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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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Agenda  

Day 1 Monday, Sep 22, 2014

  • 8:00AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • Gary M. Gensinger, MBA
      Deputy Director, Office of Business Informatics, CDER
      FDA, United States
    • Betsy Fallen, RN
      United States
    • Christian A. Buckley, MBA, RAC
      Associate Director, Regulatory Operations
      Astellas Pharma Global Development, Inc., United States
  • 8:30AM - 10:00AM

    Plenary Session 1 - FDA Update


    Session Chair(s):

    • Gary M. Gensinger, MBA
      Deputy Director, Office of Business Informatics, CDER
      FDA, United States

    Plenary Session 1 - FDA Update

  • 10:30AM - 12:00PM

    Plenary Session 2 - Other Regions Update


    Session Chair(s):

    • Hans van Bruggen, MSc
      Director and Senior Regulatory Affairs Consultant
      eCTDconsultancy and Qdossier, Netherlands

    Plenary Session 2 - Other Regions Update

  • 1:30PM - 3:00PM

    Session 1 Track 1 - Leveraging the eCTD for Global Efficiency


    Session Chair(s):

    • Christian A. Buckley, MBA, RAC
      Associate Director, Regulatory Operations
      Astellas Pharma Global Development, Inc., United States

    This session will share best practices in preparing eCTD (and CTD) submissions for multiple regions. For competitive advantage, it is critical for global companies to maximize registrations across multiple regions. The eCTD format was intended for efficient reuse and this session will explore the realities involved. Topics include decisions regarding simultaneous submissions, readiness and evaluating regional publishing support. It is also important to plan for life-cycle maintenance in a global context and how to handle non-eCTD submission in some regions.

  • 1:30PM - 3:00PM

    Session 1 Track 2 - Collaboration & Integration: Facilitating Internal - External Interactions and Processes


    Session Chair(s):

    • Daniel F. Orfe, MS
      President and CEO
      Regulatory eSubmissions, LLC, United States

    The Pharmaceutical and Biotechnology industry is continuing an evolution of expanded decentralization where numerous disparate enterprises are engaged to produce, gather and assemble the information required by the drug/biologic development process. This session explores the tools, processes and procedures enabling and enhancing collaboration. The distinct points of view of a Software/Services company, Regulatory Services Organization and a major Pharmaceutical enterprise will be explored.

  • 1:30PM - 3:00PM

    Session 1 Track 3 - Why Would Anyone Adopt an eTMF?


    Session Chair(s):

    • Betsy Fallen, RN
      United States

    Many organizations are still working in the paper world of Essential Documents. There are costs associated with the era of mailing, scanning and archiving paper documentation. This session will assess the business, financial and compliance aspects of eTMF adoption.

  • 3:30PM - 5:00PM

    Session 2 Track 1 - Organizational Transformation of Enterprise Systems and Standards


    Session Chair(s):

    • Laura J. Sherman, MBA
      Training Partner, Clinical Business Operations
      Vertex Pharmaceuticals, Inc., United States

    This session will explore practical approaches for implementing technology solutions and standards to improve visibility, agile responsiveness, compliance, and user adoption. With any global enterprise software/system deployment, the planning phase is a critical element for a smooth transition rollout which can then be evaluated using metrics and lessons learned. Organizations are looking to gain operational efficiencies and interoperability, integrating technology and the business process. One case study will highlight the importance of documents reuse, including information metadata and DIA reference models. The other two case studies will focus on enterprise system implementations. Strategies and lessons learned on comprehensive approaches for managing organizational transformational change will be shared.

