EDM and ERS 2014 unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials. Unless otherwise disclosed, the statements

DIA GLOBAL CENTER21 Dupont Circle, NW, Suite 300

Washington, DC 20036

WORLDWIDE OFFICESBasel, Switzerland | Beijing, China | Horsham, PA, USA

Mumbai, India | Tokyo, Japan

PROGRAM CO-CHAIRS:

Betsy FallenBAFallen Consulting, LLC

Christian A. Buckley, MBA, RAC Associate DirectorRegulatory Affairs SubmissionsAstellas

Gary M. Gensinger, MBASenior AdvisorOffice of Business InformaticsCDER, FDA

PROGRAM COMMITTEE:

Mark GrayDirectorDivision of Data Management Services and SolutionsCDER, FDA

Virginia HussongTeam LeaderElectronic Submission SupportOffice of Business InformaticsCDER, FDA

Daniel F. Orfe, MSPresident & CEORegulatory eSubmissions, LLC

Emily Onkka Senior DirectorRegulatory ServicesGlobalSubmit

Laura J. Sherman, MBATraining PartnerClinical Development ExecutionVertex Pharmaceuticals, Inc.

Stacy J. TeganSenior ConsultantAccenture Accelerated R&D Services

Hans Van BruggenSenior Regulatory Affairs ScientisteCTDconsultancy B.V.

OVERVIEW:With ever evolving regulations, both industry and agencies must continually reassess standards, processes, and technology to be operationally positioned to meet emerging requirements. EDM and ERS 2014 serves as a forum for the discussion of emerging standards and the processes for submission creation and maximum use of regulatory information.

EDM and ERS 2014 will feature collaborative sessions for you to share ideas and learn from experiences of colleagues, the opportunity to interact with speakers, agency personnel, and other participants in a dynamic and informative environment, as well as network with both the EDM and ERS audiences.

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

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

EDM and ERS 2014Tutorial: September 21 | Meeting: September 22-24Washington, DC

2

CONTINUING EDUCATION CREDITS

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 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.

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.

It is Drug Information Association 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. Faculty disclosures will be included in the course materials.

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.

Continuing Education Credit Allocation

• Tutorial – Regulatory Information Management: IACET .3 CEUs

• EDM and ERS 2014 (conference): IACET 1.6 CEUs

View DIA’s Grievance Policy at diahome.org/CE

DIA’S CERTIFICATE PROGRAM This program is part of DIA’s Certificate Program and is awarded the following:

• Clinical Research Certificate Program: 8 Elective Units

• Regulatory Affairs Certificate Program: 8 Elective Units

For more information go to diahome.org/certificateprograms

TO ACCESS PRESENTATIONS:• Visit diahome.org

• Login to My DIA

• Enter your User ID and Password

• View ‘My Presentation Downloads’

Please Note: DIA User ID and Password are needed to access presentations. If you have forgotten your DIA User ID and Password, or this is your first time logging into the DIA website, please use our Login Reminder

Follow #DIAEDM for real-time updates. | Connect with us! @DrugInfoAssn

http://www.diahome.org

http://diahome.org/CE

http://diahome.org/certificateprograms

http://diahome.org

3

SUNDAY, SEPTEMBER 21

12:00-5:00pm REGISTRATION

Please note that lunch is not served on tutorial day

1:00-4:30pm TUTORIAL

Tutorial – Regulatory Information Management (RIM) Tutorial

TuTorial insTrucTors:

Gloria McHugh Senior RIM ConsultantAccenture Accelerated R&D Services

Michael LisjakGlobal Regulatory Services LeadAccenture Accelerated R&D Services

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.

learning objecTives:

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

• Define the full scope of “Regulatory Information Management”

• Describe systems typically in use in the RIM space

• Explain high level RIM processes, data flow, standards

• Identify typical roles and responsibilities across regulatory and other functional area departments

• Discuss the future of RIM with respect to systems, process and standards


Save the Date eRegulatory and Intelligence Annual Conference

May 2015 | Philadelphia, PAdiahome.org/eRI

Call for Abstracts Opens September 24

Developideas, research, cures

Innovatewith other thought leaders

Advance world health for our generation and generations to come

Visit DIA Booth #403 for more information.

