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EDM and ERS 2014

Sep 22 2014 8:30AM - Sep 24 2014 1:00PM | Omni Shoreham Hotel 2500 Calvert Street NW, Washington, DC 20008 USA

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Overview 

Tutorials: September 21, 2014
Please monitor the DIA website for information and registration.


Following the success of last year’s combined EDM and ERS/eCTD event, EDM 2014 continues to explore evolving global trends in e-records, systems and e-context in the Clinical and Regulatory space. The rapid evolution of global electronic initiatives necessitates industry to continually assess internal processes to maximize content reuse and streamline efforts by pushing submission-ready and data standards farther upstream. As technologies and standards progress along with the real-time increasing volume of information, business paradigm has shifted many companies to investigate outsourcing solutions to remain competitive. Managing the associated risk, transparency, reliability and accessible document storage are essential elements for ensuring your organization’s compliance to current and emerging regulatory requirements.

To keep up with the changes in technology, advanced skill sets have become increasingly critical for personnel in the regulatory submissions and e-records space. In addition to their core skills, professionals in this field need to possess qualities like adaptability and business management skills as well as a high aptitude for learning multiple Information Technology (IT) systems and vendor management. To be successful in this fast-paced environment, it is critical to embrace change management and focus on continual improvement in both processes and professional development.

This conference serves as a forum for the discussion of emerging standards and the processes for submission creation and maximum use of regulatory information. Once again facilitated roundtable lunch discussions will be offered on industry hot topics as well as the “Ask the Regulators Session” to provide a venue to discuss hot topics with the Regulators and ask the panelists questions regarding FDA submission standards, processes, regulations, guidance, or initiatives (questions can be submitted ahead of time).


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


Highlights

  • Cross-functional sessions dedicated to the different areas of interest
  • Networking opportunities (reception, interaction with global regulators, cross-disciplinary networking)
  • Presentation of best practices
  • Exhibit hall
  • Interactive/collaborative sessions to share and develop ideas and experience
  • Learn from experiences of colleagues
  • Interact with Agency personnel

Who Should Attend 

Professionals who are involved in:

  • Regulatory Affairs and Operations
  • Global Submission Managers/Project Managers
  • Medical, Technical  and Regulatory 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
  • Vendor relationship managers

Special Offers 

EARLY BIRD RATE!
DIA Industry Members who register by
September 1, 2014, save $150!


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

 

Hotel & Travel 

Omni Shoreham Hotel  A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until August 29, 2014, or until room block is filled).  Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel.  Contact information for Travel Planners is as follows: Attendees can follow this link or call  +1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #14003.

Standard Room Rate $219

Hotel Address: 2500 Calvert Street, Northwest, Washington, DC 20008

PLEASE READ
Warning: Unauthorized Solicitation

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

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
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Exhibits
Jeff Korn, Exhibits Manager
Phone +1.215.442.6184
Fax +1.215.442.6199
Jeff.Korn@diahome.org 

Program Committee 

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Exhibits  

Booth Rental Fee US $3,500.00 per 8' x 10' Booth        

Exhibit Show Dates September 22-23, 2014
(booth installation: September 21st)
Omni Shoreham Hotel, Washington, DC

Booth Rental Fee Includes (per 8' x 10' booth space):

  • 1 Full-meeting Registration
  • 2 Booth Personnel Registrations
  • 6' Skirted Table
  • 2 Chairs
  • Wastebasket
  • Generic Identification Sign
  • Pipe and Drape Booth Space

Useful Links

  • ACUTA
  • Adlib
  • Cardinal Health Regulatory Sciences
  • EMC Corporation
  • Ennov Solutions, Inc.
  • EXTEDO
  • GlobalSubmit
  • Infotehna, Inc.
  • LORENZ Life Science Group
  • MedXview, Inc.
  • Mission3
  • Montrium
  • PAREXEL
  • Phlexglobal
  • PleaseTech Ltd.
  • QUMAS
  • RegDocs365
  • Veeva Systems

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$820.00
Member Government
$655.00
Member Industry
$1490.00
Member Industry (As of 09/02/2014)
$1640.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1045.00
NonMember Government
$880.00
NonMember Industry
$1865.00
Group Discounts

Register three individuals from the same company and receive complimentary registration for a fourth! All four 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 print a 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

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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