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Regulatory Submissions, Information, and Document Management Forum Primer: February 10 | Short Courses: February 11 | Conference: February 11-13 Bethesda North Marriott Hotel and Conference Center | North Bethesda, MD

#RSIDM19 | DIAglobal.org800 Enterprise Road Suite 200 Horsham, PA 19044 USA As of February 1, 2019

Overview DIA’s Regulatory Submissions, Information, and Document

Management (RSIDM) Forum provides the elements needed

to meet the challenges of optimizing the efficient use of

regulatory information: the RIM principles, effective processes

and tools, benefits to data applications across the product

lifecycle, and examination of real-life results. DIA will present

four tracks and daily health authority plenary sessions to

provide a comprehensive view of content and regulatory

information management and submissions. All tracks are

supported with daily plenary sessions providing regulatory

intelligence updates by health authority representatives from

FDA, Health Canada, and other regions of interest.

Who should attend?Professionals involved in:

• Regulatory Affairs and Operations

• Regulatory Information Management

• Global Submission/Project Management

• Medical, Technical, and Regulatory Writing

• Data Management

• Information Technology and Support

• Document and eRecords Management

• Essential Document Process and Business Systems

• Regulatory Standards Implementation

• Clinical Operations

• Quality Assurance and Compliance

• Contract Researchers and Service Support

• Emerging Pharmaceutical/Biotech/Device

• Vendor Relationship Management

PROGRAM CO-CHAIRS

Brooke Casselberry, MSRADirector, Consulting ExpertCGI Technologies

Michelle Charles, MPH Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center University of Pennsylvania, Perelman School of Medicine

Cindy ChiuDirector, Regulatory Affairs Operations and Quality Management Merck & Co., Inc.

Ron D. Fitzmartin, PhD, MBASenior Project Manager, Office of the Director CBER, FDA

PROGRAM COMMITTEE

V. “Bala” Balasubramanian, PhD, MBAPresident and CEO Cabeus, Inc.

Ethan Chen, MBADirector, Division of Data Management Services and Solutions, OBI, OSP, CDER FDA

Jake DoranChief Technology Officer Genpact Pharmalink

Virginia HussongChief, Data Standards Program CBER, FDA

Joanne MaliaDirector, Clinical Documentation Management Regeneron Pharmaceuticals

Thomas NotoSenior Director, Regulatory Operations Lexicon Pharmaceuticals

Daniel Orfe, MSPresident and CEO Regulatory eSubmissions, LLC

Sarah Powell, RACPresident Powell Regulatory Services

Karen McCarthy SchauDirector, Consulting Services, Health and Life Sciences CGI

Norman Schmuff, PhDAssociate Director for Science, OPS CDER, FDA

Michiel StamRegulatory Information Scientist eCTDconsultancy B.V., Netherlands

Stacy TeganSenior Manager, Regulatory Technology Consulting Accenture

Peter Terbeek, MBASenior Director, Publishing and Submission Astellas

Kevin Tompkins, MBA, MSGlobal Lead, Global Dossier Management, Group Director Bristol-Myers Squibb

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It is designed to enhance your meeting experience and provide valuable information in one place: agenda and speaker information, presentations, connect with attendees and exhibitors, participate in live session polling, and more! NEW to the App this year:

• Channels: Keep the conversation going by utilizing these new Track Channels for RSIDM. It’s a virtual discussion board for all the topics or questions you have regarding all the tracks at RSIDM. Select Channels on the App Menu to access all the track discussion boards

• Q&A: Have a question you would like to see answered live during one of our two Ask the Regulator sessions? Submit your questions by selecting the Question & Answer icon in the bottom toolbar. Select the session where you would like to ask your question and type. You can also submit anonymously – just select that option on the question menu before submitting. Your questions will be stored, reviewed by the panel, and potentially answered live in session!

• Evaluations: We value your feedback and are always looking to improve the RSIDM Forum Access the evaluations by selecting General Information in the App Menu. From General Information select Evaluations button.

Not sure about how to use the App? Join us before the Opening Session Monday, February 11 at 12:30PM in Ballroom E-H for a brief tutorial.

SAVE THE DATE!Regulatory Submissions,

Information, and Document Management ForumFebruary 10-12, 2020

Bethesda North Marriott Hotel and Conference Center

Register today by visiting

DIAglobal.org/RSIDM20

Download the DIA Global App!

Download today by searching “DIA Global” in your app store.


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Schedule-At-A-Glance

PRIMER | SUNDAY, FEBRUARY 10

9:30-10:30AM Primer Registration *Primer requires an additional registration fee. Forest Glen Foyer (Lower Level)

10:00AM-5:00PM Regulatory Content and Submissions Primer: Content from Authoring Through Archive Forest Glen (Lower Level)

DAY ONE | MONDAY, FEBRUARY 11

7:30-9:00AM Short Course Registration *Short Courses require an additional registration fee. Ballroom Foyer (Upper Level)

8:30AM-12:00PM Short Course 1: Blockchain Technology Education Course Brookside (Lower Level)

8:30AM-12:00PM Short Course 2: The Future of Regulatory Affairs White Flint (Lower Level)

11:00AM-5:00PM Forum Registration Ballroom Foyer (Upper Level)

12:40-1:00PM DIA Mobile App Tutorial Ballroom E-H

1:00-1:25PM Welcoming Remarks and Presentation of the Excellence in Service Award Ballroom E-H