4

MONDAY, SEPTEMBER 22

7:00-8:00am REGISTRATION / CONTINENTAL BREAKFAST / EXHIBITS

8:00-8:30am WELCOME AND OPENING REMARKS

Program Chairs:




8:30-10:00am PLENARY SESSION 1

FDA Updatesession Chair

Gary M. GensingerSenior AdvisorOffice of Business InformaticsCDER, FDA

Panelists

CDER eCTD UpdateMark GrayDirectorDivision of Data Management Services and SolutionsOffice of Business InformaticsCDER, FDA

Moving Toward Required Study Data Standards, A Regulatory UpdateRon Fitzmartin, MBA, PhDSenior AdvisorData Standards ProgramOffice of Strategic ProgramsCDER, FDA

Identification of Medicinal Products (IDMP): Update on Technical Specifications, Maintenance, and Implementation ActivitiesFDA Speaker Invited

CDER Direct: A New SPL Authoring Tool from FDAFDA Speaker Invited

10:00-10:30am REFRESHMENT BREAK / NETWORKING / EXHIBITS

10:30am-12:00pm PLENARY SESSION 2

Other Regions Update session Chair

Hans van Bruggen, MScSenior Regulatory Affairs ScientisteCTDconsultancy B.V., The Netherlands

Panelists:

Irena PastorekovaUnit Head/e-ReviewOffice of Submissions and Intellectual Property (OSIP) Health Canada

Pieter Vankeerberghen, PhDFederal Agency for Medicines and Health Products (FAMHP)

12:00-1:30pm NETWORKING / EXHIBITS / LUNCH

5

1:30–3:00pm SESSION 1

TRACK 1

Leveraging the eCTD for Global Efficiency session Chair:


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.

Repurposing eCTD for Multiple Regions Robert Connelly, MBAProduct Manager – Electronic Submissions SoftwareGlobalSubmit

Leveraging Astellas EU eCTD dossier for submission to South Africa and Saudi ArabiaJohn-Paul SmithAssociate DirectorRegulatory OperationsAstellas Global Regulatory Affairs Europe

Case Studies: eCTD Consolidation & Resubmission Effort for EU and Using Functionality of the RIM System to Anticipate Questions during Review ProcessMeredith Sewell DirectorGlobal Regulatory PublishingAllergan

TRACK 2

Collaboration & Integration: Facilitating Internal - External Interactions and Processes session Chair:

Daniel F. Orfe, MSPresident Regulatory eSubmissions, LLC

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.

Enabling the New Drug Development Paradigm Through Collaboration and Interchange Paul Fenton, MBA,MSPresident & CEO Montrium

Internal Collaboration Activities within a Large, Departmentalized and Geographically Distributed OrganizationFran QuinnTeam ManagerUS Publishing TeamPfizer, Inc.

Building a Pathway to the Global Marketplace through Collaboration and PartnershipColleen M. DavenportAssociate DirectorRegulatory AffairsAccenture Accelerated R&D Services

TRACK 3

Creating a Sustainable Global Clinical Research Collaborative Network session Chair:

David Loose Vice President Essex Management

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.

Alliance for Clinical Research Excellence and Safety (ACRES) An Overview David Loose Vice President Essex Management David Loose Essex Management

Developing Global Standards for Site Accreditation through ACRESGreg Koski, PhD, MDPresident and CEOACRES

Developing the ACRES Global Technology Platform Tracy Blumenfeld, MBAPresident and CEO of RapidTrials and Co-Chair of the ACRES Site Accreditation Standards Initiative (SASI)


6

3:00-3:30pm REFRESHMENT BREAK / NETWORKING / EXHIBITS

3:30 – 5:00pm SESSION 2

TRACK 1

Organizational Transformation of Enterprise Systems and Standardssession Chair:


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.

