Drug Information Association - eRegulatory and …...in regulatory submissions and electronic document management, respectively. As the eRegulatory and intelligence space emerges,

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OVERVIEW

EDM and ERS is combining with RIM in 2015 for the eRegulatory and Intelligence Annual Conference. In recent years, industry as a whole has been converging towards looking at regulatory as an end-to-end process. Document management, publishing and technical regulatory requirements are all subsets of regulatory information management at its broadest definition.

Sessions are separated into four tracks. The RIM business-focused track provides the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact as well as gain a greater understanding of key issues shaping the global regulatory environment. The technology track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned. The traditional ERS and EDM tracks will focus on emerging trends and best practices in regulatory submissions and electronic document management, respectively.

As the eRegulatory and intelligence space emerges, it is critical to break down silos for end to end processing of regulatory information as it relates to EDM and ERS. Lessons learned from recent mergers have highlighted the importance of regulatory intelligence as well as efficient systems and processes. Many people and companies define RIM differently but maximizing access to information is critical to gain efficiencies and remain competitive. This year’s new combined program aims to incorporate all relevant topics from the previous separate conferences without sacrificing focus.

LEARNING OBJECTIVES

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

• Describe organizational processes and governance to ensure integrity, quality, and security of records

• Discuss how to break down silos for end to end processing of regulatory information as it relates to EDM and ERS

• Envision the scope and future of IDMP with respect to systems, process, standards and master data

• Discuss organizational implications related to increasing electronic interactions with stakeholders

• Explain ways to implement processes to improve communication of regulatory expectations and communications

• Interpret global health authority regulations and guidance’s for systems and processes

• Describe how to map eTMF capabilities to support clinical site inspections

• Identify techniques to create efficiencies in the overall end to end process of document and submission management

eRegulatory and Intelligence Annual ConferenceTutorial: May 11 (AM) | Meeting: May 11–13

Sheraton Philadelphia Downtown Hotel | Philadelphia, PA

As of May 7, 2015

This program was developed in collaboration with the Document and Records Management and Electronic Regulatory Submissions Communities.

PROGRAM CO-CHAIRS:

Christian A. Buckley, MBA, RAC Associate DirectorRegulatory AffairsAstellas

Sarah Powell, RAC PresidentPowell Regulatory Service

PROGRAM COMMITTEE:

Kimberly Belsky, MS Executive DirectorRegulatory Affairs, AdPromo, Labeling and PolicyValeant Pharmaceuticals

Jake DoranIT DirectorGlobal Regulatory AffairsJanssen Pharmaceuticals, a division of Johnson & Johnson

Betsy Fallen, RN PrincipalBAFallen Consulting, LLC

Mark A. Gray Senior Project ManagerBioinformatics Support Staff (BSS)CBER, FDA

Virginia HussongActing DirectorDivision of Data Management Services & Solutions OBI, OSPCDER, FDA

Dominique E. Lagrave, PharmD, MSc Director GRAAS OperationsGlobal Regulatory WritingAmgen, Inc.

Emily OnkkaSenior DirectorRegulatory AffairsPfenex Inc.

Daniel F. Orfe, MSDirector of Regulatory Operations & Information ManagementRadius Health, Inc.

Laura J. Sherman, MBATraining Partner, Clinical Business OperationsVertex Pharmaceuticals, Inc.

Stacy J. TeganSenior ConsultantAccenture Accelerated R&D Services

Hans van Bruggen, MSc.Director and Senior Regulatory Affairs ConsultanteCTDconsultancy and Qdossier

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CONTINUING EDUCATION CREDITS

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

As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer up to 1.9 CEUs (.3 CEUs for the tutorial and 1.6 CEUs for the conference) for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

Continuing education credit is not available for the virtual event.

If you would like to receive a statement of credit, you must attend the program, and tutorial, if applicable, sign in at the DIA registration desk each day of the meeting, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.DIAGlobal.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, May 27, 2015.

It is the DIA’s 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.

CONTINUING EDUCATION CREDIT ALLOCATION

• Tutorial – IDMP? What Is That and How Do I Get Started?: IACET .3 CEUs

• Conference – eRegulatory and Intelligence Annual Conference: IACET 1.6 CEUs

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DIA’S CERTIFICATE PROGRAM 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: 8 Elective Unit

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

TO ACCESS PRESENTATIONS:• Visit DIAGlobal.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

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MONDAY, MAY 11

7:30-8:30am REGISTRATION AND CONTINENTAL BREAKFAST

8:30am-12:00pm TUTORIAL #1 – IDMP? WHAT IS THAT AND HOW DO I GET STARTED?