1:25-2:00PM Session 1: Keynote Address Ballroom E-H

2:00-2:45PM Refreshment and Networking Break in the Exhibit Hall Ballroom A-D

2:45-4:00PM Session 2: Plenary Session on IDMP Ballroom E-H

4:10-5:25PM Session 3: Other Regions Update Ballroom E-H

5:25-6:30PM Networking Reception in the Exhibit Hall Ballroom A-D

DAY TWO | TUESDAY, FEBRUARY 12

7:30AM-5:30PM Registration Ballroom Foyer

7:30-8:30AM Networking Breakfast in the Exhibit Hall Ballroom A-D

7:30-8:30AM RIM Working Group Open House White Flint

8:30-9:45AM Session 4: FDA – Electronic Submissions Ballroom E-H

9:55-10:45AM Session 5: FDA - Ask the Regulators Part 1 Ballroom E-H

10:45-11:15AM Refreshment Break in the Exhibit Hall Ballroom A-D

11:15AM-12:30PM Session 6: BREAKOUT SESSIONS

Track 1: End-to-End Regulatory Information Management Ballroom FGH Track 2: Enterprise Transformation of RIM with Cloud Capabilities White Oak (Lower Level) Track 3: Can Artificial Intelligence Deliver Value for Content Management in Life Sciences? Brookside (Lower Level) Track 4: eCTD Publishing – eCTD Publishing Management and Efficiencies – Individual Submissions, Lifecycle, and Lifespan of Your eCTD White Flint (Lower Level)





12:30-2:00PM Networking Luncheon in the Exhibit Hall NEW: Solution Showcase Ballroom A-E

2:00-3:15PM Session 7: BREAKOUT SESSIONS

Track 1: Enabling the Use of Labeling Information Ballroom FGH Track 2: Digital Disruption Across Regulatory Affairs White Oak Track 3: eConsent: Permission to Adopt! Brookside Track 4: Teamwork: Other Best Practices for Successful Partnerships White Flint

3:15-4:15PM Refreshment and Networking Break in the Exhibit Hall NEW: Solution Showcase Ballroom A-E


Track 1: The Challenges of Change Management and How Will RIM Systems Improve Our Understanding? Ballroom FGH Track 2: Digital Transformation of Regulatory Affairs Embracing Advanced Technologies White Oak Track 3: Content Migration and Exchange Standards: Perspectives from the Frontline Brookside Track 4: Successful Supplier Partnerships White Flint

6:00PM Dinner on the Town

DAY THREE | WEDNESDAY, FEBRUARY 13


7:30-8:30AM Networking Breakfast in the Exhibit Hall FDA Round Table Discussions Ballroom A-E

8:30-9:45AM Session 9: BREAKOUT SESSIONS

Track 1: Preparing Regulatory Affairs for the Use of SPOR/IDMP and the Benefits it Can Bring Ballroom FGH Track 2: Transforming Regulatory with Digital Technologies White Oak Track 3: Ensuring Part 11/Annex 11 Compliance at Research Sites Brookside Track 4: eSubmissions Revolution 2.0: Leveraging Lessons of Today’s Standards Implementations toPrepare for Increased Use White Flint

9:45-10:30AM Refreshment and Networking Break in the Exhibit Hall Ballroom A-E


Track 1: It Takes a Village - Aka the IRISS Forum Ballroom FGH Track 2: Regulatory Across Platforms and Why it isn’t Boring White Oak Track 3: Innovation in Regulatory Affairs Brookside Track 4: Moving Towards Future Regulatory Processes: The Cloud and Beyond White Flint

11:45AM-1:15PM Networking Luncheon in the Exhibit Hall Ballroom A-E

1:15-2:00PM Session 11: FDA - Ask the Regulators Part 2– Standards for Product Quality, IDMP, and ICSR Ballroom E-H

2:00-2:15PM Closing Remarks Ballroom E-H

2:15PM Forum Adjourns





Learning ObjectivesAt the conclusion of this forum, participants should be able to:

• Explain the regulatory electronic submission process from the completion of its upload to the Electronic System Gateway (ESG) through the time the submission is made available to the review team

• Discuss the agency target time frames for the 1) expected submission upload duration(s) and 2) timeframe between key milestones and notifications

• Describe the current required data standards for regulatory submissions and the status of ongoing data standards initiatives

• Describe organizational processes and governance to ensure integrity, quality, and security of regulatory information (data, documents, records)

• Examine the scope and assess the future of data standards, including IDMP, with respect to systems, processes, and master data

• Discuss ways data can be harmonized, integrated, and viewed to provide an end-to-end view of the regulatory information value chain

• Discuss organizational implications related to increasing electronic interactions with stakeholders and health authorities

• Explain ways to improve processes and communication of regulatory activities including communications, end-to-end processes, and integration of systems for document, submission, and records management

• Interpret global health authority regulations and guidances for systems and business processes

• Identify ways in which the integration of data, documents, and knowledge can be leveraged to develop insights and enable better business decisions

• Identify changes in submission-related regulations impacting RIM business processes

Continuing Education CreditDIA 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 2.1 CEUs 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.

If you would like to receive a statement of credit, you must attend the entire primer, short course, and/or all three days of the forum, sign in each day at the DIA registration desk upon arrival and complete the online credit request process through My Transcript. 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 beginning Wednesday, March 6, 2019.

