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Electronic Submissions: The Next Era of Electronic Submissions

Nov 9 2014 8:30AM - Nov 9 2014 5:00PM | Bethesda Marriott 5151 Pooks Hill Road, Bethesda, MD 20814 USA

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Overview 

As part of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the reauthorization of the Prescription Drug User Fee Act (PDUFA V), there will soon be a mandate for the use of electronic submissions, specifically the electronic common technical document (eCTD) in the US.  There already exists a mandate in Europe for marketing applications that are eligible for Centralized Procedure review.  Electronic submissions are accepted globally in various formats and there are well established standards being used for their creation.

This course will focus on the technical foundations of electronic submissions and their use as well as the practicalities and processes of creating them.  The use of technology and the specifications needed for various types of submissions will be presented along with common issues and challenges.  The US requirement for the submission of datasets will also be addressed.

Examples of how standards can be employed to generate and track applications will be discussed, and activities on locating current guidance and submission metadata will all be part of this interactive course.

Course Level: Beginner

Key Topics: 
eSub/eCTD Guidance, vocabulary and terminology, document and data standards, mapping from regulation to submission

What You Will Learn 

This course will bring professionals with no experience up to date on all aspects of electronic submission and will address US specific requirements as well as the status in the rest of the world and the future of eCTD.  The course is technology and vendor neutral and will employ hands on use of basic software and internet use only.  This offering will be taught by an industry expert in regulatory affairs and electronic submissions and who specializes in training and education.

Who Should Attend 

This training course is designed for professionals working in regulatory operations and regulatory affairs, as well as for project managers, medical/technical writers, quality assurance and IT.  This course content would also benefit professionals working in drug development and marketing authorization.

Learning Objectives 

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

  • Describe the technologies that make up the foundation of electronic submissions
  • Recognize document and data standards and how to apply them
  • Identify electronic submissions by region and type
  • Use eCTD and eSUB vocabulary with ease and confidence
  • Discuss the structure of CTD/eCTD and the required content
  • Identify process change and change management needs

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Hotel and Course Location / Information

Bethesda Marriott
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until October 24, 2014, or until room block is filled). Attendees must make their own hotel reservations.

Standard Room Rate $169

Hotel Address: 5151 Pooks Hill Road, Bethesda, MD 20814, USA
Phone: +1-301-897-9400

The most convenient airport is Ronald Reagan National and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org
 
Agenda Details and Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Faculty 

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Continuing Education 

DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer .7 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:
• Project Management Certificate Program: 8 Elective Units
• Regulatory Affairs Certificate Program: 4 Elective Units

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

Name Credit Type Max Credits CEU
Electronic Submissions: The Next Era of Electronic IACET 6.50 0.700

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 attend the activity, sign-in at the DIA registration desk each day of the activity, and complete the online credit request process through My Transcript at www.diahome.org . 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 two weeks after the last day of the activity.
Please note: If you do not sign-in, you will not receive CE credit as partial credit will not be awarded.

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

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$470.00
Member Government
$470.00
Member Standard
$940.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$695.00
NonMember Government
$695.00
NonMember Standard
$1165.00
Group Discounts

Printable Registration Form

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.

To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Register Online

Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.

Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.

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.

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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