Podcasts
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.
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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.
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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.
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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.
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