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• Select My Account from the menu

• Select My Transcripts then Manage My Transcripts





PRIMER | SUNDAY, FEBRUARY 10

9:30-10:30AM Primer Registration *Primer requires an additional registration fee. Forest Glen Foyer (Lower Level)

10:00AM-5:00PM Regulatory Content and Submissions Primer: Content from Authoring Through Archive Forest Glen (Lower Level)

Instructors:Betsy Fallen, RN, Consultant, BAFallen Consulting, LLC

Daniel Orfe, MS, President and CEO, Regulatory eSubmissions, LLC

These talks are designed to meet the needs of individuals who are either new to biopharmaceutical-based regulated document management, information management, and regulatory submission publishing for authorities or already experienced in one area looking to gain a broader understanding. This Primer will present the full spectrum of the regulatory submission, information and document management arena. Understanding the various steps throughout the life of document components from their authoring, publishing to PDF, assembling into a submission, delivery to regulatory agencies, and ultimately company archival will yield “aha” moments for the attendees of this offering from all functions along the life-span of regulatory content. Ice breakers will motivate and the “Hands-On” exercises will provide the attendees the ability to apply material as the day progresses.

This Primer will educate you as well as prepare you to optimize your RSIDM experience. Hands-on use of the DIAglobal app and roadmap to finding relevant sessions will be shared.

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

• Describe the benefits of understanding the complete life phases of regulatory content and the impact that decisions in one place along the life path will have at other stages of the process

• Identify key drivers within each of the life phases and potential pros and cons associated with solution choices

• Recognize the needs of the other organizations involved within the lifespan of the regulatory content and fairly assess their concerns in process and procedure decision-making

• Comprehend the newly released regulations, guidelines, and industry best practices and gain an awareness of their impact

DAY ONE | MONDAY, FEBRUARY 11

7:30-9:00AM Short Course Registration *Short Courses require an additional registration fee. Ballroom Foyer (Upper Level)

8:30AM-12:00PM Short Course 1: Blockchain Technology Education Course Brookside (Lower Level)

Instructors:Brooke Casselberry, MSRA, Director, Consulting Expert, CGI Technologies

Amber Hartley, Chief Corporate Development Officer, BurstIQ

Venkat Kodumudi, Director, Innovation and Outreach, Emerging Technology Practice, CGI Federal, Inc.

This short course will provide the attendees with an education on Blockchain technology. Topics covered in the three hours will include:

• An introductory overview of Blockchain technology, functionality, benefits, and risks

• The types of chains and the pros and cons of each, and the challenges of interoperability

• The differences between the platforms and interfaces in this rapidly changing environment

• Use cases defined in the industry and by both state and federal government

• Guidance on the review and selection process for consideration before beginning a Blockchain project





This short course is intended to be interactive with the audience and there will be many opportunities for attendees to share experiences, ask questions, and challenge current thinking on the technology. Attendees will receive a comprehensive overview and foundations of Blockchain technology.

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

• Identify use cases for blockchain technology

• Develop a blockchain proof of concept project

• Determine applicability of this type of technology

8:30AM-12:00PM Short Course 2: The Future of Regulatory Affairs White Flint (Lower Level)

Instructors:Hans van Bruggen, MSc, Senior Regulatory Affairs Consultant, eCTDconsultancy B.V, Netherlands

Wim Cypers, MPharm, Senior Vice President, Regulatory, ArisGlobal

Michiel Stam, Regulatory Operations Consultant, eCTDconsultancy B.V., Netherlands

During this course the instructors will show how the ongoing and future transformation of regulatory affairs leads to well defined end-to-end business processes. These processes ensure consistent and efficient use of information across documents, data, and dossiers. This is shown by real life examples from various pharma companies. Participants will also learn about best practices for data-, document- and dossier-management.

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

• Define what the future RA processes and workflows must look like

• Identify how RA decision making must be supported by interconnected data, documents and dossiers

• Define lean and reliable E2E Regulatory workflows

• Describe the future roles within the RA department

• See how transformation cannot be driven by technological advancements only

• Distinguish between content and contextual information

• Explain the importance of authoring stand-alone components

• Define document granularity and cross-referencing best practices

• Appraise the role of semantics in information management

11:00AM-5:00PM Forum Registration Ballroom Foyer (Upper Level)

12:40-1:00PM DIA Mobile App Tutorial Ballroom E-H

The DIA Global App is designed to enhance your forum experience and provide valuable information in one place. Download today by searching “DIA Global” in your app store. Come and learn first-hand how to navigate and best use this tool while onsite at the forum.

1:00-1:25PM Welcoming Remarks and Presentation of the Volunteer Award Ballroom E-H

Sudip Parikh, PhD, Senior Vice President and Managing Director, DIA Americas

Track Chairs:Brooke Casselberry, MSRA, Director, Consulting Expert, CGI Technologies

Michelle Charles, MPH, Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center, University of Pennsylvania

Cindy Chiu, Director, Regulatory Affairs Operations and Quality Management, Merck & Co.

Ron Fitzmartin, PhD, MBA, Senior Project Manager, Office of the Director, CBER, FDA

Excellence in Service Award WinnerHans van Bruggen, MSc, Senior Regulatory Affairs Consultant, eCTDconsultancy B.V., Netherlands





1:25-2:00PM Session 1: Keynote Address Ballroom E-H

Keynote Speaker:T.J. Sharpe, PMP, Patient Advocate, Starfish Harbor, LLC

The patient journey to and through a clinical trial may be much different in a clinic than intended in a protocol. Beyond inclusion criteria and schedule of events and the other documented necessities of setting up a trial, there are the unpredictable and immeasurable ripple effects of how, when, and where a clinical trial is available to the biggest trial stakeholders - the patients who look to participate. As a Stage IV melanoma survivor, two-time clinical trial participant, and patient advisor to the pharmaceutical and clinical research industries, T.J. Sharpe shares his story and how the hurdles he faced are representative of the difficulties many encounter as they try and find the right medicine for the right person at the right time.

