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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 

Tutorial: September 21, 2014
Regulatory Information Management (RIM)


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 the “Ask the Regulators Session” will 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

Learning Objectives 

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

  • Leverage technology and standards to optimize regulatory resources and business processes
  • Interpret global health authority regulations and guidances for systems and processes
  • Define the scope of IDMP and “Regulatory Information Management”
  • Construct eTMF capabilities to plan for clinical site inspection readiness
  • Recognize the shift in the impact of drug development toward industry and authority collaboration
  • Discuss challenges for ensuring compliance to meet regional requirements
  • Outline the importance of maximizing content reuse, metadata, aligning standards, and technology with the process
  • Describe organizational processes and governance to ensure integrity, quality, and security of records

Special Offers 

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 September 5, 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 

Continuing Education 

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

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 up to 1.9 CEUs for the program (.3 CEUs for the tutorial and 1.6 CEUs for the conference). Participants must attend the entire conference, (and tutorial, if applicable) 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:
• Project Management Certificate Program: 8 Elective Units • Regulatory Affairs Certificate Program: 10 Elective Units

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

Name Credit Type Max Credits CEU
Regulatory Information Management IACET 3.25 0.300
EDM and ERS 2014 IACET 15.75 1.600

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 program, sign in each day of the program, and complete the on-line 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 Wednesday, October 8, 2014.

Program Committee 

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Agenda  

Tutorials Sunday, Sep 21, 2014

  • 1:00PM - 4:30PM

    Room: Congressional Hall A

    Regulatory Information Management (RIM)

    Audience members will interact with tutorial leads to discuss the definition of “RIM,” data flows and integrations across RIM systems, current standards, important process considerations and roles and responsibilities across regulatory departments and systems.  The RIM Tutorial will provide attendees with an overview of the IT systems typically in use within the regulatory space. Attendees will also have a chance to discuss the future of RIM systems and standards. For more information please follow this link.

Day 1 Monday, Sep 22, 2014

  • 7:00AM - 8:00AM

    Registration and Continental Breakfast
  • 8:00AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • EDM and ERS 2014 Program Chair
      Gary M. Gensinger, MBA
      Senior Advisor, Office of New Drugs, CDER
      FDA, United States
    • EDM and ERS 2014 Program Chair
      Betsy Fallen, RN
      Principal
      BAFallen Consulting, LLC, United States
    • EDM and ERS 2014 Program Chair
      Christian A. Buckley, MBA, RAC
      Associate Director, Regulatory Affairs Submissions
      Astellas, United States
  • 8:30AM - 10:00AM

    Plenary Session 1 - FDA Update


    Session Chair(s):

    • Gary M. Gensinger, MBA
      Senior Advisor, Office of New Drugs, CDER
      FDA, United States

    Plenary Session 1 - FDA Update

    Speaker(s):

    • CDER eCTD Update
      Mark A. Gray
      Senior Project Manager, BSS, CBER
      FDA, United States
    • Moving Toward Required Study Data Standards, A Regulatory Update
      Ron Fitzmartin, PhD, MBA
      Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
      FDA, United States
    • Identification of Medicinal Products (IDMP): Update on Technical Specifications, Maintenance, and Implementation Activities
      Vada A. Perkins, BSN, MSc, RN
      Chief, Business Operations Staff, Office of Medical Products and Tobacco, CBER
      FDA, United States
    • CDER Direct: A New SPL Authoring Tool from FDA
      Paul M. Loebach
      Team Leader
      FDA Drug Registration & Listing, United States
  • 10:00AM - 10:30AM

    Refreshment Break/Networking/Exhibits
  • 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

    Speaker(s):

    • E-Review: Modernizing Canada's E-Regulatory System
      Irena Pastorekova
      Unit Head/e-Review, Office of Submissions and Intellectual Property (OSIP)
      Health Canada, Canada
    • An Essential Update on Agency Requirements and Expectations for Belgium
      Pieter Vankeerberghen
      Federal Agency for Medicines and Health Products, Belgium
  • 12:00PM - 1:30PM

    Lunch/Exhibits
  • 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 Affairs Submissions
      Astellas, 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.

    Speaker(s):

    • Repurposing eCTD for Multiple Regions
      Robert Connelly, MBA
      Product Manager - eSubmissions Software
      GlobalSubmit, United States
    • An Affiliate Submission Perspective from EU
      John-Paul Smith
      Associate Director Regulatory Operations
      Astellas Global Regulatory Affairs Europe, Netherlands
    • Beyond eCTD Consolidation Effort and Resubmission (CTD)
      Meredith K Sewell
      Director, Global Regulatory Publishing
      Allergan Inc., United States
  • 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.

