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Live Webinar Using the Pre-Submission Process to Your Best Advantage Date: Wed, December 3, 2014 Instructor:Elisa Harvey
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
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Location: Online
Overview: This webinar will provide a detailed discussion of understanding the scope of the pre-submission process, what information to provide in a pre-submission, how to prepare for a pre-submission interaction with FDA and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.
Areas covered in the session: Understanding the scope of the pre-submission process What information to provide in a pre-submission How to prepare for a pre-submission interaction with FDA How to follow up with FDA following a pre-submission interaction
Who Will Benefit: Regulatory Affairs Professionals All companies developing manufacturing and marketing medical devices in the US
About Speaker Elisa Harvey Senior Regulatory Consultant, CardioMed Device Consultants, LLC Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry.
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