2:00-2:45PM Refreshment and Networking Break in the Exhibit Hall Ballroom A-D

See Exhibitor Directory in your folder for more details

2:45-4:00PM Session 2: Plenary Session on IDMP Ballroom E-H

Session Chair: Ron Fitzmartin, PhD, MBA, Senior Project Manager, Office of the Director, CBER, FDA

This session will provide an overview of FDA’s perspective and update on conformance to the Identification of Medicinal Product (IDMP) standards.

Craig Anderson, Senior Expert, Program Delivery, Health Canada

Lawrence Callahan, PhD, Chemist, OCS, OCPP, Office of the Commissioner, FDA

Ta-Jen Chen, MS, Project Management Officer, OSP, CDER, FDA

Virginia Hussong, Data Standards Program Manager, OD, BSS, CDER, FDA

4:10-5:25PM Session 3: Other Regions Update Ballroom E-H

Session Chair:Michiel Stam, Regulatory Operations Consultant, eCTDconsultancy B.V. Netherlands

In this session the speakers will share updates about recent and future developments in regulatory guidance and standards across the world. Regions covered include Canada, European Union, Asia and Latin America.

Craig Anderson, Senior Expert, Program Delivery, Health Canada

Lucia Freitas, Regulatory and Pharmacovigilance Head, Biogen Pharmaceuticals , Brazil

Jared Lantzy, PMP, Manager Global Regulatory Agencies and Processes, LORENZ International, LLC

5:25-6:30PM Networking Reception in the Exhibit Hall Ballroom A-D

DAY TWO | TUESDAY, FEBRUARY 12


7:30-8:30AM Networking Breakfast in the Exhibit Hall Ballroom A-D

7:30-8:30AM RIM Working Group Open House White Flint

The Regulatory Information Management Working Group (RIMWG) of DIA’s Regulatory Affairs Community has identified potential benefits that could be captured from the development of a conceptual framework for RIM. Such a framework will aid organizations in structuring the complex organizational, informational, and technological challenges germane to RIM’s myriad of challenges related to cross-functional global data identification, ownership, quality management, and maintenance. Join us during the networking breakfast to learn more about what the RIMWG is up to!





8:30-9:45PM Session 4: FDA – Electronic Submissions Ballroom E-H

Session Chair:Ethan Chen, MBA, Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA

During this session, FDA will provide a summary on electronic submissions. As of May 5, 2017 and May 5, 2018, eCTD is required for NDA, BLA, and ANDA and Commercial IND and DMF submissions, respectively. In addition, studies started as of December 17, 2016 are required to be submitted in standardized format when submitted to NDA, BLA, and ANDA (required for Commercial INDs if study start date is December 17, 2017 or later). FDA will provide an update on submission metrics, processing challenges, and best practices for successful submission.

eCTD Submission Metrics and Guidance UpdateJonathan Resnick, PMP, Project Management Officer, OBI, CDER, FDA

Electronic Submissions Gateway UpdateEthan Chen, MBA, Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA

9:55-10:45AM Session 5: FDA - Ask the Regulators Part 1 Ballroom E-H

Session Chair: Mark Gray, Senior Project Manager, BSS, CBER, FDA

Dedicated to sharing the latest information on new guidances, this session will allow open discussion between the audience and an esteemed panel of regulatory experts. This session provides attendees the opportunity to ask regulators electronic submission process and validation questions, with a focus on the Electronic Submissions Gateway, eCTD, and study data requirements. Questions submitted from attendees may focus on the sessions held during this forum, but can also branch out into other areas. Submit your questions in advance via the Mobile App by selecting “Question & Answer” in the bottom toolbar or email: [email protected].

Please note: due to the high volume of questions, not all will be answered live at the forum.

Ethan Chen, MBA, Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA

LaMisha Fields, IT Program Manager, Electronic Submissions Gateway, OIMT, FDA

Valerie Gooding, Project Management Officer, OBI, OSP, CDER, FDA

Lisa Lin, MBA, PMP, Senior Regulatory Analyst, Office of Director, CBER, FDA

Jonathan Resnick, PMP, Project Management Officer, OBI, CDER, FDA

10:45-11:15AM Refreshment Break in the Exhibit Hall Ballroom A-D

11:15AM-12:30PM Session 6: BREAKOUT SESSIONS

Track 1: End-to-End Regulatory Information Management Ballroom FGH

Session Chair: Michiel Stam, Regulatory Operations Consultant, eCTDconsultancy B.V., Netherlands

E2E solutions are more than a popular buzzword, which is confirmed by the Gens and associates Life Sciences Industry survey 2018; “2020 appears to be a transition point for E2E RIM adoption”. This session provides different definitions for E2E RIM and shows the advantages and disadvantages of various E2E approaches.

Preparing for a Successful RIM ImplementationSandra Brown, MBA, Director, Regulatory Information Management, Abbvie

The Value of Diversity: a Multi-Vendor Approach to End-to-End SolutionsDave Warner, Regulatory Specialist, Generis, United Kingdom

E2E Solutions; More than a Buzzword!Michiel Stam, Regulatory Operations Consultant, eCTDconsultancy B.V., Netherlands




mailto:AsktheRegRSIDM%40DIAglobal.org?subject=


Track 2: Enterprise Transformation of RIM with Cloud Capabilities White Oak (Lower Level)

Session Chair: V. “Bala” Balasubramanian, PhD, MBA, President and CEO, Cabeus, Inc.