TUTORIAL INSTRUCTORS:

Amanda Keller, MAManager Regulatory Technology ConsultingAccenture Accelerated R&D Services

Leah KleyleinRegulatory Product StrategistAccenture Accelerated R&D Services

Michiel StamRegulatory Operations ConsultanteCTD Consultancy

The tutorial will start with an overview on IDMP and its impact on industry. You will interact with other attendees and tutorial leads to discuss the important steps organizations should consider to achieve the correct positioning and ultimately readiness for IDMP. The IDMP tutorial will provide you with an overview of recommended steps to determine where in your organization the required data lives today, develop a common language and understanding of the data, and define the processes and systems that will permit its aggregation. You will be encouraged to apply the concepts to your organization through small group activities focused on:

• Identifying owners and sources of IDMP product data

• Assessing the quality and potential issues with source data

Practical experience of consolidation and transformation of multiple data sources to XEVMPD output, challenges with sources of data, and managing global and local terminology will be shared.

You will also have a chance to discuss the future of software solutions for actually submitting IDMP data to the regulatory authorities.

LEARNING OBJECTIVES:

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

• Explain the scope of “IDMP” including steps to consider in preparing for IDMP

• Identify an action plan to engage affected stakeholders and to evaluate the current state of affected data and processes

• Envision the future of IDMP with respect to systems, process and standards

TARGET AUDIENCE:

This tutorial is designed for individuals in regulatory affairs, regulatory operations, supporting IT and other related functions who are tasked with assessing their organizations IDMP readiness. Anyone looking for an introduction to the impact of IDMP on their organization will benefit from this tutorial.

12:00-1:00pm LUNCH BREAK

**Please note: Lunch is not provided by DIA.

1:00-1:30pm WELCOME AND OPENING REMARKS

PROGRAM CO-CHAIRS:



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1:30-3:00pm PLENARY SESSION 1

FDA Update

SESSION CHAIR:

Mark A. GraySenior Project ManagerBioinformatics Support Staff (BSS)CBER, FDA

PANELISTS:

Virginia HussongActing DirectorDivision of Data Management Services & Solutions OBI, OSPCDER, FDA

Roberta Szydlo, RPh, MBA, RACSenior Regulatory Review OfficerCDER, FDA

Norman Schmuff, PhDAssociate DirectorOPQ/OPFCDER, FDA

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

3:30-5:00pm PLENARY SESSION 2

Other Regions Update

SESSION CHAIR:

Hans van Bruggen, MScDirector and Senior Regulatory Affairs ConsultanteCTDconsultancy and Qdossier

SPEAKERS:

Hans van Bruggen, MScDirector and Senior Regulatory Affairs ConsultanteCTDconsultancy and Qdossier

Harald von AschenEnterprise ArchitectFederal Institute for Drugs and Medical DevicesBfArM

5:00-6:30pm NETWORKING RECEPTION / EXHIBITS

Enjoy light hors d’oeuvres with old friends and new colleagues at the networking reception. All exhibitor booths will be open giving you the chance to work on your exhibitor passport, hear about their products and services, and make new connections.

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TUESDAY, MAY 12

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

8:30-10:00am SESSION 1

TRACK 1 – RIM BUSINESS

Actionable Regulatory Intelligence – Avoiding the “Groundhog Day” Syndrome

SESSION CHAIR:

Kimberly Belsky, MS Executive DirectorRegulatory Affairs, AdPromo, Labeling and PolicyValeant Pharmaceuticals

In a global regulatory environment, requirements and information you need to meet and exceed the expectations of your company and health authorities are evolving constantly, even as you sleep. This session will demonstrate how regulatory intelligence allows the regulatory professional to harness information and advance time to market.

Show Leadership with your Newsletter – and How to Impress your Regulators

Rasmus Engelbrecht, MS Senior Regulatory Intelligence Manager Novo Nordisk A/S

Leveraging Analytics Driven Regulatory Intelligence for Proactive Compliance & Reduce Time to Market

Manish Khatri, MS Senior ConsultantBusiness Strategy, Life Sciences Cognizant Business Consulting

Business Case for Managing Global Regulatory Requirements and Intelligence

Venkatraman (Bala) Balasubramanian, PhD PresidentCabeus, Inc.