  • 3:30PM - 5:00PM

    Session 2 Track 2 - Outlining the Pathway to a Paperless Trial


    Session Chair(s):

    • Betsy Fallen, RN
      United States

    While the clinical development landscape looks for efficiencies, significant time and resource allocation might be optimized by moving from a paper to a paperless environment. This transition is challenging and presents people and process barriers to overcome. Identification and adoption of regulatory guidance or business process along with supportive technology are all enablers along the way. This session will advise audience members on best practices for implementing paperless technologies at each stage of the clinical trial process. Presenters will discuss case studies of early adoptions in paperless trials from a sponsor and site perspective. The regulators perspective of the application of the eSource guidance will be presented

  • 3:30PM - 5:00PM

    Session 2 Track 3 - Establishing Processes and Controls to Ensure an Inspection-Ready TMF Every Day


    Session Chair(s):

    • Lisa D. Mulcahy
      Owner and Principal Consultant
      Mulcahy Consulting LLC, United States

    Problems with TMF quality can now be a critical finding during a regulatory inspection; further motivating life sciences organizations to ensure their TMFs are inspection ready at all times. This session provides real-life case studies from two companies who have adopted an electronic, integrated TMF approach to enable inspection readiness. Speakers will explain why direct access to the eTMF is critical for all stakeholders, and describe how they use remote access to provide internal and external parties with the appropriate level of access to submit, collect, QC, and approve trial documents.

Day 2 Tuesday, Sep 23, 2014

  • 8:30AM - 10:30AM

    Session 3 Track 1 - Managing the Practical Impacts of Mergers & Acquisitions: Approaches to Process and Systems Integration in Clinical, Regulatory, and Quality


    Session Chair(s):

    • Stacy J. Tegan
      Senior Consulting, Strategic Consulting
      Accenture, United States

    Session 3 Track 1 - Managing the Practical Impacts of Mergers & Acquisitions: Approaches to Process and Systems Integration in Clinical, Regulatory, and Quality

  • 8:30AM - 10:00AM

    Session 3 Track 2 - Case Studies: Using the ‘Cloud’ to Support Electronic Document Management (EDM), Electronic Regulatory Submissions (ERS) and Regulatory Information Management (RIM) Activities


    Session Chair(s):

    • Daniel F. Orfe, MS
      President and CEO
      Regulatory eSubmissions, LLC, United States

    This session provides an exploration of how the “Cloud” is being leveraged to support document management, electronic submission production and Regulatory Information Management within the pharmaceutical and biotechnology industry. The distinct points of view of the Pharmaceutical industry, Software/Service industry and Clinical Research Organization will be explored through the use of real world case studies on how the “cloud” paradigm change is being leveraged. Critical aspects to consider when seeking to realize the positive potential of the “cloud” will be discussed.

  • 8:30AM - 10:00AM

    Session 3 Track 3 - e/TMF Reference Models: Interactive Colossus


    Session Chair(s):

    • Fran Ross
      Associate Director, Clinical & Regulatory Optimization
      Paragon Solutions, United States

    Join this interactive session to hear the latest information about activities and plans for the TMF Reference and OASIS eTMF Interoperability models. Experts will deliver hands-on practical advice about TMF Reference Model adaption: adding types, recommended vs core, differentiating metadata in eTMF, etc. Bring your war stories of model implementations, detailed questions such as “what about doc type xxx”, your considerations for TMF alignment, and share best practices for both paper and eTMF maturity and interoperability with your industry colleagues. This interactive discussion will drive future model activities; our success depends on your expert opinion and detailed feedback.

  • 10:30AM - 12:00PM

    Session 4 Track 1 - Managing and Developing Regulatory Submission Operations


    Session Chair(s):

    • Christian A. Buckley, MBA, RAC
      Associate Director, Regulatory Operations
      Astellas Pharma Global Development, Inc., United States

    Ensuring success in regulatory submission operations requires a diverse set of technical and business skills.. As a result, the regulatory operations space has evolved into a respected professional career and function critical to product registrations. This session will explore managing the developing global regulatory operations groups from several perspectives including hiring and training staff, vendor evaluation, and budget requirements.