Within a few years, the days of trepidation and hesitation over cloud solutions to address business challenges have long gone within the life sciences industry. With the introduction of cloud solutions in commercial and marketing functions, there is increased appetite to replace R&D applications with integrated cloud solutions. Many organizations have embarked on large transformation initiatives around regulatory information management. This session will feature three speakers from a global bio-pharmaceutical company sharing their respective perspectives of a multi-year RIM transformation initiative based on a cloud platform.

Enterprise Transformation of RIM with Cloud Capabilities: People and Process PerspectivesDanielle Beaulieu, PhD, Head, Global Regulatory Business Capabilities, Bristol-Myers Squibb

Enterprise Transformation of RIM with Cloud Capabilities: Technology and Implementation Perspectives Raghunandan Satyanarayan, Associate Director, R&D Architecture, Bristol-Myers Squibb

Enterprise Transformation of RIM with Cloud Capabilities: Data Governance and Data Quality Perspectives Lisa Scott, Director, Data Stewardship and Compliance, Bristol-Myers Squibb

Track 3: Can Artificial Intelligence Deliver Value for Content Management in Life Sciences? Brookside (Lower Level)

Session Chair: Cindy Chiu, Director, Regulatory Affairs Operations and Quality Management, Merck & Co.

The rapid pace of innovation creates opportunities to apply technology to solve complex business problems. Has Artificial Intelligence reached the point of being a useful technology for the Life Sciences enterprise? In this session, we will review the results from an industry survey related to the value of Artificial Intelligence in Life Sciences. The panel will share use cases, and debate on whether this technology should or should not be used. With discussion and interaction, the panel will encourage the audience to ask questions to uncover problems that might be solved with creative uses of artificial intelligence.

What is AI?Lena Shafir, MD, Director, Life Sciences, OpenText

Natural Language Processing in PracticeLena Rampula, Natural Language Processing Capability Lead, MSD Czech Republic, Merck & Co., Inc., Czech Republic

AI in Pharma Content – What IfJames Averback, MS, President, Life Science Integration Partners, LLC

IA with AI: Intelligence Amplification with Artificial Intelligence Karin Schneider, MS, Document Management Enablement Head, Janssen Research & Development

Track 4: eCTD Publishing – eCTD Publishing Management and Efficiencies – Individual Submissions, Lifecycle, and Lifespan of Your eCTD. White Flint (Lower Level)

Session Chair: Daniel Orfe, MS, President and CEO, Regulatory eSubmissions, LLC

Managing the publishing of an individual eCTD sequence is just the starting point. It is critical that lifecycle management be fully understood to provide for efficient and effective eCTD sequence production throughout the lifespan of a drug/biologic. Appropriate strategies and standards establishment can provide for a higher quality eCTD sequence deliverable as well and improved efficiency and turn-around time. This session will bring these important concepts to life over the course of these three presentations and Q&A.





Submission Management and Archiving, Understanding Lifecycle Management Laurie Henricks, Managing Director, Regulatory Submissions Operations, Cardinal Health Regulatory Sciences

Lifecycle Management: Surviving the Chaos Jillian Carinci, MS, Associate Director Regulatory Operations, Biogen

eCTD Reference Citation Construct: What is it, Why it’s needed, Why an Industry Standard Would be Beneficial Daniel Orfe, MS, President and CEO, Regulatory eSubmissions, LLC

12:30-2:00PM Networking Luncheon in the Exhibit Hall Ballroom A-E

Solution Showcase

Check out our NEW Solutions Showcase to see quick fire presentations from our vendors! See flyer in folder for more details.


Track 1: Enabling the Use of Labeling Information Ballroom FGH

Session Chair: Brooke Casselberry, MSRA, Director, Consulting Expert, CGI Technologies

This session brings together representatives from the industry and a regulatory agency (Health Canada) to provide two perspectives on labeling management and the use of labeling information. The industry representative provides an in-depth of knowledge in headquarters and affiliate requirements regarding the process of label content tracking including an overview of technology identified to support these activities. Health Canada’s Structured Product Monograph initiative will lead to the adoption of HL7’s normative SPL standard. The benefits of transitioning from PDF to XML and international data standards will be shared. This session will provide a well-rounded view of industry and regulatory insights on labeling management.

Product Labeling Enablement John Janick, Director, Regulatory Affairs, Information Integration, Merck & Co.

Health Canada on the Structured Product Monograph Project Craig Anderson, Senior Expert, Program Delivery, Health Canada

Track 2: Digital Disruption Across Regulatory Affairs White Oak

Session Chair: Jake Doran, Chief Technology Officer, Genpact Pharmalink

Technology advancements in the regulatory space have long been stifled due to the need to adhere to multiple and sometimes conflicting requirements. As a result, regulatory organizations of today are often unable to keep up with the technology solutions being applied across the drug development spectrum, in other areas such as clinical, safety, or manufacturing. In this session, we will share how digital disruption can be approached within regulatory, how to identify opportunities, develop strategies for ensuring the digital investment is fully realized (in quality, efficiency, and enhanced compliance), and provide examples on building the broader business case to support such investments.