TRACK 2 - ERS

Preparing for the New Module 1 (3.3 Format)

SESSION CHAIR: Christian A. Buckley, MBA, RAC Associate DirectorRegulatory Affairs Astellas

This session will outline and explore the new Module 1 specifications. The FDA presentation plans to provide an update on current timelines and expectations. Technical details on mandatory information for promotional materials and complexities that users will need to manage when cross-referencing other applications will also be discussed. Finally, a sponsor’s perspective will outline how to prepare for new business processes and leverage technology.

Using the New FDA Module 1

Robert Connelly, MBA Product ManagereSubmissions Software GlobalSubmit

Lessons Learned Creating Sequences in the New FDA Module 1

Michael A. FrantzManagerRegulatory OperationsDyax Corp.

FDA’s Module 1 Update: From Ideas to Implementation

Jared C. Lantzy, PMP Operations Research Analyst Office of Business Informatics (OBI) CDER, FDA

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TRACK 3 – EDM

eTMF & eSignatures: Issued, Applied, Inspected

SESSION CHAIR:

Lisa D. MulcahyOwner, Principal ConsultantMulcahy Consulting, LLC

As healthcare moves away from paper to a broader adoption of digitized documents, a key component to enabling that adoption is a digital signature. A case study will be presented from the digital credential provider and the medical practice that underwent an assessment, selection and adoption of the technology. The attendee will learn how the Sarah Canon Research Institute identified the business needs, completed the supplier evaluations, and choose the appropriate vendor for their needs. To complement the adoption of the digital credential, a former inspector will share his GCP experience with TMF and electronic documents while at the FDA and recent opportunities advising Sponsors and CROs.

Mike RashtiConsultant BIMO Auditor and Trainer, LLC

Peyton HaleDirector Research ApplicationsSarah Cannon Research Institute

John B. HarrisSenior Vice PresidentProduct ManagementSIGNiX

TRACK 4 – RIM TECHNOLOGY

RIM in the Cloud - Benefits & Challenges

SESSION CHAIR:

Jake Doran IT DirectorGlobal Regulatory AffairsJanssen Pharmaceuticals, a division of Johnson & Johnson

Attendees will be informed of the various strategies about implementing a multi-vendor cloud based RIM strategy. As cloud solutions are relatively new in the regulatory space, this will give attendees an opportunity to walk away with a clear understanding of the benefits and challenges associated with this approach. The session will focus on specifics of implementing a validated regulatory environment using cloud capabilities, including the “why” and “how”. The session will then transition into a panel discussion with industry representatives sharing pros and cons of the cloud approach, as well as real world examples and experiences. Conclusion will be an active Q&A session between presenters and the audience.

Implementing a Multi-Vendor Cloud Based RIM Strategy

Keith ParentCEOCourt Square Group

PANELISTS:

Antoinette M. AzevedoCo-FounderRegDoc365, LLCPresident and Chief Executive Officer E-submissionssolutions.Com

James Averback, MSPresidentLife Science Integration Partners

E. Mitchell Seymour, PhD, RACPrincipal/FounderR&D Advisors LLC LeadRegulatory OperationsUniversity of Michigan Institute for Clinical and Health Research

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






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10:30am–12:00pm SESSION 2


Organizational Implications to the Changing RIM Environment

SESSION CHAIR:


This session will explore how the RIM environment is affecting the way regulatory teams are established and operating. The new roles created to support the evolving environment, options for organizational structures, and changes in technology that supports the new paradigm will be examined.

Regulatory Operations 2.0 and the Rise of the Regulatory/Systems Centaur

Joseph R. BaldariManagerGlobal Regulatory SystemsCSL Behring

Design Considerations for Diverse Regulatory Organizations

Robin A. KeenVice PresidentEnterprise Regulatory Operations ExcellenceJohnson & Johnson

Regulatory Information and Systems: The View from the Affiliate

Greg BrolundConsultantChicopee Falls Consulting, LLC

TRACK 2 - ERS

Best Practices and Tactics for High Quality and High Efficiency eCTD Submissions: Document Authoring, Navigation and Content Reuse for Multi-regional Applications

SESSION CHAIR:


Case studies and lessons learned will be shared to demonstrate the value that navigation adds to electronic submissions and points to consider when content is to be repurposed across regions. This session will provide thoughtful strategies to maximize reuse and compliance of standards across regions.

Strategic eCTD Hyperlinking: It’s Time to Provide Purposeful Navigation to Facilitate a Streamlined Submission Review

Craig Gassman, MSManagerRegulatory OperationsKaryopharm Therapeutics

Medical Writing Style Conventions for Optimal Hyperlink Presentation and Navigation Value

Anna Marie RasmussenSenior DirectorMedical WritingReceptos, Inc.

