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IATI - Israel Advanced Technology Industries
IATI News & Events Events Calendar Webinar: "It's all in the Details: Tips for Ensuring a Successful NDA Filing"

Webinar: "It's all in the Details: Tips for Ensuring a Successful NDA Filing"

Oct. 23, 2013

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"It's all in the Details:  Tips for Ensuring a Successful NDA Filing" 

Wednesday, October 23, 2013
12 p.m. (EDT) | 9 a.m. (PDT) | 5 p.m. (GMT) 

Online Registration 

 

When compiling an NDA for submission, it is common to focus primarily on the content of the technical sections, overlooking important administrative elements until late in the game.  This webinar will provide project managers with an overview of these administrative elements and offer tips on coordinating a timely and successful filing. 

 

Please join Dr. Robert Roth, M.D., Ph.D., Vice President and Worldwide Medical Consultant, The Weinberg Group, as he discusses:

  • The value of interactions with FDA
  • Required forms and certifications
  • Timing of waiver requests
  • Preparing clinical files for submission

This complimentary, one-hour webinar is designed to help pharmaceutical project managers understand the elements beyond the nonclinical, clinical and CMC content that are vital for NDA filing and review. 

To join the webinar, please register here.  Upon receipt of registration, a confirmation email with log-in information will be sent.

For more than 30 years, The Weinberg Group has served the global pharma industry, providing companies of every size with regulatory and compliance support.  Though much of our work is project-based, for some clients, we assume all regulatory responsibilities for a fixed monthly fee. This new service is called ORA, Outsourced Regulatory Affairs.

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