Vada Perkins, Regulatory Policy and Intelligence, Bayer Pharmaceuticals

Armen Kherlopian, PhD, Chief Science Officer, Genpact Pharmalink

Track 3: eConsent: Permission to Adopt! Brookside

Session Chair: Betsy Fallen, RN, Consultant, BAFallen Consulting, LLC

Informed consent is one of the biggest challenges facing clinical trials. The opportunity to digitize the IC and manage it electronically offers many advantages. The panel of key stakeholders will share their experiences and answer your questions.





Sandra Sanford, RN, MSN, Director, Quality Control, Advarra

Mark Gregorio, MSN, Director of Clinical Services, Pfizer Inc

Michael Tucker, Senior Product Solution Specialist, Medidata Solutions

Track 4: Teamwork: Other Best Practices for Successful Partnerships White Flint

Session Chair: Peter Terbeek, MBA, Senior Director, Publishing and Submission, Astellas

Successful submissions require a clear strategy, good communication, delineated roles and responsibilities, and trust in the people and processes. Technical validation is crucial but making the dossier as easy as possible to review is equally important. The presentations in this session will cover the importance of identifying the right team members for various types of submissions/submission strategies and understanding the value and skill sets they bring to the project.

Capturing the Value of Multi-Stakeholder Teams to Support Product Submissions in Emerging Markets Brooke Czapkowski, MBA, Global Submissions Manager, Pfizer, Inc

Achieving a New Drug Application Approval, Who is on Your Submission Team?LaTarsha Jones, MSc, Senior Manager, Global Regulatory Operations Indivior, Inc.

Avoiding Rejections: How Validation and Best Practices Can Lead to Successful SubmissionsSandra Krogulski, MA, Associate Director, Submission Management, Bristol-Myers Squibb

3:15-4:15PM Refreshment and Networking Break in the Exhibit Hall Ballroom A-E

Solution Showcase

Check out our NEW Solutions Showcase to see quick fire presentations from our vendors! See flyer in folder for more details.


Track 1: The Challenges of Change Management and How Will RIM Systems Improve Our Understanding? Ballroom FGH

Session Chair: Sarah Powell, RAC, President, Powell Regulatory Services

This session will examine the challenges associated with dossier change management and review what one organization has done to help address their compliance concerns. The session will also review the findings from 2018 Regulatory Information Management Survey and how industry is looking to maximize value from technology and process improvement initiatives.

Achieving Regulatory Operational Excellence Through Unified Quality and Regulatory Information Management Chester Shemanski, Vice President of Marketing, ENNOV

Dossier Change Control Management: How Changes can be Managed in Industry Christina Frey, Director, Regulatory Affairs, Merck & Co.

RIM Innovation Evolution: Past, Present, Future Trending Steve Gens, MS, Managing Partner, Gens and Associates, Inc.

Professional Development for You and Your Team




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Track 2: Digital Transformation of Regulatory Affairs Embracing Advanced Technologies White Oak

Session Chair: Michiel Stam, Regulatory Operations Consultant, eCTDconsultancy B.V., Netherlands

This session will provide the insight to future of regulatory affairs in the digital world and how companies need to embrace advanced technology to disrupt the traditional way of handling regulatory information and submission process. This session will illustrate the use of artificial intelligence, machine learning, cloud computing, Internet of Things ( IoT), blockchain, etc. in regulatory affairs to reduce the submission cycle time, increase efficiency and productivity, reducing cost of ownership, and increase of compliance adherence.

Ushering Digital Transformation Using Advanced Technology in Regulatory Affairs OperationSusant Mallick, MBA, Head of HCLS, EMEA, Amazon Web Services, Netherlands

Embracing Real World Evidence and Robotic Process Automation to Transform Regulatory Affairs Submission ProcessAmy Cheung, Principal, Deloitte Consulting

Achieving the Benefits of Cloud Technology in Regulatory Operations Marc Gabriel, Senior Director, Vault RIM, Veeva Systems

Track 3: Content Migration and Exchange Standards: Perspectives from the Frontline Brookside

Session Chair:Karen McCarthy Schau, Director, Consulting Services, Health & Life Sciences, CGI

Join battle-scarred experts from Sponsor and CROs who share their migration perils and pitfalls, along with alternatives to achieve migration mastery. The session will feature a panel of migration “veterans” presenting on his/her migration experiences, followed by one overview panel presentation on migration success strategies with interactive panel/audience Q&A. The session ends with an overview and update on TMF RM Exchange Mechanism Standard (EMS).

eTMF-EMS - Towards a First Industry Standard for eTMF Interchange Ken Keefer, MBA, PMP, Principal Consultant, Keefer Consulting, Inc.

Panel Discussion:

Content Migration: Perspectives from the Frontline Joanne Malia, MS, MSc, Director, Clinical Documentation Management, Regeneron Pharmaceuticals

Fran Ross, Senior Consultant, CGI

Jamie Toth, MS, Director/Head of TMF Operations, Daiichi Sankyo, Inc.

Track 4: Successful Supplier Partnerships White Flint

Session Chair: Kevin Tompkins, MBA, MS, Global Lead, Global Dossier Management, Group Director, Bristol-Myers Squibb

Many companies partner with a number of suppliers to help drive efficiences in regulatory operations. A successful partnership for both the sponsor and supplier is critical to the regulatory submission process. This session will focus on the strategies and best practices in a sponsor-supplier partnership to drive optimization of resources in order to deliver high-quality and efficient dossiers to health authorities.