Building Efficiencies in a Global Electronic Environment: A Case Study

Linda Chong, MBAAssociate ManagerGlobal Regulatory OperationsCelgene Corporation






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TRACK 3 – EDM

Reducing Duplicate Systems, Updating Outdated Systems...Sounds Great, but What About Migrating All That Data?

SESSION CHAIR:


Technology solutions are only as good as the data existing within. This session will explore how to migrate documents and data from legacy systems in a way that minimizes the pain and strain on the organization, and puts the business needs first. Case studies will provide practical knowledge on topics such as constructing a thorough migration plan, dealing with legacy metadata standards, planning for service interruptions, and common technical issues. Tips for creating and executing a communication plan to keep the user community informed will also be shared.

Leading Practices for Regulated Content Migrations

Dan Wheeler, MBAAmericas Life Sciences Practice LeaderEMC Corporation

Planning for a Successful Migration


Migration Case Studies from a Sponsor Perspective

Candace RiederDevelopment Operations Senior ManagerRecords & Information ManagementAmgen, Inc.


Master Data Management, IDMP and RIM – How Can They Relate?

SESSION CHAIR:

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

Companies are preparing for IDMP but it is not just an issue of assembling data for regulatory compliance purposes. A strategic approach should be considered, leveraging RIM capabilities and capitalizing on an opportunity to implement or expand Master Data Management across multiple functions thereby increasing efficiencies and end-to-end visibility of information. This session will explore the relationship among IDMP, MDM and RIM and depict options to utilize the chances of IDMP within your company.

IDMP: A Threat to Your Compliance or a Chance for Regulatory Operational Excellence?

Timm Pauli, MScHead of Regulatory OperationsPharmaLex GmbH

IDMP: A Key Business Driver for Master Data Management in Life Sciences

Venkatraman (Bala) Balasubramanian, MBA, PhDPresidentCabeus, Inc.

Sponsor Perspective: Using IDMP as a Driver for Master Data Management

Peter Terbeek, MBADirectorRegulatory Affairs Astellas

12:00-1:30pm LUNCH / EXHIBITS






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1:30–3:00pm SESSION 3


Communication Challenges in Changing Regulatory Environments

SESSION CHAIR:

Brooke Casselberry, MSDirector SolutionsRegulatory SMENextdocs Corporation

As organizations grow and product lines expand, information becomes increasingly difficult to track and manage. This session will identify challenges of tracking and managing communications and present a case study on what two companies have done to overcome these challenges.

Challenges in Communicating RI: Creating a New Tool for a Global Organization

Emily HuddleRegulatory Intelligence ExecutiveGlaxoSmithKline

Regulatory Intelligence – From Limitless Information to Targeted Messages

Bonnie Safyurtlu, MS, RACDirectorGlobal Regulatory AffairsAllergan, Inc.

Digging into Your Internal Regulatory Intelligence Goldmine


TRACK 2 - ERS

Leveraging Submission, Document & Data Standards for Beneficial Organizational Impact

SESSION CHAIR:

Daniel F. Orfe, MS Director of Regulatory Operations & Information ManagementRadius Health, Inc.

This session will provide an exploration of how standards have been and can be exploited to facilitate internal and external collaboration activities, document management and submission production. Standards exist to provide consistent formatting and mechanisms to generate, gather, archive and deliver documentation, data and submissions to health authorities. These same standards can be adopted and expanded upon to benefit an organizations efficiencies, capacity and capabilities.

Stretching Standards to Cover eCTD InterOperability; Standard Gaps for InterOperability

Donald Palmer, MA DirectorProduct Strategy and Regulatory InformaticsAcuta LLC

Changing the Drug Development Landscape: Impact of Electronic Data Standards on FDA Submissions and Preclinical Data Analysis

Laura Sue Kaufman, PhD, DABTDirectorPreclinical AffairsPDS Preclinical Data Systems

Facilitating Content Exchange Through the TMF Reference Model - Presentation of the New Initiative for an eTMF Exchange Standard from the TMF Reference Model

Paul Fenton, MBA, MSPresident & CEOMontrium

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TRACK 3 – EDM

How Audit and Inspection Ready is Your Organization?

SESSION CHAIR:

Laura Sherman, MBAClinical Training PartnerVertex Pharmaceuticals Inc.