Demystifying eDMS, eTMF, and eCTD Integration Adair Turner DirectorRegulatory and Clinical Operations Mission3, Inc.

Pfizer Case Study: Organizational Transformation through Content Management OptimizationBusiness asPeCts:

Mary Emanoil, MSDirector Content Management Solutions Regulatory Information ManagementPfizer Inc.

teChniCal asPeCts:

Dave ClarkSolution Engineer Pfizer Inc.

Smarter Information ManagementMichael RosenblattGlobal HeadRegulatory Technology SolutionsRoche

TRACK 2

Outlining the Pathway to a Paperless Trial session Chair:

Betsy Fallen BAFallen Consulting, LLC

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.

Technology Review: How to Implement Paperless Clinical Trial Technology into Your Clinical Trial: Feasibility to Close Out Shannon Cooke, MSProject ManagerTransperfect Translations

Update on eSource from a Regulators PerspectiveRon Fitzmartin, MBA, PhDSenior AdvisorData Standards ProgramOffice of Strategic ProgramsCDER, FDA

Case Study: Practical Example of Running a Paperless Clinical Trial: Study Start up and eTMF Management James DeSantiPresident and CEOPharmaVigilant

TRACK 3

Establishing Processes and Controls to Ensure an Inspection-Ready TMF Every Daysession Chair:

Lisa D. Mulcahy Owner and Principal Consultant Mulcahy Consulting LLC

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.

Benefits and Challenges of Establishing an eTMF in a Clinical TrialRebecca MorarisDirectorClinical ManagementPharma Start

Using a Cloud-based eTMF to Improve Quality and Document Management ProcessesJen Goldsmith Veeva Systems

Incorporating quality reviews of the TMF into everyday work processes: Basic strategies to implement today!Lisa D. Mulcahy Owner and Principal Consultant Mulcahy Consulting LLC

5:00-6:00pm NETWORKING RECEPTION

7

TUESDAY, SEPTEMBER 23

7:30-8:30am REGISTRATION / CONTINENTAL BREAKFAST / EXHIBITS

8:30–10:00am SESSION 3

TRACK 1

Managing the Practical Impacts of Mergers & Acquisitions: Approaches to Process and Systems Integration in Clinical, Regulatory, and Quality session Chair:


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.

Streamlining Global TMF Processes Through System Consolidation Vladimir PyagayClinical Solutions Manager TransPerfect

Acquisition Management for Regulatory Operations Kevin Tompkins, MBA Associate DirectorGlobal Submissions Management Teva Pharmaceuticals, Inc

Post-Merger Process Diagnostics: Approach and Methodology Applied to the End-to-End CMC Change Control ProcessTilman Burgert, PhDAccenture

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:

Daniel F. Orfe, MSPresident Regulatory eSubmissions, LLC

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.

Case Study: Transitioning from Enterprise Applications to a Cloud Based Regulatory Information Management System (RIMS) Charles DeeckSenior Director, Regulatory Operations ARIAD Pharmaceutical, Inc.

Case Study: A Real-World Guide to eCTD in the CloudMcKenzie Ruecker Regulatory Operations Manager Mission3, Inc.

Case Study: Sponsor-CRO Collaboration Improvements Harry GrahamDirectorGlobal Regulatory Affairs Business OperationsCovance

TRACK 3

e/TMF Reference Models: Interactive Colossussession Chair:

Fran Ross Associate DirectorClinical & Regulatory Optimization Paragon Solutions

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.

TMF Reference Model and Oasis eTMF Standards: What’s Going On?Fran Ross Associate DirectorClinical & Regulatory Optimization Paragon Solutions

Adapting the TMF Reference Model: Real World AdviceKaren RoyGlobal Business Development DirectorPhlexglobal Ltd

Open discussion and Q&A

10:00-10:30am REFRESHMENT BREAK / NETWORKING / EXHIBITS

8

10:30am-12:00pm SESSION 4

TRACK 1

Managing and Developing Regulatory Submission Operationssession Chair:


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.