    Speaker(s):

    • Enabling the New Drug Development Paradigm Through Collaboration and Interchange
      Paul Fenton, MBA, MS
      President & CEO
      Montrium, Canada
    • Internal Collaboration Activities within a Large, Departmentalized and Geographically Distributed Organization
      Francis Quinn
      Team Manager, US Publishing Team
      Pfizer, Inc., United States
    • Building a Pathway to the Global Marketplace through Collaboration and Partnership
      Colleen Marie Davenport, PhD
      Associate Director
      Accenture LLP, United States
  • 1:30PM - 3:00PM

    Session 1 Track 3 - Creating a Sustainable Global Clinical Research Collaborative Network


    Session Chair(s):

    • David Loose
      Vice President
      Essex Management, United States

    ACRES (Alliance for Clinical Research Excellence and Safety) is a non-profit collaboration of organizations including sponsors, CROs, government ministries and regulators, and service providers from across the clinical research enterprise to build a shared global system, recognizing the power of a shared vision and collaboration. Collaborators in the Foundation Initiatives are donating time, products, services and technologies to the many initiatives which will ultimately be available and benefit the clinical research community.

    The initiatives cover all domains of the clinical research endeavor such as quality, safety and pharmacovigilance, operations, site development, and information technology.

    This session will present insight into how this consortium is addressing the opportunities for clinical research enterprises to be more responsive to the challenges of financial and operational sustainability as well as continue to drive technological innovation.

    Speaker(s):

    • Alliance for Clinical Research Excellence and Safety (ACRES) An Overview
      David Loose
      Vice President
      Essex Management, United States
    • Developing Global Standards for Site Accreditation through ACRES
      Greg Koski, MD, PhD
      President and CEO, Co-Founder
      Alliance For Clinical Research Excellence and Safety (ACRES), United States
    • Developing the ACRES Global Technology Platform
      Tracy Blumenfeld, MBA
      President and CEO of RapidTrials
      RapidTrials, United States
  • 3:00PM - 3:30PM

    Refreshment Break/Networking/Exhibits
  • 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 Development Execution
      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 efficiently managing the content within eTMF/eDMS/eCTD systems effectively (enter data and upload documents once). 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.

    Speaker(s):

    • Demystifying eDMS, eTMF, and eCTD Integration
      Adair Turner
      Director, Regulatory and Clinical Operations
      Mission3, Inc., United States
    • Pfizer Case Study: Organizational Transformation through Content Management Optimization - Business Aspects
      Mary Emanoil, MS
      Director, Content Management Solutions Regulatory Information Management
      Pfizer Inc., United States
    • Technical Aspects
      David Andrew Clark
      Solution Engineer
      Pfizer, United States
    • Smarter Information Management
      Michael Rosenblatt
      Global Head, Regulatory Technology Solutions
      Roche, United States
  • 3:30PM - 5:00PM

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


    Session Chair(s):

    • Betsy Fallen, RN
      Principal
      BAFallen Consulting, LLC, 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

    Speaker(s):

    • Technology Review: How to Implement Paperless Clinical Trial Technology into Your Clinical Trial: Feasibility to Close Out
      Shannon Cooke, MS
      Project Manager
      TransPerfect Translations, United States
    • Update on eSource from a Regulators Perspective
      Ron Fitzmartin, PhD, MBA
      Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
      FDA, United States
    • Case Study: Practical Example of Running a Paperless Clinical Trial: Study Start up and eTMF Management
      James DeSanti
      President and CEO
      PharmaVigilant, United States
  • 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, 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.

    Speaker(s):

    • Benefits and Challenges of Establishing an eTMF in a Clinical Trial
      Rebecca Moraris
      Director, Clinical Management
      Pharma Start, United States
    • Using a Cloud-based eTMF to Improve Quality and Document Management Processes
      Jen Goldsmith
      Veeva Systems, United States
    • Incorporating Quality Reviews of the TMF into Everyday Work Processes: Basic Strategies to Implement Today!
      Lisa D. Mulcahy
      Owner, Principal Consultant
      Mulcahy Consulting, LLC, United States
  • 5:00PM - 6:00PM

    Networking Reception

Day 2 Tuesday, Sep 23, 2014

  • 7:30AM - 8:30AM

    Registration and Continental Breakfast
  • 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 Consultant
      Accenture Accelerated R&D Services, United States

    Mergers and acquisitions have become a way of life in the biopharmaceutical industry. After the initial dust has settled, the real transition begins. The path to the new "business as usual" is not always clear. The new organizations are challenged to select the better of the existing solutions, define a blended solution, or perhaps not integrate certain elements at all, maintaining redundant solutions. This session will look at three scenarios that while in distinct functional areas, provide practical considerations for approaching process integrations and system consolidations.

