Webinar Date: October 28, 2010     Time:  11:00 to 11:30 PST

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Summary:

More and more Regulatory Authorities are requiring that Life Science companies discontinue their paper-based submissions, in favor of electronically submitting clinical data supporting their product applications.  Leveraging and deploying available eCTD standards is the way to go if our clinical operations processes are ready for them.  Attempting e-submissions while not having lean clinical operations processes will result in faulty or inaccurate reports to regulatory authorities.  E-Submissions are the next natural step after attaining clinical operations integration makes both financial and regulatory business sense!

Join us on Thursday October 28, 2010 for a 30-minute presentation where we’ll gladly share our thoughts and experiences regarding:

• What we have learned from applying USDM’s “Simplify, Unify and Optimize” approach to e-submissions.
• E-Submissions of marketing approvals, safety reports and new drug applications.
• Regulatory requirements around e-submissions. 

Sponsored by the USDM Clinical Automation Practice Learn More

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