“It’s All in the Details: Tips for Ensuring a Successful NDA Filing”
A Webinar Presented by The Weinberg Group
Wednesday, November 2, 2011
12 p.m. (EDT) | 9 a.m. (PDT) | 4 p.m. (GMT)
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:
Marla Scarola, M.S., Senior Consultant and Lauren Wind, M.P.H, Senior Consultant
Topics will include:
- 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 dial-in number and log-in information will be sent.
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