Analysis and Decision Making for Establishing and Growing a Global Reg Ops group Robert Connelly, MBAProduct Manager – Electronic Submissions SoftwareGlobalSubmit

Global Regulatory Operations for a CRO – Opportunity in the ParadigmEric Vestal, MA, MS, EIT, PMPSenior Director, Global Reg Ops Process & TechnologyRegulatory Strategic Development Clinipace Worldwide

A Sponsor’s Case Study on Efficient Regulatory Operations Muriel Spooner, RACSenior Director Regulatory AffairsCelladon Corporation

TRACK 2

Why Would Anyone Adopt an eTMF?session Chair:


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.

Justifying EDMS for Clinical Trials Documents Michalle Adkins Emerson

Jacqueline WhiteIT Associate DirectorFHI 360

Building a business case and calculating ROI for an eTMF Michael Burton DirectorCRO AlliancesVeeva Systems

eTMF: Case Study on Adoption from a CROJamie Marie Toth, CPM DirectorBusiness Process & Solutions - eTMFClinical Development Services Covance Inc.

TRACK 3

Progression and Utilization of the DIA EDM Harmonization Effort (Reference Models)session Chair:


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.

What’s happening with the DIA EDM Harmonization Effort (Reference Models)? Steve ScribnerPrincipal ConsultantLife SciencesEMC

Leveraging the DIA EDM Reference Model to Speed Up the Deployment of a Regulatory EDMS: Experience, Challenges and Best PracticesOlivier ParisCEOEnnov

Reconciling Clinical Operations and Regulatory Needs When Leveraging Industry ModelsStefanie WuSenior Business AnalystMontrium

12:00-1:30pm NETWORKING / EXHIBITS / LUNCH


9

1:30-3:00pm SESSION 5

TRACK 1

IDMP Part 1: Are you ready for IDMP? The Technical Perspective session Chair:


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.

IDMP Overview and Data ModelJoel Finkle Senior StrategistRegulatory Informatics CSC Life Sciences

An Architectural Approach to IDMP Venkatraman (Bala) Balasubramanian, PhD PresidentCabeus, Inc.

TRACK 2

No Session in Track 2 at this time.

TRACK 3

Identities & Signatures? What to Consider When Going Electronic session Chair:


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.

Standardized Digital Identities and eSubmissions: Is EMA Ahead of the Curve? Mollie Shields-Uehling President & CEOSAFE-BioPharma

Reducing Costs and Improving Information Control via a Shared Identity InfrastructureTom JohnsonEXOSTAR, LLC

Signature Practices and Technologies for TMF: An Industry OverviewKathie Clark, MSVice PresidentProduct Management Wingspan

3:00-3:30pm REFRESHMENT BREAK / NETWORKING

Thank You to Our Media Partner!

10

3:30-5:00pm SESSION 6

TRACK 1

IDMP Part 2: Are you ready for IDMP? The Business Perspectivesession Chair:

Hans van Bruggen, MSc Director and Senior Regulatory Affairs ConsultanteCTDconsultancy 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

IDMP and Integrating Business ProcessesHans van BruggenSenior Regulatory Affairs ScientisteCTDconsultancy BV

IDMP: A Sponsor’s PerspectivePeter TerbeekDirectorRegulatory OperationsAstellas

Panel discussion also includes:Joel Finkle Senior StrategistRegulatory Informatics CSC Life Sciences

Venkatraman (Bala) Balasubramanian, PhD PresidentCabeus, Inc.

TRACK 2

Implementation of Regulatory Information Submission Standards (IRISS) session Chair:

Lenore Palma Senior Principal ConsultantPharmaceutical eConsulting

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.

Publishing Regulatory Dossiers – Swimming Upstream to the BeginningGina RossDirector, Regulatory Submission OperationsCardinal Health Specialty Solutions

IRISS GSO Surveys: Best Publishing Practices, Issues and TrendsMarlene McCallumSenior Electronic Submissions ManagerSpectrum Pharmaceuticals, Inc.

