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FDA’s Center for Veterinary Medicine Announces Second eSubmitter Webinar in Ongoing Series

FDA’s Center for Veterinary Medicine Announces Second eSubmitter Webinar in Ongoing Series

August 7, 2018

On August 22, 2018, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) will host the second of a three-part webinar series to provide information on how to use eSubmitter, CVM’s electronic submission tool for the animal drug approval process.

CVM is providing this webinar series because, starting on October 1, 2018, sponsors will be required to use eSubmitter to submit all animal drug applications to the agency. This second session will assist and educate sponsors on how to use eSubmitter to create various types of animal drug application submissions. The first webinar in the series walked users through the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS) registration processes. The last session, to be held in September, will provide additional opportunity for questions and answers.

The webinar will be live-cast and a recording will be available on the FDA website shortly after the presentation date. Registration prior to the webinar is not required. The webinar will be open to the first 500 participants.

The webinar will be held on the Adobe Connect platform. CVM strongly encourages attendees to test their computers well in advance of the webinar to ensure their computer and network connections are properly configured. Please visit https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.

Webinar 2: How to Use the eSubmitter Tool

Wednesday August 22, 2018: Time: 9 AM - 4 PM EDST

Morning Session

To access the morning session of the webinar, use the following link: https://collaboration.fda.gov/cvmesubwebinar4/

Introductions/Agenda: 9:00 – 9:05 am

Overview of Electronic Submission Process: 9:05 – 9:15 am

How to Use eSubmitter: 9:15 - 11:15 am

  • Downloading and installing CVM eSubmitter

  • Launching eSubmitter and basic navigation

  • Creating a new submission

  • Using the address book feature

  • Understanding business rules (activating/deactivating questions based on responses)

  • Attaching files

  • Finalizing and packaging a submission

  • Submitting to CVM and viewing CVM Reponses

  • Question and Answer

Special Scenarios: 11:15 – 11:35 am

  • Creating a new file/application

  • Product description

  • Amendment process

  • G submission vs. GC document

Where to go for help: 11:35 – 11:50 am

Q/A: 11:50 am – 12:00 pm

BREAK 12:00 – 1:00 PM

AFTERNOON BREAKOUT SESSIONS: 1:00 PM – 4:00 PM

Afternoon breakout sessions will focus on walking users through how to use CVM eSubmitter to create the submission types listed below.

Animal Bioengineering and Cellular Therapies (ABCT) Team

To access the webinar, use the following link: https://fda1.webex.com/fda1/j.php?MTID=ma20283873f6e9d931e077391de2f4fb0.

1:00 – 1:30: INAD-A-OT
1:30 – 2:00: VMF-A-OT (Type VII)
2:00 – 2:30: ABCT Technical Sections Introduction
2:30 – 3:00: INAD-P-DP
3:00 – 4:00: INAD-P-PC

Chemistry, Manufacturing and Controls 1

To access the webinar, use the following link: https://fda1.webex.com/fda1/j.php?MTID=m0106acb56babd4d101aa1839b49c7a5f.

1:00 – 2:30: INAD-P-MC
2:30 – 4:00: JINAD-P-MC

Chemistry, Manufacturing and Controls 2

To access the webinar, use the following link: https://fda1.webex.com/fda1/j.php?MTID=mc584f8291e15d50f58dcc61943f70df3

1:00 – 3:00: VMF-A-OT (Type II and Type V)
3:00 – 4:00: (A)NADA Post Approval Submissions (Supplements, MCSR)

Target Animal Review Divisions 1

To access the webinar, use the following link: https://fda1.webex.com/fda1/j.php?MTID=m7c7a76502a8290da131e79ed15a523d6

1:00 – 1:15: INAD-A-OT
1:15 – 1:45: INAD-E’s
1:45 – 2:00: INAD-O-OT
2:00 – 3:00: ADAA Combination Submissions
3:00 – 4:00: NADA-A-OT Free Choice Feeds

Target Animal Review Divisions 2

To access the webinar, use the following link: https://fda1.webex.com/fda1/j.php?MTID=m2a7d66aed9fd7bd74304df5ac00b0a73

1:00 – 1:30: INAD-M’s
1:30 – 2:00: NADA-A-OT
2:00 – 4:00: Meeting Requests (Z Submissions)

Environmental/Target Animal Review Divisions 3

To access the webinar, use the following link: https://fda1.webex.com/fda1/j.php?MTID=m3c4930d4c61d46c331f9edb4c4937151

1:00 – 1:15: INAD-X-CE
1:15 – 2:00: INAD-P-NV
2:00 – 4:00: INAD-P-EF

Generic Review Division

To access the webinar, use the following link: https://fda1.webex.com/fda1/j.php?MTID=m07712165e84a166ac03cbbec1e3ecec3

1:00 – 1:30: JINAD-A-OT
1:30 – 2:00: JINAD-Z-OM
2:00 – 4:00: ANADA-A-OT

Other Related Materials

eSubmitter Webinar 1: FDA ESG and CVM ESS Registration Process resources

Recording of Webinar 1: https://collaboration.fda.gov/p35sg2mj6sk/

For information about submitting electronically to CVM, please see the Electronic Submissions webpage.

To download eSubmitter, visit: CVM eSubmitter Program.

If you have any questions regarding electronic submissions, email CVM’s Electronic Submissions Support Team at cvmesubmitter@fda.hhs.gov.

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.