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TOPRA NA- Ad Promo Submissions: Preparing for ECTD Mandate
The TOPRA IN North America Network is delighted to announce the upcoming webinar on Ad Promo Submissions: Preparing for the eCTD Mandate, presented by Allison Steffen, Regulatory Operations, WAYS Pharmaceutical Services.
Date
:
18 May 2021
Time:
16:30 – 17:30 BST (GMT+1) / 11:30 – 12:30 ET
Location:
Online
Presenter Profile
Allison Steffen
is a Regulatory Operations expert at WAYS Pharmaceutical Services. She is a University of Delaware graduate with extensive experience with the compilation and submission of eCTD drug applications. She has personally led over 50 original applications in the US, EU, and Canada, and supported subsequent life cycle activities. She also has experience with IND, NDA, BLA, MAA, NDS, PIP, DMF, ASMF, sNDA, Cross-Reference submissions, and Ad-Promo submissions.
Overview
On June 24, 2021, Ad Promo submissions that fall under
Section 745A(a) of the FD&C Act are required, by law,
to be submitted in eCTD format. Compiling these submissions in eCTD format can appear daunting, even to those well versed in standard electronic submissions. There are several unique metadata requirements, differences between submitting to CDER vs. CBER, and in some cases, additional documentation that needs extensive hyperlinking. This presentation will aid participants in utilizing the information contained in the final guidance to develop a strategy for the compilation of these submission types. We will touch on the activities allowed during the transition period, provide guidance on requirements for mandatory submissions, and highlight several publishing tips and tricks to ensure a valid and compliant final product. Modernizing Ad-Promo submissions to eCTD will be advantageous for both agency and industry alike, and it is imperative for sponsors to get familiarized with the process and define their approach moving forward.
Pricing
Members:
Free
Non-Members:
£45 - includes two months of TOPRA membership
When
18/05/2021 16:30 - 17:30
Where
ONLINE
Registration is closed.
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NOTE
Important instructions before booking -
If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email
finance@topra.org
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