Preparing for the Module 1 Version 2.3 Update – Questions Addressed During IRISS Forum Topic Group MeetingsJennifer LaFleur, MSAssociate DirectorRegulatory OperationsGlobal Submission ManagementBoehringer-Ingelheim

TRACK 3

Successful Transformation from Start to Finishsession Chair:


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.

An eTMF System Implementation is just one HUGE Change Management Plan Lisa MulcahyOwner and Principal Consultant, Mulcahy Consulting LLC

Leveraging Business Process Modeling for Improved PerformanceEric CardwellDirector Process ExcellenceRegulatory AffairsAbbvie

Change Management – Outsourcing Regulatory Operations and eCTDDarryl ClarkeDirectorRegulatory OperationsSciformix


11

WEDNESDAY, SEPTEMBER 24

8:30–10:00am SESSION 7

TRACK 1

Best Practices for eCTD Submission Development: Upstream and Downstream Activities that Impact the Submission Datesession Chair:


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.

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.

Case Study: Preparing Your Largest eCTD NDA Submission Vishu Manegari, MBA, MS Associate Director Abbvie

The Big Picture of eCTD Document Navigation: How Process, Perspective and People Make Measurable Impacts on Regulatory Submissions Craig Gassman, MSc Senior Associate IIRegulatory Operations Biogen Idec, Inc.

Michelle PettyAssociate Director Regulatory OperationsBiogen Idec, Inc.

The eCTD Red Zone: Managing Critical Path Activities to Accelerate the Submission DateEmily Onkka Senior DirectorRegulatory ServicesGlobalSubmit

TRACK 2

eCTD v4 / RPS; Are you preparing for the transition to eCTD v4?session Chair:

Mark Gray DirectorDivision of Data Management Services and Solutions Office of Business InformaticsCDER, FDA

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.

eCTD 4 and the FDA: The Not So Young and RestlessMark Gray DirectorDivision of Data Management Services and Solutions Office of Business InformaticsCDER, FDA

Planning for eCTD 4 Transition Success: Early Opportunities to Set the Course for eCTD 4 (Industry Perspective) Olga Alfieri, MBA, RACAssociate DirectorGlobal Submissions Management (US)Eisai Product Creation Systems

eCTD 4 and RPS - Scissors Cuts Paper Covers Rock Joel Finkle Senior StrategistRegulatory Informatics CSC Life Sciences

TRACK 3

Working with Regional Affiliates to Achieve Compliance Globallysession Chair:


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.

Global Regulatory Round II: Streamlining and Improving the Local, Regional, and Central CollaborationSteve GensManaging PartnerGens and Associates

How to Design a Global System That Will Be Used and Loved By Regional AffiliatesJohn LawrieDirectorProduct StrategyVeeva Systems

Thinking Globally, Working Regionally: Opportunities and Challenges Working with Regional Affiliates in a Global WorldCarrie Mazzrillo, MBASubmissions ManagerGlobal Regulatory AffairsEiasi., United States

12

10:00–10:30am REFRESHMENT BREAK / NETWORKING / EXHIBITS

10:30am–12:00pm CLOSING PLENARY

“Ask The Regulators” Sessionsession Chair:


Panelists

Mark Gray DirectorDivision of Data Management Services and Solutions Office of Business InformaticsCDER, FDA

Virginia HussongTeam LeaderElectronic Submission SupportOffice of Business InformaticsCDER, FDA

Ron Fitzmartin, MBA, PhDSenior AdvisorData Standards ProgramOffice of Strategic ProgramsCDER, FDA

Additional FDA Speakers Invited

Pieter Vankeerberghen, PhDFederal Agency for Medicines and Health Products (FAMHP)

12:00-12:15pm CLOSING REMARKS

Program Chairs:




12:15pm MEETING ADJOURNED

No Lunch Served