tutorial #3 – US INDs in eCTD
Role: Tutorial Instructor
Date: 27 October 2010
Time: 1:30 pm – 5:00 pm PDT
Session 6: Collaborative Sessions
This group of Collaborative Sessions are comprised of three concurrent sessions for various modules of the CTD. The M2.4/2.6/4 session is a discussion of required pre-clinical information.
Collaborative Session Break-Out 2: M2.4/2.6/4
Role: Session Facilitator
Date: 29 October 2010
Time: 1:00 pm – 2:00 pm PDT
Session 7: Discussion of Collaborative Sessions
This session serves as a wrap-up discussion where each group will offer a 10-minute presentation to summarize the discussion points of their breakout session.
Role: Discussion Leader
Date: 29 October 2010
Time: 2:00 pm – 3:00 pm PDT
• Octagon will also be exhibiting during the conference at Booth #10 and will provide demonstrations of its ViewPoint® enterprise process management solution, as well as its ViewPoint eCTD Complete and StartingPoint® its global submission document authoring template suite.
Supporting Quotes
‘I am honored to be working with such a respected team of industry professionals who are interested in sharing their experiences,’ stated Ms. Smerkanich, vice president, Global Regulatory Affairs. ‘I look forward to networking with industry colleagues and facilitating informative discussions as we work together to identify and address global submission challenges.’
‘I am excited that Nancy has the opportunity to share her global regulatory affairs expertise in support of this very focused Drug Information Association conference,’ commented Jim Walker, CEO and chairman, Octagon Research Solutions, Inc. ‘Global electronic submissions continue to be a topic of much interest to our industry colleagues. This opportunity allows us to share our industry expertise and continue to position Octagon as a leader in unifying clinical data and submission strategy for the global life sciences industry.’
About Octagon Research Solutions, Inc.
Octagon (octagonresearch.com) is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in London, UK. Octagon’s EDC Operations are located in Mountain View, CA.
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kbouldin[.]octagonresearch.com 