Sharing practical approaches and challenges on being audit and inspection ready will be the focus of discussion. The Clinical Trial Regulation states that the TMF should be readily available and directly accessible. From a system’s perspective, the ultimate goal would be to enable an inspector access to browse through all eTMF content easily, with minimum training and single point of entry even with the documentation stored in multiple electronic repositories and archives. Mapping the TMF and all related systems in a controlled and documented methodology approach can help facilitate improved inspection readiness and decision making. In general, what is your organizational strategy and inspection readiness plan for records management and personnel? Compliance training must go beyond checking the box to read/sign-off on procedural documents for compliance qualification. Organizational development is critical for sustainability and having a transformational proactive approach for staff training and maximizing engagement. From a QA Auditor’s perspective on general records inspections, coaching users on different regulatory agency approaches to audits, creating checklists, dashboards, organizing mock inspections and incorporating lessons learned.

TMF Case Study for Being Inspection Ready

Dorte Frejwald ChristiansenAdvanced Business ConsultantNNIT A/S

Creating Business Impact From Your Compliance Training

Sheri WinterDirectorClient DevelopmentCaveo Learning

Inspection Readiness from a GCP QA Auditor’s Perspective

Rajeev KhajuriaQuality Assurance Regulatory Affairs Practice DirectorIntegrated Resources Inc.


IDMP Implementation – Opportunities and Challenges

SESSION CHAIR:

Hans van Bruggen, MSc Director and Senior Regulatory Affairs ConsultanteCTDconsultancy and Qdossier

Life Sciences companies will be forced to comply with IDMP soon. Though it will be a challenge, it is the ideal opportunity to finally realize the cross-disciplinary integration (read cross budget) of processes and systems. When well implemented, the companies establish a reliable single source of truth, leading to increased transparency and efficiency.

In this session, we will address key aspects of IDMP implementation guidelines and how to maintain reliable data to support IDMP.

Overview of IDMP Implementation Guidelines

Lise R. StevensProject ManagerBioinformatics Support Staff (BSS)CBER/FDA

Overview of Impacted Business Processes and Data Management


Impacts to Systems and Tools – A Conceptual Overview

Christian KaasDirector DevelopmentLORENZ Archiv-Systeme GmbH

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






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3:30–5:00pm SESSION 4


RIM as an Enabler for Interoperability and Transparency: Current Achievements in Industry and Agencies

SESSION CHAIR:


This session will outline industry, health agency and vendor perspectives on RIM enabling operational efficiency. Presenters will demonstrate real life challenges and pragmatic solutions they have already applied to their environments to bring about interoperability and transparency as opposed to a scratch-all and instate a “RIM solution” undertaking.

Industry Perspective

Teresa MartinsDirectorGlobal Submission ManagementBayer Healthcare Pharmaceuticals Inc.

Interoperability Between Existing Regulatory Systems: Conceptual Challenges and Practical Solutions

Akira Yamaguchi, MBAVice PresidentProduct MarketingLORENZ International

Interoperability of Systems Within the Germany Agency

Harald von AschenEnterprise ArchitectFederal Institute for Drugs and Medical Devices (BfArM)

TRACK 2 - ERS

eSubmission Collaboration and Considerations for Cloud Solutions

SESSION CHAIR:


eSubmissions is no longer limited to big pharma. It is also no longer limited to tool installations within a single location. Cloud solutions can be distinguished in various forms and each of them offer us to collaborate across locations/regions and companies. The presenters will share their experiences with and knowledge of cloud solutions within and across companies.

Soup to Nuts: A Recipe for eCTD Success and Cloud

Antoinette M. AzevedoCo-FounderRegDoc365, LLC

Working in the Cloud: Leveraging a Cloud for DMS and Regulatory Submissions

Carrie A. Mazzrillo, MBASubmissions ManagerGlobal Regulatory AffairsEisai Inc.

Conducting Great Regulatory Operations in a Small Company Environment – Lessons Learned

Thomas J. NotoSenior Director Regulatory Operations Lexicon Pharmaceuticals

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Deliver Relevant and Timely Content that Will Benefit Your Customers and Prospects, While Generating Qualified Leads for your Organization.

DIA’s Solution Provider Webinars offer you an exciting new way to hit your target audience right where they live and work. You deliver relevant and timely content that will benefit your customers and prospects, while generating qualified leads for your organization, and DIA will promote, record, and host the webinar.

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TRACK 3 – EDM

The Intersection of Clinical and Regulatory: Document Management Meets Submission Management

SESSION CHAIR:


From the adoption of the TMF Reference Model for managing Essential Documents to the EDM Reference Model for managing documents intended for submission in support of the implementation of the CTD, there is the potential for inefficiencies in the overall end to end process. We will examine how the requirements in each area may impact other areas and explore efficiencies to support each.