Successful Sponsor-Vendor Relationships Robin Zumbrunnen, Manager, Regulatory Submissions Operations, Cardinal Health Regulatory Sciences

Driving Regulatory Operations Optimization Through Strategic Partnerships Teresa Genthe, MS, Vice President, Regulatory Solutions, Genpact Pharmalink





6:00PM Dinner on the TownTraveling on your own or looking to connect with fellow attendees? Visit the DIA Registration Desk to link up for dinner! Sign-up sheets will be provided for various local restaurants. Cost of dinner is the responsibility of the individual attendee.

DAY THREE | WEDNESDAY, FEBRUARY 13


7:30-8:30AM Networking Breakfast in the Exhibit Hall Ballroom A-E

Two exclusive FDA round tables offered during this time!

FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Events Reports System (FAERS). During this round table discussion, the facilitators will discuss the implementation plan for E2B(R2) IND safety reporting for drugs and biologics at FDA.

Visit https://www.supersaas.com/schedule/DIA/RSIDM_FDA_Round_Tables to sign up! Limit to nine slots at each table.

Meredith Chuk, MD, MHS, Medical officer, OHOP, CDER, FDA

Suranjan De, Deputy Director, Regulatory Science, OSE, CDER, FDA


Track 1: Preparing Regulatory Affairs for the Use of SPOR/IDMP and the Benefits it Can Bring Ballroom FGH

Session Chair: Sarah Powell, RAC, President, Powell Regulatory Services

This session will review the current status of IDMP implementation in the EU and the impact of SPOR on regulatory teams today, and in the future. The session will also review how effective data information management can provide benefits beyond compliance with regulations.

Preparing for SPOR in Europe: What Are the Latest Developments in the EU Implementation of IDMP and What Can You do Now? Kelly Hnat, Principal, K2 Consulting

The Use of SPOR/IDMP and the Impact on Regulatory Affairs and RIM Solutions in the EU Remco Munnik, Regulatory Information Director, Asphalion, Spain

Turning IDMP into a Data and Information Management Project with Benefits Outside of Compliance Andrea Herrmann, PharmD, Head of IDMP Office, Merck KGaA, Germany

Track 2: Transforming Regulatory with Digital Technologies White Oak

Session Chair: V. “Bala” Balasubramanian, PhD, MBA, President and CEO, Cabeus, Inc.

This session will explore the use of digital technologies including AI and ML in regulatory, especially in the areas of regulatory operations, submissions management, and archiving, among others. It will cover potential use cases to improve compliance, efficiency and automation, as well as an action plan to implement AI and ML within regulatory.

Exploring Digital Technology in Regulatory Affairs Scott Cleve, Head of Global Regulatory Operations, Boehringer Ingelheim, Germany

Introducing AI and Automation with Submission Management Brian Burke-Green, MSc, Regulatory Manager, Pfizer, Inc

The Compliment of AI Within Life Sciences Rob Connelly, MBA, Senior Director, Product Management, Synchrogenix




https://www.supersaas.com/schedule/DIA/RSIDM_FDA_Round_Tables


Track 3: Ensuring Part 11/Annex 11 Compliance at Research Sites Brookside

Session Chair: Joanne Malia, MS, MSc, Director, Clinical Documentation Management, Regeneron Pharmaceuticals

With the proliferation of electronic trial master files (eTMFs), electronic consent (eConsent) and other electronic regulatory document management systems in use at sites, sponsors and CROs are at risk of compliance findings if they do not have strategies in place to ensure sites comply with 21 CFR 11 and Annex 11 regulations. In this session we will discuss various aspects and best practices for helping sites build an appropriate risk based approach to Part 11 compliance for their “eSystems”. Tools will be explored to help sites understand their commitments and document their compliance with the appropriate regulation.

Ensuring Part 11/Annex 11 Compliance at Research SitesJames Riddle, MCSE, CIP, CPIA, Vice President of Client Services, Kinetiq, a Division of Quorum IRB

Preparing Research Sites for eSource with Part 11 Compliant ToolsRaymond Nomizu, JD, Co-Founder, CRIO, Inc.

Case Examples of the Review of Data Integrity Controls in GCP InspectionsCheryl Grandinetti, PharmD, Health Scientist, Policy Analyst, OSI, OC, CDER, FDA

Track 4: eSubmissions Revolution 2.0: Leveraging Lessons of Today’s Standards Implementations to Prepare for Increased Use White Flint

Session Chair: Stacy Tegan, Manager, Regulatory Technology Consulting, Accenture Accelerated R&D Services

It’s been almost 20 years since submissions were revolutionized to become “electronic.” Since that time, the way we access and consume information in every aspect of our lives has changed dramatically. It’s time for another revolution for submissions – one that will leverage structured contact and data standards. What changes are coming? What lessons of experience can we apply in the future? Session includes a case study of SEND standard implementation.

eSubmission Evolution: Structured Data and Data StandardsJared Lantzy, PMP, Manager Global Regulatory Agencies and Processes, LORENZ International, LLC

SEND: What is it and Where Are We as an Industry?Fred Wood, PhD, Vice President, Consulting Services, Data Standards Consulting Group, A Division of TalentMine

Standards Implementation: BMS Case Study and Plans for Expanding Use of SENDKatherine Dubrow, Research Scientist, Bristol Myers Squibb

9:45-10:30AM Refreshment and Networking Break in the Exhibit Hall Ballroom A-E


Track 1: It Takes a Village - Aka the IRISS Forum Ballroom FGH

Session Chair: Brooke Casselberry, MSRA, Director, Consulting Expert, CGI Technologies

Change continues to happen with the implementation of regulatory information submission standards across the globe. Are the processes at your company currently regarding existing standards? Do you know what new standards are on the horizon? Within your company, are you planning and making changes to meet 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 issues with the implementation of standards.