  • 10:30AM - 12:00PM

    Session 4 Track 2 - Creating a Sustainable Global Clinical Research Collaborative Network


    Session Chair(s):

    • David Loose
      Vice President
      Essex Management, United States
  • 10:30AM - 12:00PM

    Session 4 Track 3 - Progression and Utilization of the DIA EDM Harmonization Effort (Reference Models)


    Session Chair(s):

    • Emily Onkka
      Director, Regulatory Operations/Project Management
      GlobalSubmit, United States

    This session will provide an update on the current status of the DIA EDM Harmonization Efforts including areas of further development. The session will include case studies and implementation examples, as well as discuss how overlapping content is managed when it is repurposed across two areas, such as TMF and regulatory submissions.

  • 1:30PM - 3:00PM

    Session 5 Track 1 - IDMP Part 1: Are you ready for IDMP? The Technical Perspective


    Session Chair(s):

    • Christian A. Buckley, MBA, RAC
      Associate Director, Regulatory Operations
      Astellas Pharma Global Development, Inc., United States

    Life Sciences companies must soon comply with IDMP, requiring cross-functional collaboration, cooperation and integration to gather, cure, and submit required data. In this session, the speakers will address the following topics:
    • Provide an overview of IDMP. The subject of Pharmacovigilance and product listings is evolving rapidly from local standards such as FDA’s Drug Listings and EMA’s XEVMPD, to the international ISO standard IDMP. The effort to implement systems to support a new standard is large and needs to begin soon.
    • Introduce how enterprise architecture standards can be leveraged to integrate multiple applications across multiple functions to meet IDMP needs. This session will discuss which Enterprise Architecture approach is best suited to integrate multiple systems together across multiple functions.

  • 1:30PM - 3:00PM

    Session 5 Track 3 - Identities & Signatures? What to Consider When Going Electronic


    Session Chair(s):

    • Betsy Fallen, RN
      United States

    When the current business practices evolve to make the most efficient use of the technology solutions, decisions need to be made. This session will focus on the assessment of how business processes currently use signatures and identity management and define opportunities to add efficiency and cost management through change management, alignment with industry standards, and enablement with industry shared infrastructure and adoption of technology.

  • 3:30PM - 5:00PM

    Session 6 Track 1 - IDMP Part 2: Are you ready for IDMP? The Business Perspective


    Session Chair(s):

    • Hans van Bruggen, MSc
      Director and Senior Regulatory Affairs Consultant
      eCTDconsultancy and Qdossier, Netherlands

    This session picks up from the previous IDMP background session and concentrates on integrating business processes and the challenges associated with it. This will be followed by a panel discussion. Topics include:
    • Provide a conceptual approach on how to get ready to meet IDMP requirements. Companies that had to comply with XEVMPD reporting requirements are well aware of the challenges collecting, curing and submitting required cross functional data. Even though IDMP implementation guidelines have not been published and software solutions don’t exist yet, preparations for IDMP should not be postponed.
    • Focus on understanding how cross-functional input is required to implement IDMP and discuss how to get ready for such an implementation, especially, around maintaining internal controlled vocabularies to support IDMP, RIM and beyond.• Provide insight to a company’s challenges for IDMP readiness.

  • 3:30PM - 5:00PM

    Session 6 Track 2 - eCTD v4 / RPS; Are you preparing for the transition to eCTD v4?


    Session Chair(s):

    • Mark A. Gray
      Director, Division of Data Management Services and Solutions, OBI, CDER
      FDA, United States

    eCTD v4, based on the Health Level Seven (HL7) Regulated Product Submission (RPS) exchange message, is more than just a different backbone. eCTD v4 includes more submission metadata, new life-cycle functionality, file reuse, and support for the exchange of information between regulatory authorities and sponsors. This session will cover the message functionality, technical aspects of the message, and organizational challenges in implementing eCTD v4. Listen to agency, sponsor, and vendor viewpoints that will enable attendees to understand the impact of the new standard, provide an update on the implementation process, and prepare for the transition to eCTD v4.