What To Do with the EDM Reference Model, When You Think In Terms of the CTD?

Lalana Dararutana, MSSenior ConsultantVeeva Systems, Inc.

From Archiving to Compliance Utilizing Business Process to Create Regulatory Assets

Michelle CharlesAssociate DirectorRegulatory AffairsMerck & Co., Inc.

Opportunities for Efficiency Gains in the Post-Submission Application Process: Submission Archiving and Management

Jessica LeFur Systems EngineerAmericas Life SciencesEMC CorporationEnterprise Content Division


IDMP: Hit the Road Beyond Compliance

SESSION CHAIR:


Both industry and agencies are on the challenging road towards IDMP compliance. Upon establishing IDMP, company employees will be rewarded with a comprehensive, structured data model containing multi-disciplinary information. Bringing this information together offers increased transparency and control over data quality and strengthens communication and collaboration between business units. This session will help you navigating towards the destination IDMP and provides a use case associated with product release as an example of one the many benefits IDMP can bring.

IDMP: European Requirements - Will We Get it Right?

Joel FinkleAdvisorEmerging PracticesCSC Life Sciences BPS

Five Phases Towards ISO IDMP compliance - Practical Experiences and Challenges in Getting in Compliance

Rune BergendorffGlobal IDMP Service LeadNNIT

Using the IDMP standards to Facilitate Medicinal Product Batch Release (via email)

Bill MandarinoAssociate DirectorProduct License Knowledge ManagementUCB, Inc.

6:00pm DINNER ON THE TOWN

Network with your colleagues at your choice of three restaurants! DIA has made dinner reservations, and all you need to do is pick a restaurant and enjoy a night of fun, networking, and great conversation!

Meet in the lobby at 6:00PM and reservations are at 6:30PM. Sign-up sheets will be available onsite; dinner cost is on your own.

Visit the DIA registration desk to sign-up for Dinner on the Town!

LaScala’s (Old City): http://www.lascalasphilly.com/about.html Italian restaurant; close to Old City near Independence Hall and the Liberty Bell

Fare (Fairmont): http://farerestaurant.com/ Farm fresh and gluten free in Fairmont area

Devon Seafood Grill (Rittenhouse): http://www.devonseafood.com/home.aspx?location_id=96Upscale seafood/steaks in famous Rittenhouse square






http://www.lascalasphilly.com/about.html

http://farerestaurant.com/

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WEDNESDAY, MAY 13

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

8:30–10:00am SESSION 5


Labeling, Listing, and Compliance – Getting and Keeping Your Drug Product on the Market

SESSION CHAIR:

Kimberly Belsky, MS Executive Director Regulatory Affairs, AdPromo, Labeling and Policy Valeant Pharmaceuticals

Strategic considerations for submission and approval of prescription drug labeling, drug and establishment listings, and the resources you need to get and keep your product in distribution will be explored.

Prescription Drug Labeling: Implementation of FDA’s New Guidances and Safety Initiatives in Label and Artwork Development (61465)

Christine FergusonGlobal Labeling Manager-Global Labeling (US HUB)Global Regulatory Affairs, GROCBayer HealthCare

CDER Direct

Paul M. LoebachTeam LeaderDrug Registration and Listing ProgramOCCDER/FDA

SPL Essentials to Bring Your Product to Patients

Mary Beth Wilusz Labeling Operations and ComplianceWorldwide Product LabelingMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

TRACK 2 - ERS

A Review of Changes GDUFA Has Brought To the ANDA Process and The Regulatory Business Impact

SESSION CHAIR:


The Generic Drug User Fee Amendments of 2012 (GDUFA) is a historic first for user fees to be paid by industry to FDA to ensure the timely review of applications for generic drugs. The fees supplement the costs of reviewing applications through allocation of additional resources for application review, facility inspection, and reduction of the backlog of pending applications. Implementing GDUFA requirements has brought night-and-day changes to the regulatory environment among sponsors that generate ANDA submissions. This session will provide case studies from large, mid, and small size bio-pharmaceutical companies that develop human generic drugs.

