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EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context: FDA Update/Progress Report

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Overview 

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

This archived webinar will be available for purchase through June 30, 2014. Broadcast time is 1 hour 45 minutes.


This year’s EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context was directly affected by the government shutdown.  As a follow-up to the meeting, this webinar is being offered to deliver the FDA session content that would have been delivered at the meeting.  The webinar will focus on the FDA Update/Progress Report including an eCTD update and information on Data Standards.  The questions for FDA collected onsite at the conference were provided to FDA; they will be reviewed and also addressed as appropriate during the webinar.

The EDM and ERS/eCTD meeting brings together key opinion leaders in this industry to discuss emerging standards and the processes for submission creation and maximum use of regulatory information.


This program has been developed in collaboration with the Document and Records Management and Electronic Regulatory Submissions Communities.

Featured Topics 

  • eCTD Update
  • Quality and Product Data Standards
  • Study Data Standards Update
  • Top Ten Issues with Data

Who Should Attend 

Professionals involved in:

  • Regulatory Affairs and Operations
  • Global Submission Managers/Project Managers
  • Regulatory, Medical and Technical Writers
  • Data Managers
  • Information Technology and Support Personnel
  • Document and eRecords Managers
  • Regulatory Standards Implementation Specialists and Associates
  • Clinical Operations Representatives
  • Quality Assurance and Compliance Professionals
  • Contract Researchers and Service Support Providers
  • Emerging Pharmaceutical/Biotech/Device Professionals

Learning Objectives 

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

  • Discuss challenges for ensuring compliance to meet regional requirements
  • Explain current regulatory agency requirements and future initiatives
  • Describe the FDA’s plan and use of data standards

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-8:00 ET
CustomerService@diahome.org

For information on this archived webinar
DIA North America
Carolyn Callahan
Phone +1.215.442.6194
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Friday, December 13, 2013

  • 7:00AM - 11:59PM

    EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context: FDA Update/Progress Report

    Speaker(s):

    • DIA EDM Webinar eCTD Update
      Mark A. Gray
      Director, Division of Data Management Services and Solutions, OBI, CDER
      FDA, United States
    • Jared C. Lantzy
      Regulatory Information Specialist, DDMSS, OBI, OSP, CDER
      FDA, United States
    • Ron Fitzmartin, PhD,MBA
      Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
      FDA, United States
    • Douglas L. Warfield, PhD
      Interdisciplinary Scientist, DDMSS, OBI, OSP, CDER
      FDA, United States
    • Marci C. Kiester, PharmD,RPh
      Associate Director, Office of Prescription Drug Promotion, OMP, CDER
      FDA, 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.

Register Online

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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