    Speaker(s):

    • Streamlining Global TMF Processes Through System Consolidation
      Vladimir Pyagay
      Clinical Solutions Manager
      Transperfect Translations, United States
    • Acquisition Management for Regulatory Operations
      Kevin Tompkins, MBA
      Associate Director, Global Submissions Management
      Teva Pharmaceuticals, Inc, United States
    • Post-Merger Process Diagnostics: Approach and Methodology Applied to the End-to-End CMC Change
      Tilman Burgert, PhD
      Accenture, Germany
  • 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.

    Speaker(s):

    • Case Study: Transitioning from Enterprise Applications to a Cloud Based Regulatory Information Management System (RIMS)
      Charles Deeck
      Senior Director, Regulatory Operations
      ARIAD Pharmaceutical, Inc., United States
    • Case Study: A Real-World Guide to eCTD in the Cloud
      McKenzie Ruecker
      Regulatory Operations Manager
      Mission3, Inc., United States
    • Case Study: Sponsor-CRO Collaboration Improvements
      Harry L. Graham
      Director, Global Regulatory Affairs Business Operations
      Covance, United States
  • 8:30AM - 10:00AM

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


    Session Chair(s):

    • Fran Ross
      Associate Director, Clinical and 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.

    Speaker(s):

    • TMF Reference Model and Oasis eTMF Standards: What’s Going On?
      Fran Ross
      Associate Director, Clinical and Regulatory Optimization
      Paragon Solutions, United States
    • Adapting the TMF Reference Model: Real World Advice
      Karen Roy, MPharm
      Global Business Development Director
      Phlexglobal Ltd, United Kingdom
    • Panelist
      Eric Rubinson
      Actavis, Inc, United States
  • 10:00AM - 10:30AM

    Refreshment Break/Networking/Exhibits
  • 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 Affairs Submissions
      Astellas, 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.

    Speaker(s):

    • Analysis and Decision Making for Establishing and Growing a Global Reg Ops Group
      Robert Connelly, MBA
      Product Manager - eSubmissions Software
      GlobalSubmit, United States
    • Global Regulatory Operations for a CRO – Opportunity in the Paradigm
      Eric W. Vestal, MA, MS, PMP
      Sr Director, Global Reg Ops Process & Technology; Reg Strategic Development
      Clinipace Worldwide, United States
    • A Sponsor’s Case Study on Efficient Regulatory Operations
      Muriel L. Spooner
      Senior Director Regulatory Affairs
      Celladon Corporation, United States
  • 10:30AM - 12:00PM

    Session 4 Track 2 - Why Would Anyone Adopt an eTMF?


    Session Chair(s):

    • Betsy Fallen, RN
      Principal
      BAFallen Consulting, LLC, 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, including a case study from the CRO’s perspective and the efficiencies an eTMF brings.

    Speaker(s):

    • Justifying EDMS for Clinical Trials Documents
      Michalle Adkins
      Manager, Life Sciences Consulting
      Emerson, United States
    • and
      Jacqueline White, PMP
      ISS Manager
      FHI 360, United States
    • Building a Business Case and Calculating ROI for an eTMF
      Michael Burton
      Director, CRO Alliances
      Veeva Systems, United States
    • eTMF: Case Study on Adoption from a CRO
      Jamie Marie Toth
      Director, Business Process & Solutions - eTMF, Clinical Development Services
      Covance Inc., 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
      Senior Director, Regulatory Services
      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.

    Speaker(s):

    • What’s Happening with the DIA EDM Harmonization Effort (Reference Models)?
      Steve Scribner
      Principal Consultant - Life Sciences
      EMC, United States
    • Leveraging the DIA EDM Reference Model to Speed Up the Deployment of a Regulatory EDMS: Experience, Challenges and Best Practices
      Olivier Paris
      Ennov, United States
    • Reconciling Clinical Operations and Regulatory Needs When Leveraging Industry Models
      Stefanie Wu
      Senior Business Analyst
      Montrium, Canada
  • 12:00PM - 1:30PM

    Lunch/Exhibits
  • 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 Affairs Submissions
      Astellas, 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.