Impact of GDUFA on Electronic Publishing in a Large Generics Organization

Jennifer CostelloManagerGlobal Regulatory OperationsTeva Pharmaceuticals

GDUFA: 2.5 years later...Impact & Importance

Georgia HizonManagerRegulatory PublicationsAPP Pharmaceuticals / Fresenius Kabi USA

Regulatory Operations Crash Course in GDUFA







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TRACK 3 – EDM

Organization Culture Consideration When Adopting Submission & Document Management Systems

SESSION CHAIR:


This session will describe solutions for optimizing regulatory information management and document management systems to serve multiple purposes, including regulatory and scientific needs while taking into consideration the intrinsic culture of an organization. The technology is not as crucial as the people who will use it and the business process supporting it. Expecting technology to tackle all challenges is a mistake. Technology can potentially improve processes but needs to integrate as “painlessly” as possible within the organizations culture. An exploration of the various controversies and best practices will be provided.

Expanding the Use of a Regulatory Submission Management System for Nonclinical Records Management

Cindy ChiuAssociate Director, Regulatory AffairsMerck & Co., Inc.

Holistic Regulatory Information, Document and Process Management Solution: How to Get There

Agniezska Wanat Regulatory Affairs Director EMEA ICN products Valeant

Romuald Braun Vice President Strategy Life SciencesInfotehna Group


IDMP Implementation – Where is the Correct Data?

SESSION CHAIR:


Over the years companies have grown. During the growth, disciplines within companies diversified and took ownership of a smaller part of the company’s knowledge and data. The disciplines acknowledged the sharing of parts of each other’s information which led to duplication of information. The maintenance of duplicate data is a risk. The question is how do we know where to find reliable data? Suggested solutions will be discussed.

Data’s Revenge or Why RIM’s Emerging Dossier Concept Should Be Served From a ‘Single Place of Truth’

Olaf Schoepke, PhDDirector of Strategic DevelopmentSamarind Ltd.

Developing RIM Solution to Access Accurate, Streamlined and Real Time Regulatory Information for Pharma/Biopharma Companies

Abhishek Harde, MBA, MPharm, RAC Cognizant Technology SolutionsCorporation

Source Data: The Future of Regulatory Affairs


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






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10:30am-12:00pm SESSION 6


Regulatory Operations Outsourcing: Recipe for Success

SESSION CHAIR:

Dominique E. Lagrave, PharmD, MSc Director GRAAS OperationsGlobal Regulatory WritingAmgen

The approach taken by a large and small biotech company towards implementing successful regulatory operations outsourcing will be explored. We will learn the various steps in the set up and management of such initiatives to ensure the best outcome. We will also hear the perspective from a vendor on what to consider to make a true partnership for success. Each speaker will provide case studies.

SPEAKERS:

Meghan Mendoza, MS, MBASenior ManagerRegulatory OperationsAmgen, Inc.

Abhinav GuptaManagerTata Consultancy Services


TRACK 2 - ERS

eCTD v4 / RPS; So Now We Have a Standard, How Do We Implement eCTD v4?

SESSION CHAIR:

Mark A. Gray Senior Project ManagerBioinformatics Support Staff (BSS)CBER/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, document reuse, and support for the exchange of information between regulatory authorities and sponsors. With the achievement of a number of major milestones over the last year the focus is now on planning for the implementation of eCTD v4. This session will provide agency, sponsor, and software 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 IV: It’s Almost As Fun As Super Bowl XLIX

Mark A. Gray Senior Project ManagerBioinformatics Support Staff (BSS)CBER/FDA

Industry Perspective on eCTD v4.0

Boris D. BraylyanSenior DirectorRegulatory Information ManagementPfizer, Inc.

Steps to eCTD 4 Adoption

Joel FinkleAdvisorEmerging PracticesCSC Life Sciences BPS

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with full schedules and limited budgets. DIA can

tailor any training course or curriculum specifically

for your team, department, or entire company.

Contact Jessica [email protected]

16


TRACK 3 – EDM

Trial Master File Reference Model – Preview of Version 3.0 – YOU HEARD IT FIRST!

SESSION CHAIR:

Maryanne QuinnPresidentIntegrated Submission Strategies LLC

This session will provide details on the migration to V 3.0 of the TMF RM, including an overview of the process, the participants, the deliverables and the outreach initiatives. The session will also discuss the physical and technical changes of V 3.0 of the TMF RM and how those changes will affect adopters of the RM, will facilitate navigation. We will also have an industry case study detailing how the company’s TMF was mapped to the TMF RM and their plans for adoption of V 3.0.

Empowering Volunteers to Significantly Impact our Industry – Moving to Version 3 of the TMF Reference Model

Karen Roy, MPharmChief Business Development Officer Phlexglobal Ltd

Todd TullisSenior Product Manager - Vault eTMF Veeva Systems

Case Study #1 - Adoption and Implementation of the TMF RM - The Journey From V1 to V3

Wendy Trimboli Associate DirectorTMF Process Management and Quality ControlGlobal Regulatory Operations, GRAEisai Product Creation Systems (EPCS)

Case Study #2 - Creating a TMF RM Mindset

Donna W. Dorozinsky, RN, MSN, CCRCPresidentDWD & Associates, Inc.


