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

Dec 4 2013 11:00AM - Dec 4 2013 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


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.

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

Agenda Details
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@diahome.org

Event Logistics
JoAnn Boileau, Event Planner
Phone +1.215.442.6175
Fax +1.215.442.6199
JoAnn.Boileau@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; +1.703.506.3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 1 Elective Unit

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Electronic Submissions 101 IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, December 18, 2013.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits and Certificate Program units are not available for participation in the archived version of the webinar.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org

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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