How far the Village has Come in 10 Quick YearsSue Metz, CEO and President, IRISS Forum

CMC Books of KnowledgeMarie Parrish, PhD, MS, IRISS CMC Topic Group Leader, IRISS Forum

Role of IRISS IDMP Topic Group in SPOR and IDMP DevelopmentsFrits Stulp, MSc, Managing Director, Iperion Life Sciences Consultancy, Netherlands

Track 2: Regulatory Across Platforms and Why it isn’t Boring White Oak

Session Chair: Jake Doran, Chief Technology Officer, Genpact Pharmalink

This session will focus on the impact of technology, efficiency, knowledge management, and how the consumer information paradigm will impact the future of RIM. In the very small niche market of pharmaceuticals and biotechnology, the established vendors are well known…but are they?

Current software and solutions grew directly out of regulatory requirements at global health authorities. As standards evolve, companies look to change systems to maximize value, streamline operations, decrease total cost of ownership, and increase compliance. The future of digital technology and the influx of Behemoth Tech companies into Pharmaceutical Operations is going to change everything. The impact of big technology R&D money now focused on this area will influence the pharmaceutical operational landscape in ways we may not yet fully understand. What was once a playing field of upstart companies is now big opportunity for tech giants to change the way we do business and get medicine to patients faster and in novel ways. This session will illustrate how technology, innovation, and fresh perspective can transform regulatory stuff from boring to indispensable.

Regulatory is BoringMatt Neal, MA, Senior Director, product Management, Regulatory and Clinical Solutions, PAREXEL International

Meredith Sewell, Executive Director, Global Regulatory Submissions, Allergan

Track 3: Innovation in Regulatory Affairs Brookside

Session Chair:Karen McCarthy Schau, Director, Consulting Services, Health and Life Sciences, CGI

In the last three to five years, application of technology trends like Robotic Process Automation, Artificial Intelligence, Natural Language Processing, and Deep Learning has increased gradually in other industries as well as in life sciences. Additionally, Life Sciences organizations today are focused on addressing an increasing number of regulatory requirements which span across geographies, business activities and functions. These presentations will introduce the audience to these trends, discuss their application more broadly across various industries, and make a case on how application of such technologies could benefit regulatory affairs tremendously and drive innovation. Regulatory affairs function is key to improving document management, along with the process controls associated with regulatory submissions that increase efficiencies of the entire product development value chain and reduce time-to-market. This knowledge can be leveraged by sponsors and vendors in revisiting their Regulatory Intelligence Platform strategy and potentially undertake pilots and business cases in investing further to drive programs in their organizations.

Building Next Generation Regulatory Intelligent Platform Using Innovative Technologies Like Automation, AI, and Deep Learning Venugopal Mallarapu, MS, Practice Director, Life Sciences, Cognizant

Leveraging End-to-End RIM to Drive Innovation in Regulatory AffairsDavid Gwyn, MBA, Global Solutions Architect, AMPLEXOR Life Sciences





Track 4: Moving Towards Future Regulatory Processes: The Cloud and Beyond White Flint

Session Chair: Thomas Noto, Senior Director, Regulatory Operations, Lexicon Pharmaceuticals

This session will provide an overview of state-of-the-art regulatory processes. We will highlight the opportunities for process improvement through the use of cloud-based eDMS and eCTD solutions, control of document delivery, text mining, etc. New technologies such as Natural Language Processing and Artificial Intelligence will be explored. We will also give an overview of current and future developments to connect structured and unstructured content with the goal to gain efficiencies, reduce repetitive tasks, and increase data quality and consistency.

Brave New Regulatory World: Digitally Transforming Pharma’s Regulatory ProcessesTimm Pauli, Senior Director, eSubmission Services, Head of Regulatory Operations, Pharmalex GmbH, Germany

Transforming an Organization’s Regulatory Processes into an Efficient Cloud-Based SystemThomas Noto, Senior Director, Regulatory Operations, Lexicon Pharmaceuticals

Cloud-Based eCTD: A Case Study Heather Fisher, MS, Senior Manager, Regulatory Operations, Arivis, Inc.

11:45AM-1:15PM Networking Luncheon in the Exhibit Hall Ballroom A-E

1:15-2:00PM Session 11: FDA - Ask the Regulators Part 2– Standards for Product Quality, IDMP, and ICSRs Ballroom E-H

Session Chair: Norman Schmuff, PhD, Associate Director for Science, OPQ, CDER, FDA

Dedicated to sharing the latest information on new guidances, this session will allow open discussion between the audience and an esteemed panel of regulatory experts. This session will focus on PQ/CMC, IDMP, and E2B.Submit your questions in advance via the Mobile App by selecting “Question & Answer” in the bottom toolbar or email: [email protected].

Please note: due to the high volume of questions, not all will be answered live at the forum.

Ta-Jen Chen, MS, Project Management Officer, OSP, CDER, FDA

Suranjan De, Deputy Director, Regulatory Science, OSE, CDER, FDA

Ron Fitzmartin, PhD, MBA, Senior Project Manager, Office of the Director, CBER, FDA

Virginia Hussong, Chief, Data Standards Program, CBER, FDA

Mark Gray, Senior Project Manager, BSS, CBER, FDA

2:00-2:15PM Closing Remarks Ballroom E-H

2:15PM Forum Adjourns

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