Mergers & Acquisitions: Implications on RIM

SESSION CHAIR:


Attendees will be informed of the various implications mergers & acquisitions have on the Regulatory Information Management (RIM) environment. The session will be broken down into four areas:

• State of the Union regarding M&A in Life Sciences

• A specific look at Sanofi and how their history of acquisitions impacts various systems and processes within Regulatory Operations.

• A call to action for health authorities, vendors, and industry to address the complexities of the M&A environment.

• Open panel discussion with active audience participation.

Global Regulatory Operations Platform and Technology Enablement

Tobias Massa, PhDVice PresidentGlobal Regulatory OperationsSanofi US

Can you Help us Out? A Call to Action for Health Authorities, Vendors, and Industry to Address the Complexities of the M&A Environment

Matthew J. Neal, MADirectorGlobal Regulatory Affairs and SafetyAmgen Inc.

12:00-1:30pm LUNCH / EXHIBITS






17


1:30-3:00pm SESSION 7


Ask The Experts Session

SESSION CHAIR:


PANELISTS:

Brooke Casselberry, MSDirector SolutionsRegulatory SMENextdocs Corporation

Dominique E. Lagrave, PharmD, MSc Director GRAAS OperationsGlobal Regulatory WritingAmgen

Robin A. KeenVice PresidentEnterprise Regulatory Operations ExcellenceJohnson & Johnson

Emily HuddleRegulatory Intelligence ExecutiveGlaxoSmithKline

TRACK 2 - ERS


SESSION CHAIR:


PANELISTS:




Robert Connelly, MBA Product ManagereSubmissions Software GlobalSubmit

TRACK 3 – EDM


SESSION CHAIR:


PANELISTS:

Lisa D. MulcahyOwner, Principal ConsultantMulcahy Consulting, LLC

Laura J. Sherman, MBATraining Partner, Clinical Business OperationsVertex Pharmaceuticals, Inc.

Wendy TrimboliAssociate DirectorTMF Process Management and Quality ControlGlobal Regulatory Operations, GRAEisai Product Creation Systems (EPCS)



SESSION CHAIR:


PANELISTS:Invited

3:00-3:15pm REFRESHMENT BREAK

3:15 –4:45pm CLOSING PLENARY

“Ask The Regulators” Session

SESSION CHAIR:

Mark A. GraySenior Project ManagerBioinformatics Support Staff (BSS)CBER/FDA

PANELISTS:

Mark A. GraySenior Project ManagerBioinformatics Support Staff (BSS)CBER/FDA

Virginia HussongActing DirectorDivision of Data Management Services & Solutions OBI, OSPCDER/FDA

Jared C. Lantzy, PMP Operations Research Analyst Office of Business Informatics (OBI) CDER/FDA

Paul M. LoebachTeam LeaderDrug Registration and Listing ProgramOCCDER/FDA

Norman Schmuff, PhDAssociate DirectorOPQ/OPFCDER, FDA

Lise R. StevensProject ManagerBioinformatics Support Staff (BSS)CBER/FDA

Roberta Szydlo, RPh, MBA, RACSenior Regulatory Review OfficerCDER/FDA

Harald von AschenEnterprise ArchitectFederal Institute for Drugs and Medical DevicesBfArM






18

4:45-5:00pm CLOSING REMARKS

PROGRAM CO-CHAIRS:



5:00pm CONFERENCE ADJOURNED

| Develop | Innovate | Advance

Find out more or register at DIAGlobal.org/DIA2015

It’s a Meeting of the Minds

51ST Annual MeetingJune 14–18 | Walter E. Washington Convention Center

Washington, DC

DIA 20154 Days.20 Tracks.

245+EducationalO�erings.

450+Exhibitors.

7,000+Attendees.

Featured Program Offerings from from the Technology/Data/Records and Submissions Track:

Evolving Your Regulatory Information Management Strategy to Meet the Changing Business Environment

The Critical Role of Document Management Supporting Submissions: Regulatory Operations, IT and Vendor Perspectives

Electronic Standardized Data in Regulatory Submissions

Mapping the Future for Trial Master File: Advancing Standards by Harmonizing Clinical and Technical Strengths

International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP): Will Your Company Be Ready by 2016?

http://DIAGlobal.org/DIA2015