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Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options

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Overview 

Continuing Education credit or Certificate Program units are not available for Archived Webinars


Companies of all sizes will need to comply with FDASIA mandates for electronic submissions. While many companies have already begun this transition, many small companies and freelancers are facing these pending requirements with less resources and foundational knowledge. This webinar is focused on the medical writing tools and skills needed for creating eCTD and eCopy format submissions to FDA. This webinar is not focused on later steps of eCTD assembly and publishing, but on the myriad skills and tools needed to prepare e-submission-ready documents. The webinar will conclude with discussion on the various IT options for electronic submissions and the various deployment approaches including a full license, pay-per-submission models, and cloud environments.


This archive webinar will be available for purchase through November 30, 2014.

Featured Topics 

  • eSubmission-friendly document authoring skills and tools
  • PDF remediation skills and tools
  • Established and emerging IT options for eSubmission capability

Who Should Attend 

Professionals involved in:

  • Information technology
  • Medical writer/editor
  • Regulatory writer/editor
  • Regulatory operations specialist

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Recognize MS Word tools that enable generation of eSub-compliant PDFs
  • Explain FDA’s PDF standards and PDF remediation approaches to meet those standards
  • List vendor options for eSubmission IT solutions (for eCTD, eCopy) and of various deployment options

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Archived Webinar Details
Carolyn Callahan
DIA North America
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Tuesday, Dec 10, 2013

  • 7:00AM - 11:59PM

    Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options

    Speaker(s):

    • Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options
      E. Mitchell Seymour, PhD, RAC
      Research Faculty; Founder and Principal, R&D Advisors and SciMedLit, LLC
      University of Michigan Medical School , United States
    • Antoinette M. Azevedo
      President and Chief Executive Officer
      E-submissionssolutions.Com, United States

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Industry Individual
$250.00

Non-Member

NonMember Industry Individual
$295.00
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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