Webinar Date:  May 12, 2011    Time:  11:00 to 12:00 PST

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Summary:

In this webinar attendees will learn what they need to do in order to prepare for the new Module 1 and Validation Criteria updates being issued by the FDA. The eCTD Validation Criteria includes additions and deletions of error codes. The Module 1 updates are based on a history of eCTD submissions dating back to 2003.

Join us on May 12, 2011 as we discuss the following topics:

• The benefits of going electronic.
• How to check if your eCTD submission is valid
• Review of new and removed error codes
• Review of Module 1 changes
• Overview of new file formats and media types
• Grouped submissions
• Tips to prepare for the upcoming changes

Our Guest Speaker:

Harv Martins has over 31 years of experience in Life Sciences information systems development. For over 12 years he has served on the ICH M2 Expert Working Group.

Prior to joining EXTEDO, Harv served as Owner/President of ING America, where he worked with clients and regulatory agencies in the EU, Japan, Canada and the U.S. in the areas of eSubmission strategy, document and records management, tool and vendor selection, and software integration. He guided the development and marketing of GECCO, the leading eCTD Viewer / Validator software solution, which is now part of the EXTEDO product line. 

Harv also served for 5 years as Director of Data Management and IT at a major CRO. He also was Director of Operations at a startup online pharmacy system company for 7 years. He holds a degree in Electrical Engineering and is an active speaker at industry conferences promoting the development and use of standards. 

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