    Speaker(s):

    • IDMP Overview and Data Model
      Joel Finkle
      Advisor, Emerging Practices
      CSC Life Sciences BPS, United States
    • An Architectural Approach to IDMP
      Venkatraman Balasubramanian, PhD, MBA
      President
      Cabeus, Inc., United States
  • 1:30PM - 3:00PM

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


    Session Chair(s):

    • Betsy Fallen, RN
      Principal
      BAFallen Consulting, LLC, 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.

    Speaker(s):

    • Standardized Digital Identities and eSubmissions: Is EMA Ahead of the Curve?
      Mollie Shields Uehing
      Safe-Biopharma Association, United States
    • Reducing Costs and Improving Information Control via a Shared Identity Infrastructure
      Tom Johnson
      Sr. Director/Product Manager Life Science Solutions
      Exostar, LLC, United States
    • Signature Practices and Technologies for TMF: An Industry Overview
      Kathie Clark
      Vice Presisdent, Product Management
      Wingspan Technology, United States
  • 3:00PM - 3:30PM

    Refreshment Break/Networking
  • 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.

    Speaker(s):

    • IDMP and Integrating Business Processes
      Hans van Bruggen, MSc
      Director and Senior Regulatory Affairs Consultant
      eCTDconsultancy and Qdossier, Netherlands
    • IDMP: A Sponsor’s Perspective
      Peter Terbeek
      Director, Regulatory Operations
      Astellas, United States
    • Panel discussion also includes:
      Joel Finkle
      Advisor, Emerging Practices
      CSC Life Sciences BPS, United States
    • Panel discussion also includes:
      Venkatraman Balasubramanian, PhD, MBA
      President
      Cabeus, Inc., United States
  • 3:30PM - 5:00PM

    Session 6 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.

    Speaker(s):

    • Publishing Regulatory Dossiers: Swimming Upstream to the Beginning
      Gina A Ross
      Director, Regulatory Submission Operations
      Cardinal Health Speciality Solutions, United States
    • IRISS GSO Surveys: Publishing Best Practices, Issues and Trends
      Marlene A. McCallum
      Senior Electronic Submissions Manager
      Spectrum Pharmaceuticals, Inc., United States
    • Preparing for the Module 1 Version 2.3 Update – Questions Addressed During IRISS Forum Topic Group Meetings
      Jennifer Ann LaFleur, MS
      Associate Director, Global Submission Management
      Boehringer Ingelheim Pharmaceuticals, Inc., United States
  • 3:30PM - 5:00PM

    Session 6 Track 3 - Successful Transformation from Start to Finish


    Session Chair(s):

    • Laura J. Sherman, MBA
      Training Partner, Clinical Development Execution
      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.

    Speaker(s):

    • An eTMF System Implementation is just one HUGE Change Management Plan
      Lisa D. Mulcahy
      Owner, Principal Consultant
      Mulcahy Consulting, LLC, United States
    • Leveraging Business Process Modeling for Improved Performance
      Eric Cardwell
      Director, Process Excellence Regulatory Affairs
      Abbvie, United States
    • Change Management – Outsourcing Regulatory Operations and eCTD
      Darryl Clarke
      Director, Regulatory Operations
      Sciformix, United States

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
      Senior Director, Regulatory Services
      GlobalSubmit, United States

    This session will provide an innovative look into eCTD navigation exploring strategic ways to focus submission teams on ways to improve quality and reduce time needed for publishing efforts at the end of the submission timeline. Focusing on large filings, this session will also provide a case study with lessons learned from a recently submitted global marketing application.

    Speaker(s):

    • Case Study: Preparing Your Largest eCTD NDA Submission
      Vishu Manegari, MBA, MS
      Associate Director
      Abbvie, United States
    • The Big Picture of eCTD Document Navigation: How Process, Perspective and People Make Measurable Impacts on Regulatory Subm
      Craig Gassman, MSc
      Sr. Associate II, Regulatory Operations
      Biogen Idec, Inc., United States
    • Presentation Title TBA
      Michelle Petty
      Associate Director, Regulatory Operations
      Biogen Idec, United States
    • The eCTD Red Zone: Managing Critical Path Activities to Accelerate the Submission Date
      Emily Onkka
      Senior Director, Regulatory Services
      GlobalSubmit, United States
  • 8:30AM - 10:00AM

    Session 7 Track 2 - eCTD v4 / RPS; Are you preparing for the transition to eCTD v4?