  • 3:30PM - 5:00PM

    Session 6 Track 3 - Successful Transformation from Start to Finish


    Session Chair(s):

    • Laura J. Sherman, MBA
      Training Partner, Clinical Business Operations
      Vertex Pharmaceuticals, Inc., United States

    This session will focus on the challenges and successes of organizational change management. Approaches, business process drivers, compliance, and user adoption will be discussed. Case studies to highlight an eTMF deployment regarding change management plan for implementing systems for TMF management, end-user friendly tool for real-time access to current Procedural document (SOPs/WIs) process steps improving compliance, and as more companies are converting to eCTD submissions, the efficiencies gained and cost effectiveness to outsource submission operations processes.

Day 3 Wednesday, Sep 24, 2014

  • 8:30AM - 10:00AM

    Session 7 Track 1 - Best Practices for eCTD Submission Development: Upstream and Downstream Activities that Impact the Submission Date


    Session Chair(s):

    • Emily Onkka
      Director, Regulatory Operations/Project Management
      GlobalSubmit, United States

    This session will explore ways to effectively lead an organization through generating submissions making a conscious effort to increase quality and reduce the total time needed from last document in to submission out the door. We will look at ways to influence cross-functional teams to ensure documents and deliverables are submission ready, and also learn how publishing teams effectively tackle large volumes.

  • 8:30AM - 10:00AM

    Session 7 Track 2 - Implementation of Regulatory Information Submission Standards (IRISS)


    Session Chair(s):

    • Lenore Palma
      Senior Principal Consultant
      Pharmaceutical eConsulting, United States

    Change continues to happen with the implementation of regulatory information submission standards. Are the processes at your company current regarding existing standards? Do you know what new standards are on the horizon? Have you begun to plan and make changes internally within your company to meets these new standards? Members of the IRISS Forum regularly discuss these types of questions. Using a global sounding board of expert advice and experience from peer-based IRISS topic groups, discussions focus on ways to achieve successful regulatory applications and proactively address implementation issues.

  • 8:30AM - 10:00AM

    Session 7 Track 3 - Working with Regional Affiliates to Achieve Compliance Globally


    Session Chair(s):

    • Stacy J. Tegan
      Senior Consulting, Strategic Consulting
      Accenture, United States

    Session 7 Track 3 - Working with Regional Affiliates to Achieve Compliance Globally

  • 10:30AM - 12:00PM

    Closing Plenary - "Ask the Regulators" Session


    Session Chair(s):

    • Gary M. Gensinger, MBA
      Deputy Director, Office of Business Informatics, CDER
      FDA, United States

    Closing Plenary - "Ask the Regulators" Session

  • 12:00PM - 12:15PM

    Closing Remarks

    Speaker(s):

    • Gary M. Gensinger, MBA
      Deputy Director, Office of Business Informatics, CDER
      FDA, United States
    • Betsy Fallen, RN
      United States
    • Christian A. Buckley, MBA, RAC
      Associate Director, Regulatory Operations
      Astellas Pharma Global Development, Inc., United States

Exhibits  

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

 

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

Booth Rental Fee Includes (per 10' 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
  • BIOVIA
  • Cardinal Health Regulatory Sciences
  • DIA
  • EMC Corporation
  • Ennov Solutions, Inc.
  • Exostar
  • EXTEDO
  • fme US LLC
  • GlobalSubmit
  • Infotehna, Inc.
  • LORENZ Life Science Group
  • MedXview, Inc.
  • Mission3
  • Montrium
  • PAREXEL
  • Pharmaceutical eConsulting
  • Phlexglobal
  • PleaseTech Ltd.
  • RegDocs365
  • Sciformix Corporation
  • Veeva

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

CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:

  • Member or Nonmember = $200
  • Government or Academia or Nonprofit (Member or Nonmember) = $100
  • Tutorial (if applicable) = $50

Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

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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