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07/29/2009 by Nancy Smerkanich
Date: 11/15/2006 Length: 1 hour 30 min Size: 83.90MB eCTD's: Dos and Don'ts for CDER's Electronic Requirement Join Nancy Smerkanich, vice president of Regulatory Affairs, John Lawrie, vice president of Pro...
07/29/2009 by John Lawrie
Date: 10/11/2006 Length: 00:15:08 Size: 6.93MBJohn John Lawrie, Vice President, Process Solutions — Octagon Research Solutions, Inc. ...
07/29/2009 by Jim Walker
Date: 8/28/2006 Length: 3 min Size: 655KB SkyRadio host Dennis Michael interviews Jim Walker on the success of Octagon and its futur...
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The Growth Strategist

07/29/2009 by James Walker
Date: 4/11/2006
Length: 56:20
Size: 12.83MB

Growing Your Business Through Technological Advancements & Venture Capital

Join the Growth Strategist as she interviews James Walker of Octagon Research Solutions, Inc.  Learn how this INC 500 Company grew to 200 people and $25 million by developing an integrated suite of services to the life sciences industry- with the help of a venture capital company.

SkyRadio Interview with Octagon Chairman and CEO, Jim Walker

07/29/2009 by Jim Walker
Date: 8/28/2006
Length: 3 min
Size: 655KB

SkyRadio host Dennis Michael interviews Jim Walker on the success of Octagon and its future, its key goals and strategies to insure Octagons continued success.

Electronic Submissions and eCTD Challenges

07/29/2009 by John Lawrie
Date: 10/11/2006
Length: 00:15:08
Size: 6.93MBJohn

John Lawrie, Vice President, Process Solutions — Octagon Research Solutions, Inc.

Submitting drug applications electronically has many advantages, and the
industry is progressively adopting this practice as its standard. Learn how to
navigate the complex waters of eSubs and developing eCTD capabilities.

FDA News Audioconference

07/29/2009 by Nancy Smerkanich
Date: 11/15/2006
Length: 1 hour 30 min
Size: 83.90MB

eCTD's: Dos and Don'ts for CDER's Electronic Requirement

Join Nancy Smerkanich, vice president of Regulatory Affairs, John Lawrie, vice president of Process Solutions and Pam Pagnotta, principal consultant, Process Solutions at Octagon Research Solutions, Inc., during an FDANews audiconference presentation entitled: eCTDs: Dos and Don'ts for CDER's Electronic Requirement.

Listeners of this audioconference will receive a thorough explanation of the need for submission lifecycle management, which requires both technology and process understanding of the challenges of tracking and managing submissions over the lifetime of the application. Additionally, Octagon’s instructors will address the questions that have been created by the specifications and guidances. Understanding these, and how they have been answered in the field, can help provide a controlled, manageable transition to eCTD.