    Session Chair(s):

    • Mark A. Gray
      Senior Project Manager, BSS, CBER
      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.

    Speaker(s):

    • eCTD 4 and the FDA: The Not So Young and Restless
      Mark A. Gray
      Senior Project Manager, BSS, CBER
      FDA, United States
    • Planning for eCTD 4 Transition Success: Early Opportunities to Set the Course for eCTD 4 (Industry Perspective)
      Olga Alfieri, MBA, RAC
      Associate Director, Global Submissions Management (US)
      Eisai Product Creation Systems, United States
    • eCTD 4 and RPS - Scissors Cuts Paper Covers Rock
      Joel Finkle
      Advisor, Emerging Practices
      CSC Life Sciences BPS, United States
  • 8:30AM - 10:00AM

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


    Session Chair(s):

    • Stacy J. Tegan
      Senior Consultant
      Accenture Accelerated R&D Services, United States

    Supporting global compliance in today's increasingly complex environment is an arduous undertaking. Sponsors are challenged to seamlessly connect regional and central activities. This session will provide a look at current approaches to Regulatory Information Management (RIM) on a global scale. The latest industry study results will be revealed, showing how 40+ companies prioritize and invest in global collaboration, share vital information, and harness distributed regulatory knowledge. The inherent challenges will be discussed, along with strategies for effectively leverage innovative technologies in a holistic solution and practical learnings from a sponsor perspective.

    Speaker(s):

    • Global Regulatory Round II: Streamlining and Improving the Local, Regional, and Central Collaboration
      Steve Gens, MS
      Managing Partner
      Gens and Associates Inc., United States
    • How to Design a Global System That Will Be Used and Loved By Regional Affiliates
      John Lawrie
      Director, Product Strategy
      Veeva Systems, United States
    • Thinking Globally, Working Regionally: Opportunities and Challenges Working with Regional Affiliates in a Global World
      Carrie A. Mazzrillo, MBA
      Submissions Manager, Global Regulatory Affairs
      Eisai Inc., United States
  • 10:00AM - 10:30AM

    Refreshment Break/Networking
  • 10:30AM - 12:00PM

    Closing Plenary - "Ask the Regulators" Session


    Session Chair(s):

    • Gary M. Gensinger, MBA
      Senior Advisor, Office of New Drugs, CDER
      FDA, United States

    Closing Plenary - "Ask the Regulators" Session

    Speaker(s):

    • Panelist
      Mark A. Gray
      Senior Project Manager, BSS, CBER
      FDA, United States
    • Panelist
      Virginia Hussong
      Team Leader, Electronic Submission Support, OBI, CDER
      FDA, United States
    • Panelist
      Ron Fitzmartin, PhD, MBA
      Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
      FDA, United States
    • Additional FDA Speakers Invited
      United States
    • Panelist
      Pieter Vankeerberghen
      Federal Agency for Medicines and Health Products, Belgium
  • 12:00PM - 12:15PM

    Closing Remarks

    Speaker(s):

    • EDM and ERS 2014 Program Chair
      Gary M. Gensinger, MBA
      Senior Advisor, Office of New Drugs, CDER
      FDA, United States
    • EDM and ERS 2014 Program Chair
      Betsy Fallen, RN
      Principal
      BAFallen Consulting, LLC, United States
    • EDM and ERS 2014 Program Chair
      Christian A. Buckley, MBA, RAC
      Associate Director, Regulatory Affairs Submissions
      Astellas, 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

  • Accenture
  • ACUTA, LLC
  • Adlib
  • BIOVIA
  • Cardinal Health Regulatory Sciences
  • DIA
  • EMC Corporation
  • Ennov
  • ePharmaSolutions
  • Exostar LLC
  • EXTEDO
  • fme-US
  • GlobalSubmit
  • INFOTEHNA, a euroscript company
  • LORENZ Life Sciences Group
  • MedXview, Inc.
  • Mission3
  • Montrium
  • PAREXEL
  • Pharmaceutical eConsulting
  • Phlexglobal Inc.
  • PleaseTech Ltd.
  • Quintiles
  • RegDocs365
  • Sciformix

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$820.00
Member Government
$655.00
Member Industry
$1640.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1045.00
NonMember Government
$880.00
NonMember Industry
$1865.00
Registration Fees for Additional Offerings
Regulatory Information Management - Tutorial Rate
$405.00
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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