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

Dec 5 2013 11:00AM - Dec 5 2013 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET) 


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 

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

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 

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.

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

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

Name Credit Type Max Credits CEU
EDM and ERS/eCTD: Impact of e-Initiatives 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 Thursday, December 19, 2013.

To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE

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.

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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