FDA Promotional Materials Submissions in eCTD Format
Program Speaker:
Rachel Bombara
Sr. Regulatory Operations Specialist
Certara Synchrogenix
Event Agenda:
Date: Wednesday, 21 July 2021
Time*:
5:30 – 6:00 PM Virtual Networking
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A *Times are approximate.
Program Topic:
This informational presentation will help attendees assess if they’re prepared to submit promotional materials in eCTD format, which is the required format of all promotional materials submissions as of June 24th of this year. It will highlight the background information and basic requirements for these types of submissions. We will also discuss some common errors to avoid and tips for success moving forward. A short question and answer session will follow with participants. This presentation is geared towards entry-level, mid-level, and even experienced regulatory professionals interested in submitting eCTD submissions to CDER OPDP or CBER APLB.
Speaker Biography:
Rachel Bombara, Sr. Regulatory Operations Specialist, Certara Synchrogenix. She is a seasoned submission lead and publisher with a decade of experience in Regulatory Operations and helping clients achieve their submission goals. From small amendments to large-scale original marketing applications, she has worked with clients on a variety of different submission types, and ensured deliverables to health authorities are timely, of a high quality, and pass technical validation. Preparing promotional material submissions in eCTD and transmitting them via the FDA ESG is a service she regularly provides to clients.
Location:
Not applicable – This is an online event
Online registration (ends 20Jul2021): $10 SDRAN Member
$15 Non-Member
For Questions Email: [email protected]
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